Site Master File

Document No.
WB/SMF/QF/001
Effective Date 01-01-2019
Revision No. 00
Rev:
Replaces
SITE MASTER FILE Dated:
Not Valid without Signatures
Issued By: Reviewed By: Approved By: Authorized By:

Manager Quality Assurance Production Manager Manager Quality Control Plant Manager
ISO 9001:2015
QUALITY MANAGEMENT SYSTEM
SITE MASTER FILE

Manufacturing Facility:
M/s. Wellborne Pharmachem & Biologicals

Address: Plot No. 51/1, 52/2 Phase-II, Industrial Estate, Hattar.
Phone No. 0995617333

Email: info@wellbornepharma.com / borne.well@yahoo.com
Company Logo:
INDEX
Sr. No CONTENT
1.0 GENERAL INFORMATION
1.1 Brief Information Of The Firm
1.2 Pharmaceutical Manufacturing Activities
Copy # Controlled Copy: Not to be duplicated Page 1 of 60
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1.3 Other Manufacturing Activities At The Site

1.4 Name And Address of The Site
1.5 Type of Products Manufactured At The Site
1.6 Description of The Site & Plant Installed Capacity
1.7 Employees Details
1.8 External Technical Assistance
1.9 Quality Management System
2.0 PERSONNEL
2.1 Organogram.
2.2 List of Technical Staff
2.3 Training (Basic & In-Service)
2.4 Health Requirements For Personnel
2.5 Personnel Hygiene Requirements, Including Clothing
3.0 PREMISES AND EQUIPMENT
3.1 Description of Manufacturing Areas
3.2 Nature of Construction And Finishes
3.3 Brief Description of Ventilation System
3.4 Description of Water System
3.5 Maintenance of Premises
3.6 Major Production And Laboratory Equipment
3.7 List of Critical Machine and Laboratory Instruments.
3.8 Maintenance of Equipment
3.9 Qualification, Calibration And Validation
3.10 Sanitation
4.0 DOCUMENTATION
4.1 Preparation, Revision And Distribution of Documentation
4.2 Other Documentation Related To Product Quality
4.3 Additional Documentation
5.0 PRODUCTION
5.1 Brief Description of Production Operations
5.2 Handling of Materials
5.3 Reprocessing / Rework
5.4 Handling of Rejected Materials
5.5 Process Validation
6.0 QUALITY CONTROL
6.1 Quality Control System
7.0 DISTRIBUTION, COMPLAINTS AND PRODUCT RECALL
7.1 Storage and Distribution Practices
7.2 Complaint Handling
7.3 Product Recalls
8.0 SELF INSPECTION

8.1 Self-Inspection System
9.0 DRUG MANUFACTURING LICENSE (DML)
10.0 GOOD MANUFACTURING PRACTICES (GMP) CERTIFICATE
11.0 ISO CERTIFICATE
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Terms & Definitions:
TERMS DEFINITIONS
Accident Undesired event giving rise to death, ill health, injury, damage or other loss.
Audit Systematic, independent and documented process for obtaining evidence and evaluating
it objectively to determine the extent to which the audit criteria are fulfilled
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Audit Conclusions Outcome of an audit decided by the audit team after consideration of all the audit findings
Audit Criteria Set of policies, procedures, or requirements against which collected audit evidence is
compared
Audit Evidence Records verified statements of fact or other information relevant to the audit.
Audit Findings Results of the evaluation of the collected audit evidence against audit criteria
Audit Program Set of audits to be carried out during a planned timeframe
Audit Scope Extent and range of a given audit
Audit Team One or more auditors conducting an audit, one of whom is appointed as leader
Auditee Organization being audited
Auditor Person qualified and competent to conduct audits
Capability Ability of an Organization, system, or process to realize a product that fulfils the
requirements for that product
Child Any person less that 15 years of age
Child Labor Any work by the child younger than the age specified in the definition of child except as
provided for by ILO Recommendation 146.
Concession Authorization to use or release a product that does not conform to the specified
requirements
Conformity Fulfillment of a requirement.
Continual Process of enhancing the Quality System to achieve improvement in overall performance
Improvement in line with the Organization’s policy
Continual Process of enhancing the Quality System, to achieve improvement in overall performance
Improvement inline with the Organization’s policy.
Correction Action taken to eliminate a detected nonconformity.
Corrective Action Action taken to eliminate the cause of a detected nonconformity or other undesirable
situation.
Customer Organization or person that receives a product
Customer Customer’s opinion of the degree to which a transaction has met the customer’s needs
Satisfaction and expectations
Design and Set of processes that transforms requirements into specified characteristics and into the
Development specifications of the product realization process
Document Information and its support medium
Environment Surroundings in which an Organization operates, including air, water, land, natural
resources, flora, fauna, humans and their interrelation
Environmental Element of the Organization’s activities, products or services that can interact with the
Aspects environment
Environmental Impact Any change to the environment, whether adverse or beneficial, wholly or partially resulting
from an Organization’s activities products or services.
Forced Labor All work or services that is extracted from any person under the menace of any penalty for
which said person has not offered him/herself voluntarily.
Guideline Document stating recommendations or suggestions
Hazard Source or situation with a potential for harm in terms of injury or ill health, damage to
property, damage to the workplace environment, or a combination of these.
Hazard Identification Process of recognizing that a hazard exist and defining its characteristics
Incident Event that gave rise to an accident or had the potential to lead to an accident.
Inspection Conformity evaluation by observation and judgement accompanied as appropriate by
measurement, testing or gauging.

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Interested Parties Person or group having an interest in the performance or success of an Organization
Quality System System to establish policy and objectives and to achieve those objectives
Measurement Set of operations having the object of determining the value of a quantity
Measurement Control Set of operations necessary related to achieve meteorological confirmation and
System continuous control of measurement processes
Measurement Set of interrelated resources, activities, and influences related to a measurement
Process
Measuring Instrument, measurement standard, reference material and/or auxiliary apparatus
Equipment necessary to implement a measurement process for carrying out a specified and defined
measurement
Non-conformity Non-fulfillment of a requirement.
Objective Evidence Data supporting the existence or verity of something.
Occupational Conditions and factors that affect the well being of employees, temporary workers,
health and safety contractor personnel, visitors and any other person in the workplace.
Organizational Orderly arrangement of responsibilities, authorities and relationships between people
Structure
C.1 General Information:

C.1.1 Brief Introduction:
Upon establishment in 2009, WELLBORNE had envisioned a self-dependant Pakistan producing
superior quality medicines.

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A state of the art manufacturing facility was setup to manufacture and market pharmaceutical
formulations for human therapeutic use. It includes a range of dosage forms that includes Solid and
Liquid oral dosage forms (Tablets, Capsules, Syrups, Suspensions and Dry suspension), and Injections
(Liquid ampoules, Infusions, Dry powders).
1.2. PHARMACEUTICAL MANUFACTURING ACTIVITIES AS LICENSED BY THE GOVERNMENT

AUTHORITIES
Pharmaceutical manufacturing activities in our country are controlled by the Drug Regulatory Authority,
Ministry of Health Pakistan. Licensing and controlling activity is under the control of Chief Executive
Officer, Drug Regulatory Authority Ministry of Health Pakistan. As per the Drugs Act 1976 and Rules
there under, the Chief Executive Officer, Drug Regulatory Authority Ministry of Health Pakistan,
approves all the new products after the submission of necessary data. The labeling of drug products is
also controlled by the above Act, as well as any additional specific instructions given by the Chief
Executive Officer, Drug Regulatory Authority Ministry of Health Pakistan at the time of New Product
licensing.
WELLBORNE (Pvt.) Limited is involved in the manufacturing of products in the Pharma health, with a
Drug Manufacturing License number 000657. In Pharma health we manufacture a range of dosage
forms that includes Solid and Liquid oral dosage forms (Tablets, Capsules, Syrups, Suspensions and Dry
suspension), and Injections (Liquid ampoules, Infusions, Dry powders).
1.3 OTHER MANUFACTURING ACTIVITIES AT THE SITE

No other manufacturing activities, except those for which the company has the Manufacturing License
issued by the Drug Regulatory Authority Ministry of Health Pakistan, are carried out at the site.
1.4 NAME AND ADDRESS OF THE SITE
M/s. Wellborne Pharmachem & Biologicals.

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Address: Plot No. 51/1, 52/2 Phase-II, Industrial Estate, Hattar.
Phone No.:
0995617333
E-mail: info@wellbornepharma.com / borne.well@yahoo.com
Details of Contact Persons:
Sr. No. Name of the Person Designation Phone No.
1 Mr. athar Rana CEO 03215050600
1.5 TYPES OF PRODUCTS MANUFACTURED AT THE SITE
List of Products Licensed attached as under (Pharmaceuticals Health)
The company has a number of registered products for both Sterile & Non Sterile Preparations in the
following therapeutic range:
 Antibiotics
 Anti Malarial
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 Anti Diabetics
 Cardiovascular
 Anti Psychotics
 Anti Allergic
 Anti Inflammatory Analgesics
 Anti Fungal
 Corticosteroids
 Anti Ulcers
 Anti Protozoal
 Anti helminthes
1.6 DESCRIPTION OF THE SITE

1.6.1. Infrastructure:
Wellborne Pharmachem & Biologicals (Pvt.) Ltd has set up the pharmaceutical manufacturing facility at
Plot No. 51/1, 52/2 Phase-II, Industrial Estate, Hattar.
The factory has excellent infrastructure like roads, streetlights, underground drainage system, etc. The
Plant is provided with a new water purification system, excellent manufacturing and packing
equipments.
The Production Department comprises of two separate buildings –Pharma Health Division for general
category formulations of Pharma health products and Isolated Formulation for Manufacturing of
Cephalosporin products. The service departments include Raw Materials Stores, Packing Materials
Stores, Finished Goods Warehouse, Quality Control Laboratory & Quality Assurance, Security
Department, Account & Administration and Industrial Safety Section under Engineering Department.
Plant has all the modern facilities of international standards. We have latest machines in our production
departments. For the accurate testing in-house specifications are developed at very high standard.
Stability and periodical testing is strength of our system by which we provide superior quality products.
The construction of the buildings has been done insuring the protection from contamination. Floor is
encrusted with vinyl flooring sheet in such a way to ensure a smooth coving between walls and floors.
Sloping is made in such a way that water do not store on the floor. The birds, insect, dust, rodent
cannot come inside. Toilets are situated far from production area and storage area to avoid
contamination. The light fixers in production and Quality Control area are easily cleanable. Cabins are
provided for every machine to avoid contamination. Uniflow system is observed to avoid contamination.
Adequate place is provided for working process. Doors and windows are made of powder coated metal,
hydraulic door closers are provided to shut the door at once. Glass fitted with windows is smooth and
no uneven surface is there. All the entries in the production area are through corridor to avoid the
direct exposure to outer environment. Double door entry is made to minimize the contamination in the
production area. Filtered air is provided in every section separately through ducts by Air Handling Unit
(AHU). In the sections where temperature is to be controlled, their AHU air comes through AC.
Dehumidifiers and compressors are provided where required.
1.6.2. SIZE OF SITE & AREA
Total Area: 2 Acre
Total covered Area: 22000 Sq. Ft

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Production covered Area: 19380 Sq. Ft
1.7 LIST OF TECHNICAL STAFF

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S.NO. NAME DESIGNATION QUALIFICATION EXPERIENCE
1 Mr. Ifthikhar Ahmad khan Production Manager B. PHARMA 20 Years
2 Mr. Mohammad Zubair Production Manager B. PHARMA. MPhil 10Years
3 QC Manager 10 Years
4 Miss Masooma Microbiologist MPhil Microbiology 02 Years
5 Mr. adil shah QA Inspector B.Sc. 02 Years
6 M.Zain Qc Analyst MSC Chemistry 01 Years
7 M.Saquib Production Pharmacist Pharm. D 03 Years
1.8 EXTERNAL TECHNICAL ASSISTANCE
Our Quality Control facilities are self sufficient and well equipped. However, assistance from the
government approved testing laboratories is sought, if required:
1.9 QUALITY MANAGEMENT SYSTEM
1. Quality Policy:

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Quality Policy
WELLBORNE’s mission is to bring value to the patients and customers

through its innovative, high quality products, which improves sustain or
restore health.
WELLBORNE’s is striving to be leader among all national companies in all of its

business activities in health care. In order to achieve this, the highest
possible level of professionalism is needed in all of our endeavors. This code of
conduct is an expression of the professionalism
we except of our associates.
As an ethically, socially and ecologically responsible organization, WELLBORNE

places premium on dealing fairly with employees, commercial partners,
Government authorities and public, success in its business ventures
depends upon maintaining the trust of these essential stakeholders. This
principal is fundamental to the task of creating and maintaining such trust.
WELLBORNE’s considers these principals to be essential

in its relations with its employees. It shall from an integral part of the terms
of employment of the WELLBORNE’s
WELLBORNE’s is striving to continuously improves all of its processes through

a target approach and better customer service.
WELLBORNE’s will insist on full compliance.
Dr. Athar Rana
(CEO)
The Organization has established, documented, implemented, maintains and continually improves the
following;
 Quality Management System, covering the requirements of ISO 9001:2015.
2. General Requirement of Quality Management system:
To implement these Quality Systems, the Organization has managed to;

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 Identify the processes and its potential environmental, safety and health impact needed for the
Quality Systems
 Determine the sequence and interaction of these processes
 Determine criteria and methods required to ensure the effective operation and control of these
processes.
 Ensure the availability of information necessary to support the operation and monitoring of these
processes.
 Measure, monitor and analyze these processes.
 Implement actions necessary to achieve the planned results and continual improvement.
The Organization manages these processes in accordance with the requirements of these standards.
3. Documentation Requirements
The Organization has prepared its Quality System documentation, which includes;
 Quality Manual
 Standard Operating Procedures
 Standard Analytical Procedure
 Batch Manufacturing Record
 Master Formula’s
 Material Specifications (Raw & Packaging)
 Job Descriptions
 Quality Drawings
 Quality Forms
3.1 Control of Documents
The Organization has established a procedure for controlling documents used in its Quality System.
This control ensures that the;
 Documents are approved for adequacy prior to release.
 Documents are reviewed, updated as necessary.
 Documents are identified with current revision status.
 The relevant versions of documents are available at all locations where necessary.
 Documents remain legible, readily identifiable and retrievable.
 Obsolete documents are removed from all points of issue or use, or are otherwise controlled to
prevent unintended use. Any obsolete documents retained for legal or knowledge preservation
purposes are suitably identified.
3.2 Control of Records

Quality records are maintained, controlled, identified, stored, retrievable, protected, disposed after
retention time as per procedure to demonstrate conformance to requirements and effective operation of
the Quality System.
4. Management Commitment:
The Organization’s management is fully committed to quality and demonstrates its commitment to the
development and improvement of the Quality System by:
 Communicating at all levels in the Organization the importance of meeting customer requirements,
as well as regulatory and legal requirements for production of quality products.
 Establishing the Organization’s Policy and Objectives, and ensuring that it is implemented effectively
at all functions and levels.
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 Performing Management Review and ensuring that quality performance is effectively reviewed at
relevant levels.
 Ensuring the availability of necessary resources for the fulfillment of needed quality standards.
The Organization produces products that fully and consistently satisfy the needs of our customers.
Quality achievement, its maintenance and its further improvement is the responsibility of all employees
of the Organization irrespective of their other duties.
To demonstrate to both our customers and staff, the Organization’s commitment to quality is to
implement and maintain the Quality System that complies with the requirements of standards. The
requirements of the system are binding on all Organization personnel and no unauthorized alteration
and deviations are permitted.
5. Management Focus
The Organization’s management, at appropriate levels, determines appropriate product quality needs
and converts them into the form of defined requirements.
The Organization is having a goal of achieving customer confidence and maintaining safe,
environmental friendly and healthy atmosphere within the Organization as well as to the community.
International Standards and Regulatory requirements are properly considered while determining the
needs for quality product, controlled environment, and employee health and safety.
6. Customer Focus
The Organization’s management meets the customer expectations and satisfaction level for the quality
product by ensuring through:
 Customer Requirements.
 Customer Communication.
 Customer Complaints.
 Customer Feedback.
 Post Market Surveillance
7. Objectives and Targets

The Organization has established quality objectives and targets at appropriate functions and levels.
These objectives are defined in measurable terms and are the interpretation goals of policy deployment
in each department/section. These objectives are set annually in the Management Review consistent
with the Organizational policy, and the commitment to continual improvement and meeting
management focus and regulatory requirements.
8. Implementation Plans
The Organization has established plans identifying the resource needed to achieve the quality objectives
and targets.
Implementation plans covers the following issues:
 The processes of the Quality System, considering permissible exclusions.

 The resources needed.
 Continual improvement of the Quality System.
 Target date for the completion of objectives
Implementation Plans ensures that change is conducted in a controlled manner and that the integrity of
the Quality System is maintained during such changes
9. Legal and Regulatory Requirements
The Organization has established and maintained a procedure to identify and have access to legal and
regulatory requirements to which the Organization subscribes, that are applicable to the activities of the
Organization. The General Manager Plant Operations is responsible for keeping the legal and regulatory
requirements up dated at all times.
10. Responsibility and Authority
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Functions and their interrelationships within the Organization including responsibilities, authorities and
accountability are defined and communicated in order to facilitate effective management. The Job
Description describes the responsibilities and authorities of the Organization’s personnel. The relevant
Standard Operating Procedures also describe the responsibilities of personnel in relation to various
quality system requirements.
1.9.1. QUALITY POLICY
Quality Policy
WELLBORNE’s mission is to bring value to the patients and customers

through its innovative, high quality products, which improves sustain or
restore health.
WELLBORNE’s is striving to be leader among all national companies in all of its

business activities in health care. In order to achieve this, the highest
possible level of professionalism is needed in all of our endeavors. This code of
conduct is an expression of the professionalism
we except of our associates.
As an ethically, socially and ecologically responsible organization, WELLBORNE

places premium on dealing fairly with employees, commercial partners,
Government authorities and public, success in its business ventures
depends upon maintaining the trust of these essential stakeholders. This
principal is fundamental to the task of creating and maintaining such trust.
WELLBORNE’s considers these principals to be essential

in its relations with its employees. It shall from an integral part of the terms
of employment of the WELLBORNE’s
WELLBORNE’s is striving to continuously improves all of its processes through

a target approach and better customer service.
WELLBORNE’s will insist on full compliance.
Dr. Athar Rana
(CEO)
C.1.9.2 Define the Responsibility of Quality Assurance Functions
Quality Assurance Function

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Physical Lab/ Documentation & RecordMonitoring

Control of stability studies
In-process Control Validation Calibration
Responsibilities
a. Quality Assurance Manager
i. To monitor that all the activities in the plant are being performed in accordance with WHO
guide lines, cGMP, ISO 9001: 2015 standards.
ii. To manage all activities of Quality Assurance Department in accordance with documented
procedure.
iii. To manage all the activities of Physical Laboratory, In-process Inspection, Calibration,
Validation, and Stability Studies.
iv. Ensure the performance of quality services.
v. Ensure that each and every activity performed in Quality Assurance Department is carried out in
accordance with documented procedures and records are maintained for Traceability purposes.
vi. Ensure that each and every materials, product, machine, stage is identified.
vii. Ensure that the customer requirements are understood and are complied with.
viii. Ensure that the regulatory requirements are complied.
ix. Ensure that a production and service process is safe and environmental friendly for personnel and
community.
x. Ensure that facility, machine and equipment, personnel, are handled safely.
xi. That trained staff are used for specialized work.
xii. That nonconforming product is identified and treated as per approved decision.
xiii. To release the product for sale.
C.1.9.3 Elements of Quality Assurance System:

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Quality Assurance Manager
Deputy Manager
Assistant Manager Assistant Manager

Calibration/Validation In-process Control
QA Inspector
a. Maintaining Working Conditions
General: Applicable throughout Quality Assurance Department:
i. Control of Substances Hazardous to Human and Environment:
 All substances having potential for causing harm to human and environment are identified.
 Each identified hazardous substance has a Material Safety Data Sheet, which includes information
about composition of the product as well as handling, disposal and first aid precautions.
 It is the responsibility of all the staff to be aware of possible danger when handling any substance,
and precautionary measures are taken, like wearing of protective clothes, glasses, gloves, mask
etc.
 It is the responsibility of all staff to be aware of First Aid/ fire fighting application in case of any
accident.
b. Identification and Traceability
Quality Assurance Department is responsible for identifying the status of products, where applicable, by
suitable means throughout product realization. The status of the product with respect to measurement
and monitoring requirements is identified during all stages of production provision. Also to ensure
Traceability of products, the unique identification of products or their batches are controlled and
recorded. In addition to above, the Organization maintains the identification of Environment, Safety and
Health Hazards.
c. Control of Nonconformity
The controls and related responsibilities and authorities for dealing with non-conformity are defined and
documented.

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The nonconformity is dealt with in any of the following ways:
i. By taking actions to eliminate the detected nonconformity.

ii. By authorizing its use, release or acceptance under concession by the relevant authority and,
where required, by customer.
iii. By taking actions to preclude its original intended use or application.
Records of nature of nonconformity and any subsequent actions taken are maintained. Any
nonconforming product that has been re-processed is subjected to re-verification to ensure
conformity to the requirements.
In case the nonconformity is detected after delivery, the Organization takes action appropriate to
the effects, or potential effects, of the nonconformity.
d. Customer Satisfaction
i. Customer Complaints
Written and verbal Customer Complaints are received by GM Plant Operations. In case of verbal
customer complaints, these are noted down on Customer Complaint form by GM Plant Operations
for investigation. The Customer Complaint Form is then sent to Quality Assurance Manager for
further investigation.
The Quality Assurance Manager enters the Customer Complaints Number and brief description in
Customer Complaints Register.
ii. Customer Feedback

The customer feedback is taken by Marketing Department to ensure the customer satisfaction and
to identify the customer problems and requirements for further enhancement of customer
satisfaction.
e. Internal Audits:
The internal audits arts as a management tool for independent assessment of any designated
process or activity in obtaining objective evidence that the existing requirements have been met.
Quality Assurance Department is responsible to establish process for performing internal audits in
order to determine if the Quality System conforms to the requirements of this international
standard and has been effectively implemented and maintained.
The Organization plans audit program, which is based on the status and importance of the
activities, areas or items to be audited, and the results of previous audits.
Audits are performed by personnel other than those who performed the work being audited. The
management of the Organization takes timely corrective actions on deficiencies found during
audit. Follows up actions include the verification of the implementation of corrective action and the
reporting of verification results.
f. Continual Improvement
The Quality Assurance Department is responsible to improve Quality System through the use of
Quality Policy, quality objectives, audit results, analysis of data, corrective and preventive action
and management review. The quality objectives are up-graded gradually on routine basis for
improving performance of different departments.
g. Corrective Action
The Organization takes action to eliminate the causes of non-conformities in order to prevent
recurrence. The extent of corrective actions taken depends on the impact of the problems
encountered.
The procedure for the corrective action process includes:
i. Identification and review of non-conformities.

ii. Determination of causes of non-conformities.
iii. Evaluation of the need for actions to ensure that non-conformities do not recur.
iv. Determination and Implementation of any actions necessary to ensure that non-conformities
do not recur.
v. Recording results of actions taken.
vi. Follow-up to ensure corrective action taken is effective and recorded.
1. Preventive Action
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The Organization determines actions to eliminate the causes of potential non-conformities in order
to prevent their occurrence. Extent of preventive actions depends on the impact of the potential
problems. The procedure addresses:
i. Identification of potential non-conformities and their causes.
ii. Determination and ensuring the Implementation of preventive action.
iii. Recording of results of action taken.
iv. Review of preventive action taken is effective and recorded.
i. Updating of Regulatory Requirements:
To ensure that the organization is in the knowledge of latest regulatory requirements and is being
regularly implemented via updating.
This procedure covers the process of updating legal & regulatory requirements related to
production, GMP standards and social requirements.
To ensure that all the legal and other requirements related to production operations, which are
applicable to the organization, are identified and current copy (if applicable) is available with the
organization
j. Product Recall:
After the quality defect has been identified and proved to be true beyond all possible doubts, the
Quality Assurance Manager brings the suggestion and the necessity of the recall to the notice of the
GM Plant Operations, the GM Plant Operations after evaluation immediately reports any potential or
actual recall to the Managing Director. The Managing Director has the final authority to grant a
recall of pharmaceutical product.
All the facts relating to the product quality, medical aspects, analytical reports, market impact,
possible legal action, and company’s reputation will be considered while taking the decision for a
recall of a pharmaceutical product.
k. Out of Specification Investigation:

To investigate the causes of the abnormal/failure test results to avoid the recurrence in future, as
well as to ensure that all the test results and each & every step are documented.
To describe the procedure to be followed to verify the abnormal failing test results, also to
investigate the causes of non conformance of test results. This procedure applies to all testing
performed by the Quality Control Department at every stage including in-process testing.
l. Reporting of Product Incidents:

To describe the procedure for observing, reporting production incidents and deviations/ critical
deviations from relevant Standard Operating Procedure (SOP)/ from Standard Specification, and the
corrective action to be taken in response of any incident/ deviation to rectify the problem and
preventive action to avoid the recurrence of the same type of problem in future.
m. Process Control:
i. Physical Laboratory
The Physical Laboratory working directly under the supervision of Quality Assurance Manager is
responsible for receiving, in-process and final inspection of products manufactured in the
Organization. (For details, refer to Physical Laboratory SOP’s)
ii. Environmental Monitoring

The Environmental Monitoring working directly under the supervision of Manager (Quality Control)
is responsible for Environmental Monitoring of Sterile and Non-sterile area to maintain the
controlled condition necessary for sterile and non-sterile production and testing.
iii. Monitoring of Environmental Condition:

Monitor the environmental condition (Temperature and Humidity) of the Sterile and Non- Sterile

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areas,
 Temperature of Cold Rooms 2.0 to 8.0 °C

 Warehouse Main Hall (General) 25 to 30 °C
 A. C. Room 20 to 25 °C
n. Calibration:
It is the responsibility of calibration to provide confidence in the measurement data, the measuring and
monitoring processes include confirmation that the devices are fit for use and are maintained to suitable
accuracy and accepted standards, as well as a means of identifying the status of the devices. All
measuring and monitoring equipment used for verification of products and for monitoring processes
including environment, safety and health monitoring are regularly calibrated and / or checked. A list of
such equipment is maintained.
The equipment is calibrated in accordance with an approved written calibration schedule. Calibration
standards are traceable to recognized national / international standards. The Organization provides the
basis for the standards used where no national standards or certified master standards exist.
Complete calibration records are documented and maintained. Records are evaluated periodically to
ascertain adequacy of calibration, inspection levels and calibration methods in use.
All measuring and test equipment are identified to indicate their calibration status. If it is not possible
to put an identification mark, the calibration status is recorded on an appropriate quality document,
which is traceable through an indexing system.
Where equipment is found to be defective or out of calibration, the results of the previous inspections
are reviewed and appropriate action is taken. Each equipment is safeguarded to avoid unauthorized
adjustments and calibration.
o. Validation:
It is the responsibility of Validation Section to validate any processes where the resulting output cannot
be readily or economically verified by subsequent monitoring, inspection or testing. This includes any
product where processing deficiencies may become apparent only after product is in use or the service
has been delivered. The process validation activities include:
i. Defined criteria for review and approval of processes.

ii. Approval of equipment and qualification of personnel.
iii. Use of specific methods and procedures.
iv. Requirements for records.
v. Re-validation
C.1.9.4 Audit Programmes:
Internal Audits are performed at least twice a year on each section of the company. Additional
unscheduled audits may be performed.
On the last week of December every year, the Internal Audit for the coming year is planned on yearly
basis by the Lead Auditor on Internal Audit Schedule. Internal Audit Schedule indicates the intended
date of audit and the area to be audited. The approved Internal Audit Schedule is then distributed to all
departments/sections.
 Quality Assurance Department

 Quality Control Department
 Production Department
 Supply Chain Department
 Human Resources Department.
 Engineering Department
 R&D Department
 IT Department
 Warehouse Department
Audit Execution:
At least a week before the planned internal audit date, the Lead Auditor finalizes the date and time of
Internal Audit. The Lead Auditor selects the appropriate Auditors from the Audit Team. The selected
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Auditors from the Audit Team must be independent of the area being audited. The Lead Auditor briefs
the Internal Auditors about the scope and purpose of the audit.
On the day of Audit, the Opening Meeting is scheduled to be held in the area to be audited. In the
Opening Meeting, the Auditors brief the scope, purpose, method and procedure for conducting Audit to
concerned auditee and clarifies details where needed.
The Audit is started by initialing reviewing, any outstanding noncompliance identified during past
audits, verifies the compliance of the documented system and regulatory and statutory requirements.
For verification the data and record generated as evidence of activities are examined for compliance of
the system.
The auditors may also verify from the personnel actually performing the tasks to ascertain whether they
understand the system.
The auditors may also observe the tasks being performed to verify the activities being performed as per
documented procedures.
The auditors may also assess, whether the product is meeting the customer’s requirements, and
Process Approach is being followed and environment is safe for working including housekeeping, sound
survey and machine safety checks.
The auditors verify the system and the process as per the Self-Inspection Checklist for compliance. The
Self-Inspection Checklist comprising of all applicable regulatory requirements is prepared by concerned
department head and approved by the Quality Assurance Manager.
When the auditors observe nonconformity in the system, all relevant information is examined carefully
and full details of nonconformity or deficiency are recorded.
The Auditor may also suggest improvements and simplification of system during the audit. It is the
responsibility of the auditee not to become defensive, as the internal audits are conducted for the
improvement and maintenance of the system.
Throughout the audit, observations made by the auditors are recorded on an Internal Audit Report.
After the completion of the Internal Audit, the auditors inform and discuss observations and
noncompliance identified during the audit with the auditee in the Closing Meeting held in the Quality
Assurance Manager office. After discussing all the discrepancies the Internal Audit Report is then
approved by the Management Representative. Non-Conformance Report (if any) are agreed to and
signed by the auditee in the closing meeting. Target dates are decided. The Quality Assurance Manager
may also advise the auditors.
After Approval, the audit report will be given to relevant departmental/sectional head/auditee.
b. Surveillance Audit:
The Surveillance Audit is conducted by the external auditors to verify the compliance of certified
standard requirements. The Surveillance Audit is normally conducted after every six months, additional
Surveillance Audits may also be conducted as per requirements. At least one month before the coming
Surveillance due date, the Management Representative contacts the external auditors, for the
finalization of Surveillance Audit date. After the finalization, the date is circulated to all departments /
sections.
The Management Representative organizes and facilitates in conducting the audit. The audit
observations (if any) are forwarded to management for necessary action.
c. Inspection by Regulatory Authorities:

The Organization is committed to comply the regulatory requirements. The Regulatory Authorities often
inspect the operations of the Plant as per their schedule to verify the implementation of the
requirements. The observations made by Regulatory Authorities are documented in their inspection
book maintained in the plant with their sign and stamp. These regulatory inspections serve as an
evidence for the compliance of regulatory requirements. The observations and recommendations are
carefully reviewed by all the concerned and necessary rectifications and procedures are adopted to
achieve the compliance.
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Any nonconformity identified during any of the audits mentioned above, or any suggestion or
improvements are rectified by initiating Corrective and Preventive Action Request by the Quality
Assurance Manager.
C.1.9.5 Release Procedure and Review of Results
a. Receive GRN/intimation to QAD for Test/Analysis from Warehouse/Production Department.

b. Collect sample from Warehouse/Production Department.
c. Analyze sample according to the relevant SOP.
d. If it meets the specifications it is released for next stage.
e. Trend analysis is also performed to show the consistency of quality
f. Give release on GRN/Intimation to QAD for Test/Analysis in case of Warehouse/Production
Department.
Give retest due date according to following program
i. After one Year Incase of Active Raw Material having Mfg. & Exp. Dates
ii. After two Year Incase of Inactive Raw Material having Mfg. & Exp. Dates
iii. After 6 months Incase of Inactive Raw Material with no Mfg./ Exp. Dates
g. Reject the Raw/Packaging materials if it does not meet standard specifications please refer to SOP
of Control of Non-Conformance.
h. After completion of Batch and audit of BMR by QAD, QAD sends “Released Sticker” for “Released for
Marketing” on the basis of Production Order.
i. After “Released for Marketing” QAD sends one copy of Production Order (MO & PT) to accounts
section while the other copy of PO is retained in BMR.
C.1.9.6 Vendor’s Qualification:
Qualification of Vendor ensures that the vendor under consideration is capable of supplying material
under required specification in time. The procedure for the vendor’s qualification applicable for those
vendor supplying Raw and Packaging Material. Following are prerequisite for Vendor’s qualification
a. Purchase Department receives samples along with Certificate of Analysis from new vendor or
the sample from approved vendor for the qualification of new Material.
b. Purchase Department hand over the samples to Quality Assurance Department.
i. In case of Raw Material, Quality Assurance Department submits the sample and the
Certificate of Analysis to Quality Control Department along with Technical Information Sheet.
iii. In case of Packaging Material, Quality Assurance Department analyzes the sample by itself.
c. After Analysis, Quality Control Department submits the results to Quality Assurance Department on
Vendor Sample Test Report, whereas for the Packaging Material, the Quality Assurance prepares the
Vendor Sample Test Report by itself.
d. Quality Assurance Department analyzes the results and decides whether the sample is accepted or
rejected as Approving authority.
e. Procedure 1 to 4 is repeated on two different lots of raw materials.
f. Quality Assurance compiles a comparative data of the received material against the alternative
approved material or the material from approved vendor.
g. For the vendor qualification Quality Assurance may conduct a Vendor Audit, for this purpose Quality
Assurance prepares Vendor’s Audit Schedule and a checklist for audit.
h. For Vendor’s Qualification it is mandatory for vendors to submit
i. Certificate of Analysis & Quality Drawings.

ii. Material Safety Data Sheet.
iii. Brief description/Flow diagram of Manufacturing Procedure and Testing Procedure
iv. Stability Data to support the shelf life of the product/ Material.
On the basis of the results of the material (comparative Data), the requirement for the qualification and
the vendor’s audit report, it is decided either the vendor qualifies or not. In case of foreign suppliers,
the condition of Vendor’s audit may be relaxed.

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If the vendor qualifies the vendor’s qualification criteria, the Quality Assurance Manager recommends
adding the said vendor in the WELLBORNE (Pvt.) Limited Approved supplier List.
C.1.9.7 Suppliers of all the critical or non critical starting and packaging material are assessed at the
beginning of source qualification by
 Vendor Evaluation Form

 Vendor Audit Checklist
 Visit of Vendors keeping in view of ISO guidelines and other regulatory requirements.

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2.0 PERSONNEL
2.1 ORGANOGRAM
Chief Executive
Director
Operations
GM Plant GM Marketing & Sales
Manager Warehouse Production Manager QA Manager Admin/Accounts

QC Manager Manager Distribution Distribution Finance
Manager Manager Manager
DM PD DM QA DM QC Officer
RMS Incharge PMS Incharge FGS Incharge
AM AM
S. Analyst S.
Microbiologist
Pharmacist QAI/Pharmacist
Analyst Microbiologist
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2.2 QUALIFICATIONS, EXPERIENCE AND RESPONSIBILITIES OF KEY PERSONNEL

Refer to section 1.7 List of technical Staff
C.2.3 Basic and in-house training
C 2.3.1: Training
Training requirement of personnel is assessed by applying various techniques. Major objective of
training is given to enhance general as well as specific knowledge, abilities, and skills required for
effective and efficient performance of tasks.
Three types of analysis are being carried out to examined and find any discrepancies between
desired and actual performance.
a. Organization Analysis
It concentrates on specific training required to meet the organizational objective to overcome the
weaknesses brought out during internal audit and subsequent requirement of corrective and
preventive action.
b. Job Analysis
It concentrates on what should be taught to enable a trainee to perform his/her job satisfactorily.
The criteria for this analysis are:
i. Conclusion of organizational analysis report.
ii. Previous job analysis result.
iii. Specific knowledge required for specific or group activity.
iv. Implementation of job analysis.
v. Evaluation of performance standards etc.
c. Person Analysis
This is done to select suitable individuals who can benefit from training. The HR Manager evaluates
the performance of individuals/group from performance appraisal form and compares with the
expected performance standards as identified in the job analysis form.
C 2.3.2 Training Schedule

We have comprehensive training schedules as follows:
a. Monthly training schedule for employees.
b. Bi-Annual training schedule for officers.
c. Bi-Annual Emergency training schedule.
The Bi-Annual training plan may include external as well as in-house training sessions like
workshop, seminars, lectures, group discussions, presentations, on job training etc.
Bi-Annual training plan is circulated to all departments by the last week of December, every year.
C 2.3.3: Internal Training

Training section with the coordination of relevant subject specialist develops the training program.
At the end of course, training feedback form is circulated to all the participants to collect the
information that learning objectives are being achieved and whether the trainees are satisfied with
the training.
Course attendance sheet is filled by the concerned department head and submitted to HR
Department. HR Department records the training course in training record of individual’s personal
file.
C 2.3.4 Re-Training need is identified through following activities:

a. Feedback form.
b. Job Analysis.
c. Internal Audits.
d. Organization Analysis.
e. Personal Analysis through Appraisal.
C 2.3.5 Training Records

a. Course Attendance Sheet.
b. Monthly Training Schedule.
c. Training Feed Back Form.
d. Bi-Annual Training Plan.
e. Job Analysis Form.
f. Emergency Training Schedule.
C 2.4 Health Requirement for the personnel engaged in Production:

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Plant has employed a full time medical officer who is responsible for routine medical examination of
all employees on Bi-Annual basis. The production staff is checked on quarterly basis. Before an
employee is inducted in service, he goes through detailed medical checkup which includes the
blood CP, urine examination, X-Ray etc. All employees are examined for hepatitis and vaccinated
against Hepatitis B.. In case sickness is beyond three days, the medical officer examines the
patient and he/she is allowed to resume duty after ascertaining that he/she is medically fit. The
employees working in sterile area are regularly monitored for their health.
C 2.5 Personnel Hygiene requirement including clothing:

Continuous training is imparted on the subject of personal hygiene. Every worker is issued with
three pairs of uniform which are washed regularly in a laundry. Sufficient number of change rooms,
rest rooms has been provided and there is an elaborate arrangement of housekeeping. Dresses of
sterile area are handled with extreme care. There are elaborate instructions (SOPs) on the subject
of hygiene and sanitation.
3.0 PREMISES AND EQUIPMENT

Premises:
3.1. DESCRIPTION OF MANUFACTURING AREAS
3.1.1 Plan of the Facility is discussed as under
3.1.2 This Site of production building:
Pharma Health Division: Drug products of General Pharma Division are manufactured and
packaged in this building, with separate processing areas for Solids, Liquids and semi solids
& Packing along with the storage of Raw materials, Packaging materials and Finished
goods.
A self-contained facility for Cephalosporin is provided inside the production area, with separate
man and material movement areas.
3.2 NATURE OF CONSTRUCTION AND FINISHES

The facility is made of concrete structure, with firm and smooth surfaces, properly coved corners.
All fittings and fixtures are flushed. Use of wood and asbestos is avoided in the processing areas.
As per the need of the process, different kinds of flooring have been provided e.g.
 Floor with coving
 Polished Kota Stone flooring
 Material of construction of the doors and windows is suitably painted aluminium with glass,
designed so as to have a minimum number of joints and bends.
3.3 BRIEF DESCRIPTION OF VENTILATION SYSTEM

The requirement of temperature, humidity and type of air is pre-defined as per the process. Each
area is provided according to its environmental requirements, with suitable HVAC Air Handling
System.
3.3 SPECIFICATION OF AIR SUPPLY:
Environmental Conditions are specified in the Room program charts and qualified as per area
requirements in the HVAC Design Qualification. A written SOP is maintained for AHU.
3.4 BRIEF DESCRIPTION OF WATER SYSTEM

C.3.5 Water System
The water processing system comprises on following
1 Sand Filter:
A vessel of size 54-inch dia, having 4 type gravel filtration material beds, with backwash
system. Media filter are designed to backwash when they become loaded with site or
other particles. This backwash step also helps to reduce biological growth in the media.
The highly spherical shape of UNCRUSHED GRAVEL promotes good flow. Being low in
soluble impurities, it will maintain the quality of the treated water. The sand filter

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removing suspended solid at sizes as small as 5 to 10 micron, according to WHO

standards.
Physical properties
 Color Light tan to reddish brown.
 Density 100 lbs/ft3
 Effective size 0.45-0.55mm
 Uniformity coefficient 1.6 or less
 Acid solubility 0.3-1.6%
 Specific gravity 2.65-2.75
2 Activated carbon filter:
A vessel of size 54 inch length x 10 inch dia, having gravel filtration material beds and
coconut –based activated carbon, with backwash system. Granular activated carbon
constitutes an excellent filtration media, having high density with a balanced pore
structure for more efficient absorption. Activated carbon has successful in the absorption
of orthochlorophenol and the removal of free chlorine from water suppliers. The end
product is clean, fresh water, with no objectionable taste characteristics.
Activated carbon requires only periodic backwashing to eliminate accumulated
suspended matter and to re-grade the filter bed. Carbon filter are also effective for total
organic carbon reduction. Organic contaminates include pesticides, herbicides, decayed
plant, animal tissue and gasoline etc. activated carbon has extremely high capacity for
removal of taste, odor, and color. Activated carbon will import a high polish to the
filtered water.
 Color Black
 Form Granular
 Mesh size 20 x 40
 Density 33lb/ ft3
 Water soluble ash less than 0.5%
 Iodine # 800
 Abrasion 75min
 Meets American water
 Works association standard B604-74
3 Water softener:
A vessel of size 54 inch length x 10 inch dia, and one bring tank. The water softener is
used to remove hardness (temporary and permanent) the water, replacing these with
sodium ions. The water should be softened to below 5mg/L hardness, this is necessary
to avoid scaling of the RO membrane at the higher pH levels. This is a patented filtration
process utilizing beads coated with a cationic polymer that is capable of removing very
small charged particles.
Regeneration:
When the ion-exchange medium has been saturated with calcium salts it must be
regenerated. For this NaCl solution is passed through the icon-exchange media. The
frequency of regeneration requires depends on the hardness of the water and water
consumption.
4 Water polisher:
It consists of one 10 inch standard housing with polypropylene cartridge. It will remove
the residual and suspended particles finally down to 1 micron. After passing through
water gives sprinkling look.

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Reverse osmosis:
Reverse osmosis is a separation process in which dissolved ions, heavy molecular weight
compounds, and particulate matter are remove from a liquid by applying pressure to the
concentrate solution (it must be greater than the osmotic pressure difference) the water
flow is reversed. Reverse osmosis is computer designed utilizing the latest update
element date form all major element manufacturers, and minimize the number of dead
lags or stagnant area.
Bacterial reduction by RO (Reverse Osmosis)

If installed and operated correctly, RO member elements should provide a 3 –log
reduction (99.09%) in bacteria and other organics with a molecular weight of 1250
Daltons or gr3eater.
Membrane process:
Membrane accomplish a great deal in water purification system, including ion removal,
particulate removal, removal of organic compounds, organisms removal, preferred are
sanitary design polyamide (PA)membrane that reject more than 99.09% NaCl and have
stainless steel casing.
Reverse osmosis membrane-pressure vessel assembly:

 Spiral wound, polyamide, thin film composites reverse osmosis membrane
representing state of the art technology.
 High water purity with membrane rejection of 90%.
 Membrane is designed for long life with easy cleaning.
 Membrane is enclosed in pressure vessel with ratings to 600 psi.
 Easy to change end plug assembly with long life and durability.
 Forged high pressure fittings.
 High pressure components rated at 2 time’s maximum operating pressure for
safety.
R.O Specifications:
1. System feed pressure 2.5 bar
2. System maximum operating pressure 1250-200 psi
3. Type of membrane material Polyamide
4. Membrane casing Stainless steel
5. Membrane Imported (USA made)
6. Size of membrane 4-inch dia x 40-inch length
7. Type of pumps Multistage Stainless steel
8. Minimum required pressure for pump 2 bar
Electric Panel:
1. Low pressure auto control
2. Conductivity Meter
3. Pressure Gauge for long life.
4. System fully auto control (Feeding to final output)
5. Skid Mounted (MS frame)
(5) Ion-exchange polisher:

The ion exchange polisher is composed of cation exchange & anion exchange resin of
high purity in separate vessels. All cautions in water like Calcium (Ca) Magnesium (Mg) Iron
(Fe) Copper (Cu) etc are removed by cation exchange resin.
2R-SO3H+Ca+2  (R-SO3)2Ca + 2H+1 ………………. (1)
While anions present in Water chlorides (CI-1), Sulphates (SO4-2), Carbonates (CO3-2) etc are
removed by anion exchange resin.
R.N-OH + CI-1  R.N-CI + -1OH...……………….. (2)

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WATER SPECIFICATIONS AS PER USP
Following are the testing Protocols for water to be used for various purposes i.e. Water for
Washing, Water for Injection, Water for formulation of Syrup/ suspension & Water for
Chemical analysis.
Water for Chemical Analysis
S.No. Testing Parameters Limits

1 Physical Appearance Clear Colorless water
2 Particulate Matter None
3 pH 5-7
4 Calcium No Turbidity
5 Chlorides No Opalescence
6 Sulphate No Turbidity
7 Hardness Should be absent
8 Total Dissolved NMT 0.001%
9 Oxidizable Solvents Pink color does not completely disappear
C. 3.5.6
The following chemical, Conductivity and microbiological tests are being performed for water
produced.
1) Chloride Limits: NIL ; Distilled water.

NMT 0.5ppm; Distilled water.
NIL; Water for injection.
2) Sulphate Limits: NIL ; R.O. water.

NMT 0.5ppm ; Distilled water.
NIL ; Water for injection.
3) Hardness Limits: NIL ; R.O. water.
NIL ; Distilled water.
NIL ; Water for injection.
4) pH Limits: 5.0 – 7.0: R.O. water.

5.0 – 7.0: Distilled water.
5.0 – 7.0: Water for injection.
5) Residue on Evaporation (ROE); Limits: NMT 0.0003% Water for injection.
6) Oxidisable substances; Limits: Should not be present.
7) Conductivity: R.O. water 1.3 µs p/cm-1 & Distilled water 1.3 µs p/cm-1 at 25oC
Water for Injection NMT 1.3 µs p/cm-1
1) Bio-burden check; Limits: NMT 10Cfu / 100ml: Dist. Water.

Sterile (0 Cfu / 100ml): Water for injection.
E. coli (U.S.P. pathogen) should be absent in
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Dist. water & water for injection.
2) Bacterial Endotoxin (LAL) Test.

Limits: NMT 0.25 EU /ml
Water for injection only.
C.3.5.7 The Sampling Points and Frequency of sampling
Sampling Point
1. RO Plant
Frequency On daily basis
C.3.6 Maintenance and service of the Air Handling and Water System
Maintenance and serving of air handling and water system is carried out according to Annual
Maintenance Plan checked out at the end of year. All air conditioners and water filters are regularly
cleaned and record maintained. There are written SOPs laying down detailed procedures and
guidelines. Efforts are made not to effect production during maintenance and there is no chance of
effecting product quality during maintenance.
3.5 MAINTENANCE OF PREMISES

Planned preventive maintenance programmed is followed as per SOP, Which describes in detail the
procedure for the manufacturing unit covering the schedule of maintenance and servicing of
processing areas, equipment and utilities. Maintenance schedule include daily, weekly, fortnightly
and monthly checks and corrective action as per requirement.
SOP covers Preventive and Break down Maintenance of area, equipment and utilities as per
calendar and on written intimation from concerned department in charge in the prescribed format.
Records of preventive maintenance carried out by the technician and by external agencies, is kept
by Engineering department. Machine History Card is filled for major maintenance jobs and
modifications, if any.
Maintenance is carried out during weekly of days or during plant / area shut down. So that product
quality remains unaffected.
The critical findings from the maintenance reports are made known to the concerned people for
timely action as per requirement.
3.6 BRIEF DESCRIPTION OF MAJOR PRODUCTION AND LABORATORY EQUIPMENT

All e q u i p m e n t s h a v e b e e n a l l o t t e d d i s t i n c t i v e I d e n t i f i c a t i o n nu mb e r s .
Records for the history of maintenance of critical equipment are kept in the Engineering
department.
3.6.1 Machine parts in contact with the drugs products during processing are made of SS.
3.6.2 The material of construction for equipment is SS.
3.6.3 The equipment are designed suitable to operate, clean and maintain, and appropriately
located in the operational areas for ease of operation, cleaning and maintenance. The
equipment capacity is suited to the batch sizes processed. The equipment are arranged
to permit a logical flow of materials.

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3.7.1 (A) LIST OF CRITICAL EQUIPMENT IN PRODUCTION DEPARTMENTS

List of Machine
Cephalosporin (STERILE)
Sr.# Equipment Name Type & Capacity Identification
1 Ambica Filling Machine 36000/8 Hrs. INDIA
2 Vial Sealing Machine 72000/ 8 Hrs. CHINA
3 LFH Fitted Trolley 6-Trays/ Load. ?
4 Dry Heat Sterilizer 16000 Vials/ Load. LOCAL
5 Autoclave 18/36” LOCAL
6 Vial Washing Machine 20000/ 8 Hrs. LOCAL
Cephalosporin Capsule Filling Line.

1 Double Cone Mixer 100kg LOCAL
2 Semi-Automatic Capsule Filling 10000/ Hrs CHINA
Machine
3 Capsule Sorting Machine 100000/ 8 Hrs. IMPORTED
Cephalosporin Powder Filling Line.

1 Sugar Crushing Machine 200kg/ Hr. LOCAL
2 Cone Mixer S.S 100kg DO
3 Dry Powder Filling Machine 8500/ 8 Hrs DO
4 Bottle Sealing Machine 9000/ 8 Hrs. DO
5 Bottle Blowing Machine As per requirement DO
6 Tray Dryer 30 Trays DO
General Capsule Filling Line.

1 Semi-Automatic Capsule Filling 10000/ Hrs CHINA
Machine
General Tablet Section.

1 Ribbon Mixer 100Kg LOCAL
2 Double Cone Mixer 100Kg LOCAL
3 Rotary Granulator 100Kg LOCAL
4 Oscillating Granulator 50Kg LOCAL
5 Fluid Bed Dryer 30Kg/Local LOCAL
6 Tray Dryer 100Kg LOCAL
7 Tablet Compression Machine vZP- 25000 Tabs/Hr. CHINA
17
8 Coating Pan-1 50Kg LOCAL
9 Coating Pan-2 10Kg LOCAL
10 Alu-Alu Blistering Machine -1 30 Strokes/min CHINA
11 Tablet Compression Machine ZP-25 40000 Tabs/Hr. CHINA
12 Solution Mixer 20 L LOCAL
Utility Description Capacity Manufacturer Origin

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HVAC- System
Air Handling unit
 Cephalosporin Sterile 13 Ton Pakistan
 Cephalosporin Capsule Line 6 Ton Pakistan
 Cephalosporin Powder Line 6.5 Ton Pakistan
 Cephalosporin Blistering Area 2 Ton Pakistan
 General Tablet 6.5 Ton Pakistan
 Syrup Manufacturing Section 8 Ton Pakistan
 G.T (Mixing Section) 5 Ton Pakistan
 G.T (Drying Section) 6 Ton Pakistan
 G.T & Ceph (Main Corridors) 10 Ton Pakistan
Compressor Large 8 Bar Not Oil Free
Compressor Small 6 Bar Not Oil Free
Vacuum Pump 2 No’s Pakistan
Drilling Machine 1 No’s Pakistan
Grinding Machine 1 No’s Pakistan
Sheet Cutter 1 No’s Pakistan
Welding Plant 1 No’s Pakistan
Water Pump (Submersible etc) 3 No’s 5 No’s Pakistan
Lyophilized Area 6.5 Ton Pakistan
Gen-Washing (Amp+Vial) 4 Ton Pakistan
Amp-Filling Area 6 Ton Pakistan
Amp-Buffers 3 Ton Pakistan
Q.C Micro Lab 4 Ton Pakistan
LYOPHOLIZED SECION.
1 Manual Filling Machine 20000/ 8 Hrs. LOCAL
2 Manual Sealing Machine 6500/ 8 Hrs. LOCAL
3 LFH Fitted Trolley 6-Trays/ Load ?
4 Dry Heat Sterilizer 20000 Vials/Load LOCAL
6 Vial Washing Machine 15000/ 8 Hrs LOCAL
LIQUID INJECTION SECION.

1 Formulation Tank -1 50 L LOCAL
2 Formulation Tank -2 250 L LOCAL
3 Propeller 300 rev/min. LOCAL
4 Filteration Assembly As per requirement LOCAL
5 Pyrex Glass jar 2x20 L ENGLAND
6 Dry Heat Sterilizer 50000 Amp/Load LOCAL
8 Ampoule Washing Machine 50000/ 8 Hrs LOCAL
9 4.Head Ampoule Filling Machine 40000/ 8 Hrs CHINA
10 2-Head Ampoule Filling Machine 20000/ 8 Hrs LOCAL
11 PVC Blister Machine 25 Stroke/Min CHINA

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List of Miscellaneous item in Production Department

1 Hygrometer Zeal England
3 Digital Weighing Balance
4 Digital Weighing Balance
6 Dehumidfier (General Tablet) 90L/Hr Sabro
7 Dehumidfier (Cephalosporin) 90L/Hr Sabro
8 Dehumidfier (RMS Ceph) 60L/Hr Local
9 Dehumidfier (RMS General) 25L/Hr Local
10 Dust Collector (Miscellaneous)
11 Insect Killers (Different sets)
12 Induction Seal Machine (Manual)
13 Bottle Blowing Machine (Syrup)
14 Dispensing Hood
15 Sampling Hood
16 Split Air-Conditioners
17 Window Air-Conditioners
18 Hand Pallet Fork Lifter
19 Working in Engineering Dept.
20 Working in Production Area
21 Air Curtains
22 Air Handling System (Cleaning)
23 Air Handling Unit (Operation)
24 Air Handling Unit SOP.
25 Photocopier
26 Fire Extinguisher

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3.8 MAINTENANCE OF EQUIPMENT
3.8.1 The equipment are maintained and serviced by in-house Engineering department and
also by external approved agencies for servicing of weighing balances and some
analytical instruments.
3.8.2 Services of external agencies are undertaken on contractual agreement between the
company and the concerned agency. Biannual Maintenance Contract (BAMC) is signed for
critical process equipment, analytical instruments and utilities.
3.8.3 Maintenance work is carried out without affecting the product quality by scheduling such
operations on weekly off days and after working hours. Care is taken to isolate of
equipment from materials being processed followed by post maintenance cleaning and
lubrication.
3.8.4 Record of routine and breakdown maintenance is kept in engineering department along
with records of planned preventive maintenance. Machine history card is updated on
completion of maintenance work.
3.8.5 During in-house servicing of process equipment by the Engineering department,

observations are notified to the concerned section regarding the nature of service
carried out and further precautions to be taken.
C.3.9 Qualification, Validation and Calibration.
C.3.9.1 General Policy

The general policy is to validate,
 Process (Concurrent and Retrospective Validation)
 Analytical Method Validation
 Validations of Cleaning Procedures
 Qualification of Machines and Equipment
 Validation of Systems (e.g. HVAC System, Distilled Water, R.O. Water System etc.
C.3.9.2 Revalidation Policy:
Periodic Revalidation:
Once a system has been validated, it is considered to be in a state of control. So as long as all
conditions and control parameters remain unchanged, the system continues in its validation state.
To assess the validity of the system there should be a periodic revalidation program by the
application of retrospective validation approach only in Process & Method Validation.
Activity Periodic Revalidation
Concurrent Validation After Five Years
Retrospective Validation After four Years
Method Validation After Five Years
Machine/ Equipment Validation After Five Years
Cleaning Validation After Four Years

System Validation (e.g. HVAC System, Distilled/
After Three Years
Deionized Water System, Cold Chain System, etc.)
The periodic revalidation program is as under,
Revalidation after Change:
A formal monitoring system which review proposed or actual changes that might affect the
validated status and take preventive and corrective action to ensure that the system retains its
validated state of control.

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Revalidation of the System, equipment, Process, Procedure, Method etc. may be necessary
depending on the significance of change.
No changes should be made in any validated equipment/ system/ testing methods/ processes
without formal review and approval via change control procedure
C.3.9.3 Outline of Process Validation

The Process Validation is intended to prove through documented evidence that the current
manufacturing process as described in the relevant BPS is under control and capable of producing
reproducible, reliable and consistent quality product.
To describe the phases of validation dealing with the sampling and testing at various stages of
critical processes of manufacturing, e.g., Mixing and Compression to ensure that the final mixing
provides uniform distribution of active ingredient in the product.
C.3.9.4 System for release of development and validation batches.

The batches under development and validation are released for sale or supply on the basis of
satisfactory results of Accelerated Stability Studies.
3.9.5 Computer Validation

Computer validation process is an activity which is performed in factory in close coordination of QA
department.
Computer validation comprises of Hardware and Software validation.
Hardware Validation
The hardware which is purchased in factory is thoroughly validated to ensure that it is compatible
with corresponding Software used in factory.
Software Validation
In house developed Software are thoroughly validated by insertion of Input data & then results are
validated by the concerned department. This validation is performed using Black Box /White Box
testing techniques. Separate Flow charts of each automated activity is maintained to ensure
smooth flow of data.
C.3.9.6 Calibration Policy and Records:

Calibration is the comparison of a measurement standard or instrument of known accuracy with
another standard or instrument of unknown accuracy to detect, correlate, and eliminate by
adjustment any variation in the accuracy of the item being compared
There is a well established Calibration Section, which is regularly performing calibration of all the
Inspection, Measuring and Test Equipment by using the Master Calibrators.
First the Calibration Control list is developed, from this list Monthly Calibration Scheduled is
prepared, all the Calibration results are compiled in Calibration Certificates and the Calibrated
equipment is pasted with Calibration Slip. If the Calibration results do not comply with the
specifications the equipment is then pasted with defective Equipment Slip and Engineering Work
Order is raised for maintenance. After maintenance the Equipment is recalibrated by the Calibration
Section and allowed for use.
C.3.10 Sanitation:
There are written specifications and well defined procedures are available for cleaning and cleaning
agents.
C.3.10.4 Cleaning in sterile area:

The cleaning in sterile area is monitored. The disinfectants dilutions are checked for their efficacy
and are checked qualitatively for bio-burden. The surface of aseptic filling machine, filling room,
walls and floors are checked quantitatively for bio-burden using Rodac contact plates.
Different disinfectants used in sterile area for disinfections are:
 Phenol 5%
 IPA 70%
 Dettol
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 Broad spec. 0.4%

All these disinfectants are freshly prepared and are rotated weekly to avoid the production of
resistant forms of bacteria. In non-sterile area, filling machines after washing are tested for
microbial contamination
through sterile swabbing. 2 ½" x 2 ½" area is checked as a representative sample surface. Pour
plate method is used to check the microbial count.
Traces of different active materials are checked using the respective active solvent with a clean
swab. 2 ½" x 2 ½" are checked and the traces of the active are checked as per active assay
method.
4.0 DOCUMENTATION
C.4. Documentation:
C.4.1. Arrangement for the preparation, revision and distribution of necessary

documentation.
Adequate arrangements for the preparation, revision and distribution of necessary documentation
are available for different activities.
C.4.1. Description of the Documentation System.

Documentation System covers the operation for preparing, issuing, receiving and controlling the
Quality System Documents and identifying, collecting, storing, maintaining and disposition of
Quality System Records. To ensure that all the system documents are reviewed and approve prior
to issue and are available at the appropriate location and all records are retained and disposed off
as per system.
C.4.1. Responsibility for the preparation, revision and distribution of documents.

All the controlled documents are prepared by the section in-charge and reviewed by the relevant
departmental head; the Quality Assurance Manager signs all the documents as approving authority
and finally all the documents are signed by the Plant Manager as authorizing authority. The same
procedure is followed in case of new revision of the documents. After signing the documents,
required number of copies of documents is made according to the distribution list by
Documentation and Record Control Section.
C.4.1.3 Where are the master documents stored?

The Mater Copies of all the controlled documents are securely stored in Documentation and Record
Control Section.
C.4.1.4 Standard format and instructions for the preparation of the documents.
There is an approved format for the preparation of all the control documents, e.g. the approved
format for the SOP’s is,
 Header and Footer of the document
 Purpose of the document
 Scope of the document
 Terms and definitions
 Responsibilities
 Environment, Safety and Health precautions
 Procedure
 Reference
 Record
 History and
 Distribution List.
SOP for Documentation and Record Control (WELLBORNE (PVT.) contains instructions for “How to
write an SOP”
There as documents for Master Formula, Raw Material and Packaging Component Specifications
as well as Sop’s for different processes including Packaging, Analytical Method and QA Release
Procedure are also available.

WB/SMF/QF/001
C.4.1.5 How is the documentation controlled?

Record Officer maintains the Document Cards for the effective control of the documents.
C.4.1.6For how long is documents kept?

Documents like Batch Processing Records are retained for at least one year after the expiry date of
the finished product.
All other record generated in the organization are retained for the period of three years. Whereas
the Quality System Obsolete Documents till the next revision of the specified document becomes
obsolete.
C.4.1. Arrangements for electronic or microfilmed records.

Different types of documents as given below are also available on Intranet in “Read Only” files.
C.1.4.2 Other documents related to product Quality

Comprehensive Product Manual generated by the R&D Department is being used.
All the following documents are available and are effectively in use.
C.4.2.1 Equipment Specifications

C.4.2.2 Specification for disposables i.e. cleaning materials
C.4.2.3 Standard Operating Procedures
C.4.2.4 Quality Control Procedures
C.4.2.5 Training Procedures
C.4.2.6 Computer Program Specifications
C.4.2.7 Documentation Control of process deviation
C.4.2.8 Calibration and test documents
C.4.2.9 Validation documents.
C.4.2.10 Reconciliation of batches of raw materials, bulk product, major packaging

components I.e. product contact and printed material.
All types of above mentioned reconciliations are being performed in the BPS (Batch Processing
Sheet) of the relevant product
C.4.3 Additional Document.

1. Planned Preventive Maintenance Records
2. Medical Checkup and Health Records
3. Pest and Rodent Control Records.
5.1 BRIEF DESCRIPTION OF PRODUCTION OPERATIONS
Production operations are carried out under the supervision of qualified and experienced
technical staff, graduates / postgraduates in Pharmacy / Chemistry with experience in
pharmaceutical production. Supervisory staff is trained to be always vigilant during the
processing activities. In- process Quality Control monitors the batch processing. The BMR is
recorded as the batch manufacturing progresses and reviewed by QA at every stage. Batch

WB/SMF/QF/001
manufacturing is carried out as per the respective BMR. Batch reconciliation is done at critical
stages of manufacturing and packaging.
C.5.2 Arrangement for handling of starting materials, packaging materials, bulk and
finished products including sampling, quarantine, release and storage.
When the starting Material (Raw and Packaging Material) is unloaded in Warehouse the weight,
Batch No. Mfg. and Expiry date are checked in case of Raw Material only.
The material is then labeled with Identification Sticker and is placed in quarantine area.
Quality Assurance Department is intimated through GRN from Warehouse. QAI collects the sample
according to Sampling Plan/SOP. The sample is analyzed according to relevant SOP. If it meets the
specification, it released for the next stage. Released Sticker per container is sent along with filled
GRN to Warehouse. If it does not comply the specification it is rejected through NCR (Non-
Conforming Report). After completion of batch, BPR is audited by the QAD and Released Sticker for
Released for Marketing is sent on the basis of Production Order
Dispensing of the Raw Material is done by Warehouse Pharmacist in presence of Production
Pharmacist and QAI. Before Dispensing Calibration of the balance is checked. Material is dispensed
according to Material Requisition/ Manufacturing Order. After dispensing the information are
entered into the Bin Cars and computer Software.

WB/SMF/QF/001
FLOW CHART OF TABLET SECTION
PRODUCTION DEPARTMENT
Issue Requisition Issue Requisition
RAW MATERIAL STORE PACKING MATERIAL STORE
QA Line
Clearance Sorting (Packing
Material)
QA Line
MIXING Clearance
Sorting (Tablets) Blistering

GRANULATION
QA Line
DRYING Sorting/ (Blisters) Clearance
QA Line
Clearance
GRANULATION
PACKING
LUBRICATION
Retained
Sample
QA/QC
Finished Goods
Store
COMPRESSION
QA/QC
COATING
QA/QC

WB/SMF/QF/001
FLOW CHART OF CAPSULE SECTION
Sorting (Packing
QA Line
Clearance Material)
QA Line
Clearance
MIXING Sorting/Polishing Blistering
QA Line
Sorting/(Blisters) Clearance
LUBRICATION
QA Line
Clearance
QA/QC
PACKING
Retained
Sample
Finished Goods
Store
WB/SMF/QF/001
FLOW CHART OF DRY SUSPENSION SECTION

(CEPH)
Issue Issue
Requisition (M.O) Requisition (P.O)
QA Line QA Line
Clearance Clearance
SIEVING PRINTING
QA Line
MIXING Clearance
QA/QC
LABELING
FILLING
PACKING
Retained
SEALING Sample
Finished Goods
Store
WB/SMF/QF/001
FLOW CHART OF LIQUID INJECTION
QA Line QA Line
Clearance Clearance
WASHING PRINTING
QA Line
DRY HEAT Clearance
STERILIZATION
LABELING
AUTOCLAVATION
QA Line
Clearance
MIXING
QA/QC PACKING
Retained
Sample
FILTERATION
Finished Goods
Store
FILLING
OPTICAL CHECK

WB/SMF/QF/001
FLOW CHART OF DRY INJECTION

CEPH
PROCUCTION DEPARTMENT
Raw Material Racking Material

Store Store
QA Line
Clearance
QA Line
Clearance
PRINTING
QA Line
Clearance
QA/QC
LABELING
FILLING
PACKING
Retained
Samples
SEALING
Finished
Goods Store
Identification of the Suppliers Lot No. with company’s Lot No.

WB/SMF/QF/001
After receiving the consignments of active and inactive Raw material, the Warehouse assigns the
consignments the internal Lot No. for traceability purpose.
Sampling Plan:
i. Receive Goods Receiving Note (GRN) from Warehouse on receipt of Raw Material.
ii. Physically inspect the consignment for manufacturer’s identification i.e. complete name of
item, Lot/Batch No., Mfg. and Exp. Date. Inspect each container for its condition, and check
that seals are intact, and enter the observation of physical inspection in “Physical Examination
of Incoming Raw Material” Performa.
iii. Sample each lot/ Batch individually if the shipment consists of material manufactured in
several batches or lots.
 For general raw material, use under root of the total number of containers in the lot received and
make a common pool. However, in case of active raw materials, sample the lot according to
MIL STD 105 E level II.
 For those requiring microbiological examination use under root plus one.
x= n +1
Lets: “n” is the No. of Container/Packs.
(Increase the value of “X” to next higher integer)
iv. Sample the Sterile Bulk Material in Sterile area. (All precautions for sterile area operations
must be practiced).
v. Draw the samples in dispensing room duly label & hand over to Q.C for testing.
vi. To avoid any chance of contamination due to mishandling, wear Lab. coat, cap, mask and
disposable gloves.
vii. Paste the “Under Examination sticker” to each container from which the sample has been
taken, bearing Item Name, Lot/Batch No., GRN No., quantity, No. of container/Packs, Pack
Size, Name of the Sampler and time of the sample taken.
viii. The quantity of the sample is dependent upon the requirement of the test /analysis. (Refer to
testing material requirement).
a. For General Raw Materials

Case Opening Table for Sample Withdraw ( Table # 1)
Value of x No. of Container / Packs Value of x No. of Container / Packs
2 Up to 4 26 626-676
3 5-9 27 677-729
4 10-16 28 730-784
5 17-25 29 785-841
6 26-36 30 842-900
7 37-49 31 901-961
8 50-64 32 962-1024
9 65-81 33 1025-1089
10 82-100 34 1090-1156
11 101-121 35 1157-1225
12 122-144 36 1226-1296
13 145-169 37 1297-1369
14 170-196 39 1370-1521
15 197-225 41 1522-1681
16 226-256 43 1682-1849
17 257-289 45 1850-2025
18 290-324 47 2026-2209
19 325-361 49 2210-2401
20 362-400 51 2402-2601
21 401-441 53 2602-2809
22 442-484 55 2810-3025
23 485-529 57 3026-3249
24 530-576 59 3250-3481
b. For Active Raw Materials (Inspection Level II – Normal Sampling Plan)

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Table # 2
No. of Container / Packs Sample Size
2-8 2
9-15 3
16-25 5
26-50 8
51-90 13
91-150 20
151-280 32
281-500 50
501-1200 80
1201-3200 125
3201-10000 200
10001-35000 315
35001-150000 500
150001-500000 800
The company has quarantine, released and rejected system in place for material & products. These
areas are completely segregated and are also identified by different colors.
The status Labeling of all the stages material and products being performed by the Quality
Assurance Department.
The Material for manufacturing and packaging purpose are issued by the Warehouse Officer in
presence of Production Officer for receiving the material and QA Officer for witness the issuance of
the material.
To issue the releases at every stage in production as a documentary evidence of in-process
control & authorization to proceed for subsequent process. The releases are issued according to
following procedure.
j. Receive GRN/intimation to QAD for Test/Analysis from Warehouse/Production Department.
k. Collect sample from Warehouse/Production Department.
l. Analyze sample according to the relevant SOP.
m. If it meets the specifications it is released for next stage.
n. Give release on GRN/Intimation to QAD for Test/Analysis in case of Warehouse/Production
Department.
Reject the Raw/Packaging materials if it does not meet standard specifications.
o. After completion of Batch and audit of BPR by QAD, QAD sends “Released Sticker” for “Released
for Marketing” on the basis of Production Order.
p. After “Released for Marketing” QAD sends one copy of Production Order (MO & PT) to accounts
section while the other copy of PO is retained in BPR.
Status of Labeling e.g. by using labels or by computer.

Each stage is identified by status Labeling.
Issue of Materials to manufacturing and package.

The Warehouse Pharmacist issues the material for manufacturing and packaging to Production
Officer in presence of Quality Assurance Officer.
The Control of Weighing.

For Dispensing of the Raw Material for manufacturing, each material is weighed by the Warehouse
Pharmacist in presence of Production Officers and the Quality Assurance Officer verifies the correct
weight as per requirement mentioned in the Manufacturing Order/ Material Requisition.
Checking Method.
Before Dispensing Calibration of the balance is checked by the Quality Assurance Officer in
presence of Warehouse Pharmacist and Production Officer.
How Identity of the Materials being used for manufacture confirmed?

WB/SMF/QF/001
While taking the sample according to Sampling Plan (MIL 105E) the Quality Assurance Officer takes
samples from each container/ pack for identification test, i.e. 100 % sampling is being done to
check the identity of the material to be used for manufacturing of the product.
C.5.2.1 Control of Bulk Manufacturing.

All the parameters required for filling and packing are checked during filling and packing.
Before filling the following parameters of the bulk material will be checked
 Identification Test
a) UV Spectroscopy
b) Chromatography (By HPLC)
 pH
 Clarity and color of solution
 Water Contents
 Bacterial Endotoxin
 Assay
a) By UV. Spectphotometer
b) By HPLC
Checks on Key Parameters during filling (Ready to Fill)
During filling all the following parameter are being checked
 Weight Variation
 Optic (Particle) Test
 Sealing Test
 Environmental Monitoring
Records of Key Parameters

All the parameters record in the relevant forms.
In-process Checks
During filling following in-process checks are performed.
 Weight Variation
 Optic (Particle) Test
 Sealing Test
 Environmental Monitoring (Monitoring of Temperature and Relative Humidity) of the Room
where filling process takes place.
Records of In-process Checks

Weight Variation check records in the Dose Monitoring Sheet
Optic (Particle) Test records in Optic Test Check Sheet
Sealing Test records in Sealing Test Check Sheet
C.5.2.2 Packing
Release of Bulk, Semi-finished products, and packing materials
1. Receive GRN/Intimation to QAD for Test/Analysis from Warehouse/Production Department.
2. Collect sample from Warehouse (for Raw and Packaging Material) /Production Department
(for bulk semi-finished and finished products).
3. QA Officer submits the samples to Quality Control for testing purpose.
4. Samples analyzed by the Quality Control according to the relevant Specification/ SOP.
5. Quality Control submits the results to Quality Assurance for further action
6. Quality Assurance analyzed the results.
7. If it meets the specifications it is released for next stage.
8. QAD gives the release on GRN/Intimation to Warehouse/Production Department.
In case of Raw Material QAD assign the retest date according to following program
iv. After one Year Incase of Active Raw Material having Mfg. & Exp. Dates
v. After two Year Incase of Inactive Raw Material having Mfg. & Exp. Dates
vi. After 6 months Incase of Inactive Raw Material with no Mfg./ Exp. Date
9. Reject the Raw/Packaging materials if it does not meet standard specifications please refer
to SOP of Non-Conformance.

WB/SMF/QF/001
10. After completion of Batch and audit of BPR by QAD, QAD sends “Released Sticker” for
“Released for Marketing” on the basis of Production Order.
11. After “Released for Marketing” QAD sends one copy of Production Order (MO & PT) to
accounts section while the other copy of PO is retained in BPR.
Procedure of Line Clearance
a. When batch is ready to be processed, Quality Assurance Inspector deputed in the specific
section inspects the cleanliness of area, machines, containers, scoops and tubs etc., for giving
line clearance before the start of new product.
b. QAI checks the product, B.No, B. Size, Mfg Date, Exp. Date on the identification slip. Check the
release from QAD for the stage going on.
Check the humidity, temperature if applicable. Assure that none of the previous material /
products are present. In case of packing, QAI checks the belt and surrounding of the belt if it is
completely cleared from the material of previous batch or other products, i.e. unit carton, labels,
inserts, major carton, filled bottles, filled vial, Ampoules tablets capsules etc. process records.
c. QAI enters the previous product and B.No. in Batch Processing Sheet and verifies that all
material of previous product has been removed.
d. QAI signs on relevant batch Processing Sheet as line clearance and pastes Line Clearance
Certificate on machines/equipment.
e. When the Batch is completed and shifted to next stage, relevant Section Staff cleans the
machines/equipment, and pastes Cleaning Status Label on machines/equipment for next
activity or process.
f. The Quality Assurance Inspector verifies the cleanliness.
In-process Checks
a. Before starting the packing process, the QAI/ QA Officer checks the release for packing in
BPR.
b. The Sorting of the product (Tablet/ Capsules, filled Bottles/ Ampoules/ Vials the QAI/ QA
Officer performs the in-process inspection to check that the sorting being is carried out in
accordance with Specification of Sorting of Tablets or Specification of Sorting of Capsules and
then QAI signs the relevant BPS of the product as an evidence of satisfactory sorting.
c. For blister labeling; the QAI/ QA Officer gives the Line clearance according to the procedure.
d. Before giving the line clearance, check the cleaning, of scoops and containers etc. check and
ensure the product name, Batch No., Batch Size, Mfg. & Exp. Dates, on identification slip of
the containers.
e. QAI/ QA Officer Checks and ensures that the release from Quality Assurance Department for
the stage going on.
f. QAI/ QA Officer assures that none of the pervious product are present. Check the humidity /
Temperature if applicable.
g. QAI/ QA Officer issues the line clearance certificate for machines/belt and verifies in the
B.P.S. In case of packing belt, check that belt and surrounding of belt are completely clear
from material of previous batch or products i.e. unit carton, labels, inserts, tags, master
carton, bottles, vials, ampoules, granules, tablets, capsule and records. Record the previous
product and batch number in BPS.
h. Before Packing, the blisters/ Labeled Vials or ampoules are sorted, the QAI/ QA Officer checks
that the sorting is carried out in accordance with Specification for sorting of blisters and signs
at relevant place in relevant BPS as an evidence of satisfactory sorting.
i. QAI/ QA Officer gives the Line Clearance and checks that the correct packing material is being
used, paste in BPS and signs the sample of packing material as an evidence of correct
material being used.
j. QAI/ QA Officer also gives Line Clearance before printing of Packaging Material (i.e. Printing of
Batch No., Mfg. Dates, Expiry Dates and Printing of Price)
k. During packing the QAI/ QA Officer checks the in-process packing and signs the In-process
packing check sheet as an evidence of satisfactory packing.
l. The QAI/ QA Officer has an authority to open any doubtful carton again even after packing.
C.5.3 Arrangement for handling Reject Material and products.

The company WELLBORNE (PVT.) LTD. has a comprehensive policy and procedures for the handling
of rejected materials and products. The material or products which do not conform to the quality
standard as mentioned in material specification or product specification are declared non

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conforming products. These materials or products are placed in segregated areas called “Rejected
Area”.
Then a comprehensive non-conformity report is generated. After thorough investigation in order to
eradicate the causes, the material or product is finally declared as rejected. In case of raw
material, it is returned back to supplier and in the case of packing material or product, it is
incinerated in our own incinerator. During all of these practices a complete documentation is
carried out and these documentations are kept secure as long as GMP guidelines indicate.
Quality Assurance department strictly monitors all of these activities.
C.5.3.1 Are rejected material clearly labeled? Are the stored securely in a dedicated
store?
Yes all the rejected material are Labeled by the relevant department with the “Red Rejected Label”
issued by the Quality Assurance Department. All the rejected material or product is securely stored
in the rejected area in Warehouse
C.5.4 Brief Description of general policy of the Process Validation:

Two approaches of process validation have been taking one is Concurrent Validation and the other
is Retrospective Validation
In Concurrent Validation all the critical process are monitored and one variable is assessed to
ascertain the quality and the validity of the process, for this purpose the final blending time is
validated.
Whereas in Retrospective Validation the historical data of all the testing parameter of the last
consecutive 20 batches of a product is taken and assessed by the application of statistical
techniques all the results are also shown by the means of graphs to show the trend.
C.6 Quality Control:

The Quality Control Department comprises of Chemical Lab, Microbiology Lab.
Chemical Lab is performing chemical analysis of Raw Material, In-process and finished products.
The Microbiology lab is performing microbiological in-vitro* testing and microbiological in-vivo**
testing.
*Testing of pharmaceutical products under controlled laboratory conditions.
For vendor sample the assigned analyst performs the test of samples and or relevant standard
according to United States Pharmacopoeia or other pharmacopoeia, British Pharmacopoeia if SOP is
not present.
After the completion of the tests, results are checked by Quality Control Manager for compliance
against product specification / material specification or in case of vendor sample any
pharmacopoeia. The assigned analyst enters the name of the test with date in the equipment log
book as an evidence of the test for traceability purposes.
If the result complies the assigned analyst enters the result in intimation to Quality Assurance
Department for test / technical information sheet / GRN and relevant analytical report register.
For active raw material testing assigned analyst also enters the results in raw material result sheet
and sends the copy to Quality Assurance Department, after got it signed by Q.C. Manager for in
active and re-test raw material analyst enters the results in raw material register.
For vendor sample, the assigned analyst enters the results in vendor sample test report and
relevant analytical report register.
For all injectable products, stability samples, method and process validation, the assigned analyst
enters the results in the respective register.
To protect the environment and community, effluent water is checked from different points of the
organization and drinking water is also checked, results are entered and send to Quality Assurance
Department.
If the results do not comply, the assigned analyst enters the results in relevant analytical report &
registers and submits to Q.A. Department after getting it signed by the Quality Control Manager.
The
Quality Assurance Department provides new sample with new technical information sheet and ask
for repeat test.
The Quality Control Department retains the sample of active raw materials for further reference;
the retained sample of raw material is entered in register and labeled for identification.

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The in-house reference standards of raw material are retested after every six months and the
results are entered in in-house reference standard register.
The Quality Control Department maintains the chemicals, media and glassware inventory, the
temperature sensitive reagents and chemicals are placed in refrigerator to avoid any hazard.
C.6.1.1 Packaging Component Testing:

Upon the arrival of the consignment, the Warehouse intimate the Quality Assurance Department
through GRN (Goods Receiving Note) , then Quality Assurance Officer responsible for the checking
of the Packaging Material Components takes the samples according to sampling Plan (MIL 105E)
and checks the samples against the copy of approved Art work and relevant Packing Material
Specification.
If the Packing Material Component complies with the relevant Specification then Quality Assurance
sends the copy of approved GRN along with Released Labels, otherwise follow the SOP of Non
Conformance (WELLBORNE (Pvt) LTD, for handling to non conforming Packaging Material
Component.
C.6.1.2 Batch documentation and release of Final product:

Production Department receives the Production Order along with Batch Process Sheet from Supply
Chain Department, the relevant section in-charge files the Batch Processing Sheet and other
documents in file which will be called as Batch Processing Record (BPR) and takes the material
from warehouse as per standard operation procedure of issuance or Raw/Packing Material from
store. During the whole manufacturing and packing process different documents are used and
attached in the relevant BPR after duly signed by the Section Incharge.
Following documents are attached in the BPR,
 Manufacturing Order
 Packaging Order
 Batch Processing Record Check List
 Batch Processing Sheet
 Dispensing Tags
 Line Clearance Certificate
 Technical Information Sheet (if required)
 Intimation to QAD for test/ Analysis
 Analytical Report
 In process Check Record Sheets
 Humidity, Temperature and Positive Pressure Record Sheet( in case of Injectable Filling)
 Requisition for Printing of Packaging Material
 Blister Machine In process Check Sheet
 In Process Packing Check Sheet
 Return Reject Note
 Copy of Nonconformance Report.
 Finished Goods transfer to Warehouse (Transfer Ticket)
After completion of the final packing, the Production Officer compiles the Batch Processing Record
and reconciles the batch yield stage wise. After final reconciliation the Production Officer hand over
the complete Batch Processing Record to QA Officer for audit on the floor, the QA Officer thoroughly
audit the file and submits the file to the Deputy Manager Quality Assurance for verification and final
audit, the Deputy Manager QA verifies the Batch Processing Record after ensuring that appropriate
operations, processes and in-process inspections have successfully been performed and all
discrepancies (if any) have been removed.
Finally the Deputy Manager Quality Assurance signs the Batch Processing Sheet as an evidence of
final Batch Processing Record Audit and sends to Quality Assurance Manager for approval.
a. The Quality Assurance Manager releases the product for marketing on the basis of final BPR
audit and sends the computer generated Released Labels to Warehouse. Upon receiving of the
Released Labels the Warehouse Shifted the Finished Goods from Finished Quarantine area to
Finished Goods Released area.
C.6.1.3 Involvement of QAD in the Documentation of Specification & test methods.

The complete system of the Documentation and data control is discussed in the section C.4

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C.8.0 Distribution:
C.8.1 Description on Storage and Distribution Practices
 Receive & process demand, Summary, Invoices & DC’s for dispatches.
 Ensure that the routine Invoices are being received before 2:00 pm & hand over vaccines to
courier before 6:00 pm for next day delivery.
 Review the documents & report in case of any variation.
Note:
o Invoices against DCs – only Warehouse copy should be sent.
o Invoices with issued stocks should not be altered / cancelled in any case. Make
Goods Returned Note & issue new Invoice.
o In case of Institutional supply, special instructions regarding stamping, shelf life &
DTL samples should be clearly mentioned on the Demand Note.
 Conduct physical check of stocks & manage dispatches accordingly.

 Forward a batch variation & correction report on daily basis to all concerned.
 Draw the stock (to be dispatched) & strictly check & maintain the batches & quantities as
mentioned in the summary / invoices.
 Segregate the stock as per invoice.
 Ensure stock turnover according to FIFO system.
 Stamping of stock as per consignee instructions.
 Pack the stock & ensure that the transportation & handling requirements are being
employed properly.
 Make sure that the cold chain is being perfectly maintained in case of vaccine supply,
particularly in case of supply to remote areas.
 Verify the marking executed by courier & confirm that the booking by courier is being done
accurately.
 Check the booking receipts issued by courier & verify number of cartons & consignee’s
address.
 Prepare & forward a daily dispatch report.
 Keep record of all documents.
C.8.1.1 The Warehouse is safe and secure.

C.8.1.2 The Warehouse is environmentally controlled, to control the environmental conditions;
the Environmental Monitoring (Temperature and Relative Humidity) is being performed
three times in a day.
C.8.1.3 There are three Cold Rooms (Refrigerated Rooms) the temperature of the Cold Rooms is
maintained at 2.0 to 8.0 °C
C.8.1.4 There are Racks are available for stacking the material
C.8.1.5 The status of the products is controlled by labeling of the product stage wise.
C.8.1.6 There is an isolated area for the storing the rejected material safely.
C.8.1.7
o Receive & process demand, Summary, Invoices & DCs for dispatches.
o Ensure that the routine Invoices are being received before 2:00 pm & hand over
vaccines to courier before 6:00 pm for next day delivery.
o Review the documents & report in case of any variation.
C.8.1.8 The dispatch order ensures the FIFO System and each product is identified by the Lot/
Batch No’s.
C.8.2 Records of Distribution:

 Document each action & keep record of every document – Invoices, DCs, FOCs, Courier
receipts, Dispatch reports & Sales reports, Receipt note & Returned note.
 Make sure that the daily transactions are being kept accurately & entered in to a register /
ledger.
 Ensure that the batch wise record is being maintained specifically.
 Make sure the updated upholding of ledger & bin cards to follow any feedback.

WB/SMF/QF/001
 Conduct the audit on weekly basis to explore any ambiguity & rectify it on immediate basis.
 Ensure regular stock taking & audit (monthly, quarterly & yearly basis) & maintain for
record.
 Report any stock shortage / surplus to concerned authority.
C.8.3 Handling of Complaints:

Written and verbal Customer Complaints are received to the General Manager Plant Operations
either directly by the customer or through the marketing department. The verbal customer
complaints are noted down on Customer Complaint form by the General Manager Plant Operations
for investigation. The Customer Complaint Form is then sent to Quality Assurance Manager for
further investigation.
The Quality Assurance Manager enters the Customer Complaints Number and brief description in
Customer Complaints Register.
A panel comprising of the following officers is responsible for investigating the causes of Customer
Complaint:
a. Quality Assurance Manager
b. Production Manager
c. Quality Control Manager
d. Research and Development Manager
The Quality Assurance Manager may also coordinate with any other concerned personnel.
After receiving the customer complaint, the QAM initiates the investigation by discussing all
possible aspects of the said complaints, the aspects may include:
a. Testing/inspection of complaint sample in comparison with the retained sample if required.
b. Reviewing the Batch History Record including any deviation recorded if necessary.
c. Reviewing the production operation.
d. Reviewing any relevant regulatory requirements mandatory for the process.
e. Storage conditions:
The panel may also review the environmental conditions of the complaints from where it was
originated.
The result of investigation proposed by the panel may be as follow
i. Product recall (refer to SOP for Product Recall)
ii. Improvement in the system (Continual Improvement for CPAR).
iii. Improvement on part of Marketing Department.
iv. No Change (Complaint is unjustified).
If any nonconformity is identified in process/product during investigation, the Quality Assurance

Manager initiates Corrective and Preventive Action Request to the responsible officers.
After completion of investigation, the Customer Complaint form with all other necessary documents
attached are then submitted to GM Plant Operations for review. The GM Plant Operations may call
relevant personnel for the discussion on the Customer Complaint if desired necessary. Then the
reviewed customer complaint is submitted to the Managing Director for approval. After approval of
the investigation carried out on Customer Complaints, the Quality Assurance Manager enters the
closing date if any in Customer Complaints Register and these are archived in QAD.
The General Manager Plant Operations may intimate the causes and/or any necessary improvement
action on Customer Complaints to the Marketing Department if advised by the Managing Director.
C.8.4 Product Recall:

Product recall is a procedure of withdrawing or removing all units of a particular batch of a
pharmaceutical product from a pharmaceutical distribution chain because of defects in the product
or complaint of serious adverse reaction of the product.
If a recall is identified and becomes necessary, it must be effected immediately and efficiently.
i. Reasons for a Recall

Following are the basic reasons for a recall of a pharmaceutical product.
S.No. Reason Description

1. Potency Failure to maintain potency at certain times during
shelf life of the product.
2. Labeling/Packaging mix-up For examples, incorrect strength on label, wrong
WB/SMF/QF/001
product in bottle
3. Miscellaneous Product problems
Discoloration, leaked bottles, particulate matter, etc.
4. Dissolution Failure to dissolve at certain time during shelf life of
the product
5. Contamination Physical, Chemical and Microbiological contamination
ii. Condition of Recall:
 Condition of Recall:
The company will initiate the recall when critical quality defects are identified and confirmed. The
defects are usually reported by:
a. Outside agencies:
Outside agencies are wholesalers, retailers, hospitals, doctors and consumers.
1. Inside agencies:
Inside agencies are marketing department, Quality Assurance Department (during stability studies)
and Finished Goods Warehouse.
b. Classification of Defects in Quality:

The defect in quality should prove to be true beyond all possible doubts. The defects in quality can
be classified as follows,
Class – 1: Is a situation in which there is a strong reasonable probability that the use of or
exposure to, a defective product will cause serious, adverse health consequences or
death.
Class – 2: Is a situation in which the use of or exposure to, a defective product may cause
temporary or medically reversible adverse consequences, or where the probability of
serious adverse health consequences is remote.
Class – 3: Is the situation when the use of or exposure to, a defective product is not likely to
cause adverse health consequences.
Depth of Recall:
Depending on the product’s degree of hazard and extent of distribution, the recall strategy will
specify the level in the distribution chain, to which the recall is to be extended as follows,
Recall Type A: Upto consumer level
Recall Type B: Upto all distribution level
Recall Type C: Upto certain distributions level
Top priority will be given to recall work by all concerned, even if recall has to be processed after
working hours or on holidays, and the information about recall should immediately be sent to all.
b. Responsibility/Authority
After the quality defect has been identified and proved to be true beyond all possible doubts, the
Quality Assurance Manager brings the suggestion and the necessity of the recall to the notice of the
General Manager Plant Operations, the GM Operations Manager after evaluation immediately
reports any potential or actual recall to the Managing Director. The Managing Director has the final
authority to grant a recall of pharmaceutical product.
All the facts relating to the product quality, medical aspects, analytical reports, market impact,
possible legal action, and company’s reputation will be considered while taking the decision for a
recall of a pharmaceutical product.
c. Recall Procedure
i. Elements of a Recall Procedure:
j. There may be many elements of a recall procedure, but there may be three major elements of
recall.
 Communication:
After becoming aware of a product recall, the Quality Assurance Manager will need to communicate
the recall to other related authorities.
The responsible person should need to know about,
a. Who to contact,
b. What to communicate,
c. When to send out communication and

WB/SMF/QF/001
d. How to communicate.
 Product Handling:
Establishing a written procedure for how the product is to be handled should address such items as
identifying the recalled product, locating the product in pharmacy, quarantining the product and
returning the product & reconciliation.
 Record keeping:
Document all the actions in a recall range from the simple determination of fact e.g. which product
was affected, whether patient notified? Documenting the actions during recall can be greatly
facilitated by forms and checklists.
ii. Preparatory Measures:

The Quality Assurance Manager will be responsible for a recall whereas the production Manager,
Assistant Manger Warehouse and Marketing Manager will acts as coordinator. The General Manager
Plant Operations, Coordinator to M.D and in turn Managing Director will be kept informed on the
follow up of the recall.
Name and addresses of the above mentioned responsible persons In absence of above mentioned
responsible persons their deputies will assist in the recall. Following functions are to be performed
by the specified responsible persons
 Collect and communicate all the information regarding a recall to inside where appropriate and
with the permission of Managing Director to outside agencies.
 Quarantine all stocks of a defective product and block any further distribution.
 Ensure the availability of the names, addresses and telephone numbers of all channels of
communication and distributors.
1. Product Distribution Record System:
Finished Goods warehouse/ Computer Section keep the product distribution record to various
distributors across the country. These records specify the quantity and batch No. of a particular
product dispatched to a distributor. The distributors in turn keep a record of onward sale to
pharmacies, chemists, institutions, hospitals etc. This record is in the form of invoice. Product
distribution records are the basis of an effective recall, this record should have complete and
quantitative distribution of any batch.
In order to ascertain the effectiveness of a recall procedure it should periodically be validated.
iii. Recall Advice (Announcing the Recall):
The responsible person for recall will keep ready the text for announcing the recall, the text
(Annexure-II attached) may include,
 Product Name,
 Batch Number,
 Reason for recall,
 Instruction to quarantine the remaining product,
 Not to sale any more,
 Not to use the product and
 The stock should be returned to identified place immediately.
1. Action Plan:
 Quality Assurance Manager will first evaluate if a recall is necessary and immediately suggest a
recall to General Manager Plant Operations.
 The General Manager Plant Operations will get the authorization of recall from Managing
Director / Chairman.
 Upon receiving the authorization, the management will decide and order for recall.
 Manager Quality Assurance designates a responsible person for the execution and coordination
of recall activity.
 According to the type of recall, Persons responsible for recall will immediately contact with,
a. Marketing staff
b. Distributor/Institutions
c. Information media
d. Government officials.

WB/SMF/QF/001
 The distribution records should be readily available to the Quality Assurance Manager and
responsible persons, and it should contain sufficient information on wholesaler and directly
supplied customers (including for exported products, those have received samples for clinical
tests and medical samples) to permit an effective recall.
 Persons responsible for recall will immediately hold all of the product in the finished Goods
warehouse. Immediately hold all the stocks of the product in all external distributors.
a. Advice the sales staff to vigilantly look and seize any leftover stock in the market retailer
shop.
b. Request for the immediate return of the product to finished goods warehouse.
 In case of recall of type A, information to government officials and then to public in general
through TV, Radio and Newspapers, should only be given after getting authorization from
Managing Director.
 Following arrangements should be made for recall,
a. Designate a segregated place in Finished Goods Warehouse with proper identification
b. Assistant Manager Warehouse keeps records of all the returned goods of the recalled product.
c. AM (Warehouse) should keep the daily information of the total receipt of recalled product and
inform to all concerned.
d. Feed back to the distribution channels about the quantity received and the quantity still
pending with them.
 All competent authorities to which a given product may have been distributed should be
promptly informed of any intention to recall the product.
 The progress of recall should be recorded and a final report issued, including reconciliation
between the delivered and recovered quantities of the product.
 The effectiveness of the arrangements for recalls should be evaluated from time to time.
vi. Final Report:

The Quality Assurance Manager will prepare a final report for a recall event of a product including
reconciliation between the delivered and recovered quantities of the product and submit the report
to the Plant Manager.
The General Manager Plant Operations reviews the report and gets approved the report by the
Managing Director / Chairman.
vii. Reprocess/Distraction
For reprocess/destruction of a recalled product refer the SOP of Quality Assurance Department
vii. Documentation:
All the relevant documents, files, letters, action plan, reprocess/destruction record etc of a recalled
product should be archived and readily available in Quality Assurance Department.
C.9.0 Self Inspection:
C.9.1 Self Inspection Program.

In WELLBORNE (PVT.) LTD. The Self-Inspection System covers the maximum aspects/requirements
of cGMP. The procedure for the implementation of the Self-Inspection is as under.
i. The departmental/ sectional heads designate any officer of the relevant area for Self-
Inspection and mention the name of the Officer in the column of responsibility in Self-
Inspection Checklist.
ii. The designated Officer fills the Self-Inspection Checklist by mentioning department, section
and area highlighting the month in which the inspection will be executed.
iii. The designated officer performs Self-Inspection according to Self-Inspection Checklist as per
predefined frequencies.
iv. The Officer either tick () on the columns of the checklist incase the requirement are fulfilled
or cross (X) incase the requirement are not fulfilled.
v. +66The Internal Audit Team also acts as Self-Inspection Team to check the implementation of
the system and for the follow-up actions.
vi. At the end of the month, the responsible officer submits the Self-Inspection Checklist to the
Sectional/Departmental head.

WB/SMF/QF/001
vii. Both the departmental/ sectional head evaluate the checklists for the implementation/
compliance of the cGMP requirements and take action if required.
viii. The departmental/ sectional head signs the Checklist and archives in their own department.
C.9.1 How the Self Inspection System verifies that those activities that have bearing on
quality comply with the planned arrangement.
The Self-Inspection System is to evaluate the compliance with cGMP on periodic basis to detect any
shortcomings in the implementation of Current Good Manufacturing Practices that could affect
the quality of the product.
C.9.2 Are the Quality System effective.

The Quality System in WELLBORNE (PVT.) LTD. is effectively implemented.
C.9.3 Are there documented procedure for the Self Inspection System and for the
follow-up actions.
Yes there is a documented procedure (available for the effective implementation of the self
Inspection System and for the follow-up actions.
C.9.4 Are the results of Self Inspection System documented, brought to the attention of
the personnel having the responsibility for the area and activity inspected.
Yes the results of Self Inspection System documented and brought to the attention of the
personnel having the responsibility for the area and activity inspected.
C.9.5 Does the System ensures that those responsible for the area or activity take timely
corrective action on the deficiency found.
 In case the requirement does not comply; the responsible officer informs the relevant
departmental/section head to take measures for rectification.
 If the identified problem pertaining to any other department/section then the departmental/
sectional head informs Quality Assurance Manager for rectification.
 The Quality Assurance Manager may either raise Corrective & Preventive Action Request
depending on the magnitude/ severity of the deviation to the responsible section head.

WB/SMF/QF/001
9.0 COPY OF DRUG MANUFACTUIRNG LICENSE

Attached Annexure 05

WB/SMF/QF/001
10.0 COPY OF GOOD MANUFACTURING PRACTICES (GMP) CERTIFICATE


WB/SMF/QF/001
1.0 COPY OF ISO CERTIFICATE


WB/SMF/QF/001

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Document No.

Effective Date 01-01-2019

Issued By: Reviewed By: Approved By: Authorized By:

SITE MASTER FILE

M/s. Wellborne Pharmachem & Biologicals

Phone No. 0995617333

1.3 Other Manufacturing Activities At The Site

8.0 SELF INSPECTION

Terms & Definitions:

Copy # Controlled Copy: Not to be duplicated Page 4 of 60

C.1 General Information:

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1.2. PHARMACEUTICAL MANUFACTURING ACTIVITIES AS LICENSED BY THE GOVERNMENT

1.3 OTHER MANUFACTURING ACTIVITIES AT THE SITE

1.4 NAME AND ADDRESS OF THE SITE

M/s. Wellborne Pharmachem & Biologicals.

E-mail: info@wellbornepharma.com / borne.well@yahoo.com

Details of Contact Persons:

Sr. No. Name of the Person Designation Phone No.

1 Mr. athar Rana CEO 03215050600

1.5 TYPES OF PRODUCTS MANUFACTURED AT THE SITE

List of Products Licensed attached as under (Pharmaceuticals Health)

1.6 DESCRIPTION OF THE SITE

1.6.2. SIZE OF SITE & AREA

Total Area: 2 Acre

Total covered Area: 22000 Sq. Ft

Copy # Controlled Copy: Not to be duplicated Page 8 of 60

Production covered Area: 19380 Sq. Ft

1.7 LIST OF TECHNICAL STAFF

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S.NO. NAME DESIGNATION QUALIFICATION EXPERIENCE

1 Mr. Ifthikhar Ahmad khan Production Manager B. PHARMA 20 Years

2 Mr. Mohammad Zubair Production Manager B. PHARMA. MPhil 10Years

4 Miss Masooma Microbiologist MPhil Microbiology 02 Years

5 Mr. adil shah QA Inspector B.Sc. 02 Years

6 M.Zain Qc Analyst MSC Chemistry 01 Years

7 M.Saquib Production Pharmacist Pharm. D 03 Years

1.8 EXTERNAL TECHNICAL ASSISTANCE

1.9 QUALITY MANAGEMENT SYSTEM

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WELLBORNE’s mission is to bring value to the patients and customers

WELLBORNE’s is striving to be leader among all national companies in all of its

As an ethically, socially and ecologically responsible organization, WELLBORNE

WELLBORNE’s considers these principals to be essential

WELLBORNE’s is striving to continuously improves all of its processes through

WELLBORNE’s will insist on full compliance.

Dr. Athar Rana

 Quality Management System, covering the requirements of ISO 9001:2015.

2. General Requirement of Quality Management system:

To implement these Quality Systems, the Organization has managed to;

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3.1 Control of Documents

3.2 Control of Records

7. Objectives and Targets

 The processes of the Quality System, considering permissible exclusions.

9. Legal and Regulatory Requirements

1.9.1. QUALITY POLICY

WELLBORNE’s mission is to bring value to the patients and customers

WELLBORNE’s is striving to be leader among all national companies in all of its

As an ethically, socially and ecologically responsible organization, WELLBORNE

WELLBORNE’s considers these principals to be essential

WELLBORNE’s is striving to continuously improves all of its processes through

WELLBORNE’s will insist on full compliance.

Dr. Athar Rana