Quality Manual (ISO-9001)

ISO 9001 QMS CCL Pharmaceuticals
Document No.: QM-001-D Replaces: QM- 001-C

Issue Date: April 27, 2015 Effective Date: May 11, 2015 Review Date : May, 2018
Prepared By: Reviewed By: Approved By:
Quality Assurance ISO Management Director Plant Chief Operating Officer
Manager Representative Operations
Quality Manual
The quality manual establishes and states the policies governing

The Company’s Quality Management System. These policies define
management’s arrangements for managing operations and activities in
accordance with ISO 9001:2008. These top-level policies represent the
plans or protocols for achieving quality assurance and customer
satisfaction.
Quality Manual If the Logo on this page appears Black it is an uncontrolled copy Page 1 of 32
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CCL Pharmaceuticals (Pvt.) Ltd.

CCL Pharmaceuticals (Pvt.) Ltd.
QUALITY
MANUAL
QUALITY
MANUAL
QUALITY MANUAL
Table of Contents
1.0 PURPOSE………………………………………………………………………….1 6
2.0 SCOPE……………………………………………………………………………..1 6
3.0 RELATION TO ISO 9001:2008…………………………………………………...16
4.0 OUR COMPANY QUALITY MANAGEMENT SYSTEM………………………16
4.1 General Requirements……………………………………………………………...16
4.2 Documentation Requirements……………………………………………………...38
4.2.1 General……………………………………………………………………………..3 8
4.2.2 Quality Manual……………………………………………………………………..38
4.2.3 Control of Documents……………………………………………………………....38
4.2.4 Control of Record…...……………………………………………………………...49
4.2.5 Referenced Procedures: ……………………………………………………………..4 9
5.0 MANAGEMENT RESPONSIBILITY…………………………………………….49
5.1 Management Commitment………………………………………………………....49
5.2 Customer Focus…………………………………………………………………….49
5.3 Quality Policy………………………………………………………………………410
5.4 Planning…………………………………………………………………………….510
5.4.1 Quality Objectives………………………………………………………………….510
5.4.2 Quality Management System Planning…………………………………………….510
5.5 Responsibility, Authority, and Communication……………………………………511
5.5.1 Responsibility and Authority……………………………………………………….511
5.5.2 ISO Management Representative………………………………………………………..5 11
5.5.3 Internal Communication…………………………………………………………….611
5.5.4 Referenced Procedures: ……………………………………………………………611
5.6 Management Review………………………………………………………………..611
5.6.1 General……………………………………………………………………………...611
5.6.2 Review Input………………………………………………………………………..611
5.6.3 Review Output………………………………………………………………………612
5.6.4 Referenced Procedures……………………………………………………………...712
6.0 RESOURCE MANAGEMENT……………………………………………………..712
6.1 Provision of Resources……………………………………………………….......…712
6.2 Human Resources…………………………………………………………………...712
6.2.1 General………………………………………………………………………………712
6.2.2 Training Procedure…………………..……………………………………………... 12
6.2.3 Referenced Procedures: ……………………………………………………………..7 13
6.3 Infrastructure………….……………………………………………………………..813
6.4 Work Environment…………………………………………………………………..8 13
7.0 PRODUCT REALIZATION…………………………………………………………8 13

7.1 Planning of Product Realization ……………………………………………………..8 13
7.2 Customer related Processes…………………………………………………………..8 13
7.2.1 Determination of Requirements Related to the Product……………………………...8 13
7.2.2 Review of Requirements Related to the Product……………………………………..9 14
7.2.3 Customer Communication……………………………………………………………9 14
7.2.4 Referenced Procedures………………………………………………………………..9 14
7.3 Design and Development……………………………………………………………..10 15
7.3.1 Design and Development Planning. ……………………………………………….....10 15
7.3.2 Design and Development Inputs. …………………………………………………….10 15
7.3.3 Design and Development Output. …………………………………………………....10 15
7.3.4 Design and Development Review. …………………………………………………...11 15
7.3.5 Design and Development Verification. ……………………………………………....11 16
7.3.6 Design Validation……………………. ……………………………………………....11 16
7.3.7 Design Changes….……………………. ……………………………………………..11 16
7.3.8 Referenced Procedures: …………………. …………………………………………....12 16
7.4 Purchasing………………………………. ………………………………………..….12 16
7.4.1 Purchasing process. ……………………. …………………………………………....12 16
7.4.2 Purchasing information ……………………. ………………………………………..12 17
7.4.3 Verification of purchased product…………. ………………………………………...12 17
7.4.4 Referenced Procedures: …………. …………. ……………………………………....12 17
7.5 Production and Service Provision. . …………. ……………………………………....13 17
7.5.1 Control of Production and Service Provision…………………………………………13 17
7.5.2 Validation of Processes for Production and Service Provision……………………….13
18
7.5.3 Identification and Traceability………………………………………………………...13 18
7.5.4 Customer Property…………………………………………………………………….14 18
7.5.5 Preservation of Product………………………………………………………………..14 18
7.5.6 Referenced Procedures: ………………………………………………………………14 18
7.6 Control of Monitoring and Measuring Devices……………………………………….15 18
7.6.1 Calibration Activities………………………………………………………………….15 19
7.6.2 Referenced Procedures: ………………………………………………………………15 19
8.0 MEASUREMENT, ANALYSIS AND IMPROVEMENT……………………………16 19
8.1 General…………………………………………………………………………………16 19
8.2 Monitoring and Measurement………………………………………………………….16 20
8.2.1 Customer Satisfaction………………………………………………………………….16 20
8.2.2 Internal Audit…………………………………………………………………………..16 20
8.2.3 Monitoring and Measurement of Processes……………………………………………17 20
8.2.4 Monitoring and Measurement of Product………………………………………………17 21
8.2.5 Referenced Procedures: ………………………………………………………………..17 21
8.3 Control of Nonconforming Product…………………………………………………….17 21
8.3.1 Nonconforming Product Actions……………………………………………………….18 21
8.3.2 Referenced Procedures …………………………………………………………………18 21
8.4 Analysis of Data………………………………………………………………………...18 22
8.4.1 Quality Management System Evaluation………………………………………………18

22
8.4.2 Referenced Procedures…………………………………………………………………18 22
8.5 Improvement……………………………………………………………………………19 22
8.5.1 Continual Improvement………………………………………………………………...19 22
8.5.2 Corrective Action……………………………………………………………………….19 22
8.5.3 Preventive Action……………………………………………………………………….19 23
8.5.4 Referenced Procedures: ………………………………………………………………...19 23
Revision History …………………………………………………………………. 23
Terms and Definitions……………………………………………………………..…… 21—30
24—32
List of Referenced Procedures

CQP-001- Management Responsibility
CQP-002- Process Control
CQP-003- Contract Review
CQP-004- Design & Development
CQP-005- Document Control
PRO-101- Procurement
CQP-007- Product Identification and Traceability
CQP-008- Control of Inspection, Measuring & Test Equipment
CQP-009- Inspection and Test Status
CQP-010- Control of Non-Conforming Product
CQP-011- Corrective and Preventive Action
CQP-012- Handling, Storage, Packaging, Preservation & Delivery
CQP-013- Control of Company Quality Records
CQP-014- Internal Quality Audit
DEV101- Training Procedure
CQP-016- Statistical Techniques
CQP-017- Infrastructure and Work Environment
CQP-018- Inspection and Testing
CQP-019- Customer Survey and Feedback
CQP-020- Legal and Regulatory Requirements
CQP-021- Internal Communication
CQP-022- Customer Complaint
HR-102- Position Description
CSD-104- Purchase Policy For Customer Services Request
1.0 PURPOSE: GO BACK

The purpose of this quality manual is to establish and state the general policies governing company
Quality Management System. These policies define management’s intended arrangements for
managing our operations and activities in accordance with the framework established by ISO
9001:2008. These are the top-level policies representing the company’s plan or protocol for
achieving quality assurance and customer satisfaction.
All departmental or functional policies and procedures written must conform and parallel these
policies. All changes to policies and procedures are required to be reviewed to ensure that there are
no conflicts with these policies stated in this Quality Manual (QM).
2.0 SCOPE
The policies stated in this manual apply to all operations and activities at Our Company. The scope
of our quality system may be stated as follows:
The design, development, manufacture and distribution of pharmaceutical products..
It is the responsibility of all departmental Head to help define, implement and maintain the
procedures required by this manual and to ensure all processes conform to these requirements. It is
the responsibility of all employees to follow procedures that implement these policies and to help
strive for continuous improvement in all activities and processes of CCL Pharmaceuticals.
EXCLUSIONS:
Validation of Special Processes
There are no special processes involved in the manufacturing of drugs in CCL Pharmaceuticals
where the process output cannot be verified after subsequent inspection and testing. Hence,
validation of special processes is not applicable.
3.0 RELATION TO ISO 9001:2008

For ease of reference, the sections of this manual are numbered to coincide with the equivalent
section numbers of the ISO 9001:2008 standard.
4.0 OUR COMPANY QUALITY MANAGEMENT SYSTEM

4.1 GENERAL REQUIREMENTS
Through this manual and associated procedures and documents, Our Company has established,
documented, and implemented a Quality Management System conforming to the requirements of
ISO 9001:2008. The system is designed to result in continually improving the effectiveness of Our
Company in the operation of the quality management system and in our ability to satisfy our
customers’ requirements.
Maintenance of this system is the responsibility of the ISO Management Representative in
conjunction with all Departmental Head.
This Quality Manual along with the associated procedures identifies the processes needed for the
Quality Management System at CCL (see Table 1. General Process Flowchart)
Table 1 General Process Flowchart

The ISO Management Representative maintains a document that identifies the sequence of these processes
and, in conjunction with the appropriate departmental Head, defines the interactions of the processes within
the procedures defining these processes. Processes for management activities, provision of resources,
product realization, and measurement are included. Procedures shall include the methods needed to ensure
the operation and controls of processes are effective. These processes will be managed in accordance with
the requirements of ISO 9001:2008.
Top Management will ensure the availability of resources to support the operation and monitoring of
processes through regular interaction with departmental Head and through review activities at Plant
Operational Committee (POC). Departmental Head and the ISO Management Representative will monitor,
measure and analyze processes and implement any actions necessary to achieve intended results and
continual improvement of the processes. These results will also be monitored at Plant Operational
Committee (POC).
Pharmacological Classification of Raw Materials
Cough Suppressants / Expectorants Anti Viral Anti Obesity
Antibiotics Anti Epileptic Anti Anxiety / Depressant
Anti Hypertensive Anti Histamin Anti Malarial
Anti Diabetic Anti Asthmatic Lipid Regulating Agents
Anti Rheumatics / Analgesic Anti Osteoprosis Iron Preparations / Haematinics
Anti Emetic Anti Allergic Vitamin & Minerals
Anti Ulcerative Anti Platelet Benign Prostatic Hypertrophy
4.2 DOCUMENTATION REQUIREMENTS GO BACK

4.2.1 General
This Quality Manual and the associated procedures are intended to satisfy the ISO 9001:2008
documentation requirements for a quality manual, procedures and statements of the Quality policy
and quality objectives, records required by the ISO 9001 standard are identified in the appropriate
procedures or the Quality Records procedure.
Departmental Head and supervisors are responsible for identifying any additional documents needed
to ensure the effective planning, operation and control of processes.
Procedures may vary in detail based on the size of the department or organization involved and the
type of activity performed. Procedure developers shall consider this as well as the complexity of the
processes and interactions, and the competence of the personnel involved. Where competence is used
to minimize the content in procedures, record, competence, awareness and training must support the
decision.
Documents may be any medium including: software programs, electronic text files, or hardcopy
documents for example.
The Quality system document structure is given below:
4.2.2 Quality Manual

The Quality manual includes the scope of the company quality system.
Each section of the manual reference appropriate implementing procedures, Interactions between
processes and defined in the manual or in the referenced procedure.
4.2.3 Control of Documents
All Documents required by the quality management system shall be controlled as defined below:
 Quality Manual (ISO Management Representative/Document Control)
 Quality System Procedures (ISO Management Representative/Document Control)
 SOPs (Departmental Head)
 Quality Plans (Departmental Head)
 Material and Product Specifications (Departmental Head)
 Position Descriptions (Human Resource)
 Records (Departmental Head)
 Quality System Documents (softcopies) (Document Control)
The procedure for control of documents ensures that:

a) Documents are approved for adequacy prior to release;
b) Documents are reviewed, updated as necessary and re-approved;
c) Documents are identified with current revision status;
d) The relevant versions of documents are available at all locations where activities essential to the
effective functioning of the quality operating system and process are performed;
e) Documents remain legible, readily identifiable and retrievable;
f) Applicable documents (regulations, notifications, etc.) of external origin are identified and their
distribution controlled.
g) 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.
Quality System Manual has been prepared by the Quality Assurance Manager, reviewed by ISO
Management Representative and approved by Chief Operating Officer. Controlled copies of Quality
System Manual are distributed to all the concerned persons in the controlled distribution list.
4.2.4 Control of Records: GO BACK
Procedures define appropriate records to be maintained in order to provide evidence of conformity to
requirements and of the effective operation of the quality management system. Records shall remain
legible, readily identifiable and retrievable. The Quality Records Procedure defines the control
needed for the identification, storage, protection, retrieval, retention time and disposition of records.
4.2.5 Referenced Procedures:
CQP-005- DOCUMENT CONTROL
CQP-013- CONTROL OF COMPANY QUALITY RECORDS
5.0 MANAGEMENT RESPONSIBILITY

5.1 MANAGEMENT COMMITMENT
The top management at CCL Pharmaceuticals shows its commitment to the quality management
system through the development and implementation of this company quality manual. Additionally,
management commitment is demonstrated thought the company quality policy, the specific
objectives that are set and reviewed during Plant Operational Committee (POC) and by providing the
resources required to meet our objectives for continually improving the effectiveness of our
operations and quality system.
The management team consisting of the Managing Director, Divisional and all Departmental Head is
chartered with ensuring our products and services meet customer as well as statutory and regulatory
requirements.
The company’s management demonstrates its commitment to the development and improvement of
the quality management system by:
a) Communicating to the organization the importance of meeting customer as well as regulatory and
legal requirements;
b) Establishing the company’s quality policy and quality objectives;
c) Performing management reviews
d) Ensuring the availability of necessary resources.
5.2 CUSTOMER FOCUS
The management ensures focus on improving customer satisfaction. It is maintained by setting and
reviewing objectives related to customer satisfaction at Plant Operational Committee (POC).
5.3 QUALITY POLICY

Our Company has established a Quality Policy that we feel is appropriate to our organization and
meets the requirements set forth in ISO 9001:2008. This policy is communicated throughout the
company. Departmental Head and supervisors are responsible for ensuring all employees understand
the policy. To ensure our policy remains appropriate, it is reviewed at least after two years at one of
our Plant Operational Committee (POC).
The Quality Policy:
1. The company shall provide effective, innovative and high quality products in Pakistan and
International markets.
2. The company shall design, develop, manufacture, and market high quality products.
3. The company shall achieve, maintain and develop market leadership in Pakistan and
International markets.
4. That every product and service shall be of premier quality.
5. All recruitments will be made strictly on merit and special emphasis will be given on training and
development of Human Resource
6. The company shall enhance the participation and job commitment of the employees through
motivation.
7. The company shall show honesty with employees, customers and business community.
8. We shall accept responsibility for our actions and contribute towards creating value for
company’s success as a whole and for all stakeholders
5.4 PLANNING GO BACK
5.4.1 Quality Objectives
The Company has established quality objectives at appropriate functions and levels within the
organization. These objectives are defined in measurable terms. The quality objectives are consistent
with the quality policy and the commitment to continual improvement and meeting requirements for
products.
5.4.2 Quality Management System Planning
The company establishes strategic objective for improvement of our products, processes and
customer satisfaction.
These objectives are supported by specific measures that track performance against those objectives.
Departmental Head in turn set departmental objectives with specific performance measures and
targets that support company objectives.
The company has established plans identifying the resources needed to achieve the quality
objectives.
Quality planning covers the following issues:
a) The processes of the quality management system, considering permissible exclusions;
b) The resources needed;
c) Continual improvement of the quality management system.
Planning ensures that change is conducted in a controlled manner and that the integrity of the quality
management system is maintained during such change(s).
Supporting Documentation: Corporate and Divisional Objectives
 Corporate Objectives
 Divisional Objectives Technical
5.5 RESPONSIBILITY, AUTHORITY, AND COMMUNICATION

5.5.1 Responsibility and Authority
Responsibilities and authorities at CCL are defined in each position description as well as the
management responsibility procedure. Position descriptions are available in Human Resources and
the copies are distributed to all employees of the company which are used during annual
performance review.
The organizational chart describes the hierarchical structure of CCL Pharmaceuticals. The position
descriptions of individuals describe the responsibilities and authorities of the company personnel.
The Quality System Procedures also describe the responsibilities of personnel in relation to various
quality system requirements.
Corporate Organogram, Technical Division, Production, Engineering, Quality Assurance &
Regulatory, Supply Chain:
5.5.2 ISO Management Representative
The Managing Director has appointed the Manager Quality Assurance as the ISO Management
Representative. Irrespective of other responsibilities, the ISO Management Representative has the
responsibility and authority to:
a) Ensuring that processes of the Quality Management System are established and maintained in
accordance with the requirements of ISO 9001:2008;
b) Reporting to top management on the performance of the Quality Management System, including
needs for improvement;
c) Ensure and promote awareness of customer requirements throughout the organization.
d) Liaison with external parties on matters relating to the Quality Management System.
5.5.3 Internal communication GO BACK
In line with Our Company’s policy of leadership through employee involvement, Our Company’s
personnel policies have established open communication throughout the organization.
The effectiveness of our quality management system is evident through Internal Audit results,
Corrective and Preventive Actions, and the departmental performance measures. Other than
confidential information, company and departmental performance measures are posted on bulletin
boards throughout Our Company. Internal Audit results, Corrective Actions and Preventive Actions
are shared at departmental meetings as appropriate.
CQP-001- MANAGEMENT RESPONSIBILITY
CQP-021- INTERNAL COMMUNICATION
HR-102 - POSITION DESCRIPTIONS
5.6 MANAGEMENT REVIEW
5.6.1 General
The company’s management, at planned intervals, reviews the Quality Management System to
ensure its continuing suitability, adequacy and effectiveness. The review includes evaluation of the
need for changes to quality management system, including quality policy and quality objectives.
5.6.2 Review Input
The ISO Management Representative and Departmental Head provide the following information for
Plant Operational Committee (POC):
 Result of Internal and External Audit

 Customer Feed Back
 Process Performance and Product Conformance
 Status of Corrective & Preventive Actions
 Follow up actions from previous management reviews
 Changes that could affect the quality management system
 Review of Quality Policy (after two years)
 Review of Corporate Quality Objectives
5.6.3 Review Output
Records shall include the output from the management review and shall include any decisions and
actions related to:
a) Improvement of effectiveness of quality management system and its processes;
b) Improvement of product related to customer requirements;
c) Resource needs;
d) Results of management reviews are recorded in the form of minutes of meeting;
CQP-001- MANAGEMENT RESPONSIBILITY
6.0 RESOURCE MANAGEMENT GO BACK

6.1 PROVISION OF RESOURCES
During planning and budgeting processes and as needed throughout the year, the Managing Director
and management team determine and ensure the appropriate resources are available to implement
and maintain the quality management system and continually improve its effectiveness and enhance
customer satisfaction by meeting or exceeding customer requirements.
 Human Resources
 Infrastructure
 Work Environment
6.2 HUMAN RESOURCES
6.2.1 General
Personnel performing work affecting product quality shall be competent based on appropriate
education, training, skills and experience.
6.2.2 Training Procedure
The minimum competencies required for each position at CCL Pharmaceuticals are defined in each
Position Description. Human Resources and Departmental Head and Supervisors are responsible for
ensuring position description is current.
Where otherwise qualified personnel require additional training or other action to meet the minimum
competency requirements, these needs are identified. The department provides task-specific training.
General training or education is provided or coordinated by Human Resources. The department or
Human Resources evaluate the effectiveness of training or other actions taken as appropriate.
The department generates records of task-specific training. Human Resources maintain records of all
training and education, skills and experience.
Departmental Heads are responsible for ensuring their employees are aware of the relevance and
importance of their activities and how they contribute to the achievement of the quality objectives.
DEV101 – TRAINING PROCEDURE
6.3 INFRASTRUCTURE GO BACK

CCL Pharmaceuticals provides the infrastructure necessary to achieve conformity to product
requirement. During the annual budgeting and strategic planning processes buildings, workspace,
and associated utilities are evaluated. When new personnel are added, Human resources coordinate
activities to ensure appropriate process equipment including hardware and software if required and
supporting services such as telephones etcare available based on information provided on the
personnel requisition.
Our Company provides the infrastructure necessary to achieve conformity to product requirements.
6.4 WORK ENVIRONMENT
The company has determined and manages the work environment needed to achieve conformity to
product. This includes suitable lighting, ventilation, cleanliness, workspace, temperature, Relative
Humidity…etc
CQP-017- INFRASTRUCTURE AND WORK ENVIRONMENT
7.0 PRODUCT REALIZATION

7.1 PLANNING OF PRODUCT REALIZATION
The company has planned and developed the processes needed to provide our customers products
and services that meet their requirements. The results of this planning are the processes and
procedures defined in our Quality Management System documentation. These processes and
procedures including the quality objective and requirements for our products, the required
verification, validation, monitoring, inspection and test activities specific to our products and the
criteria for product acceptance verification. The records needed to provide evidence that these
processes and resulting product meet requirement are defined in the procedures. Consideration is
given for the need to establish processes, documents and obtain resources specific to new product as
they are developed or during contract review.
7.2. CUSTOMER RELATED PROCESSES
7.2.1 Determination of Requirements Related to the Product
The requirements related to products consist of three categories, which include:
1. Requirements specified by the customer, including the requirements for delivery and post-delivery
activities.
2. Requirements not stated by the customer but necessary for specific use or known and intended use
3. Statutory and regulatory requirements related to the product.
7.2.2 Review of Requirements Related to the Product

The requirements related to the product are reviewed by company. This review is conducted prior to
the company’s commitment to supply a product to the customer and ensures that:
a) Product requirements are clearly defined;
b) Where the customer provides no written statement of requirement, the order requirements are
confirmed before acceptance;
c) Contract or order requirements differing from those previously expressed, e.g. in a tender or
quotation, are resolved;
d) The company has the ability to meet the requirements for the product.
e) The results of reviews and subsequent follow-up actions are recorded.
f) The company ensures that relevant documentation is amended on changes in product requirements.
g) The changed requirements are communicated to all relevant personnel.
The requirements specified by customer are determined through his inquiries, contracts, and orders.
Sales & Marketing Division is responsible for handling inquiries and orders.
The requirements not stated by customer but necessary for specific use or known and intended use
are determined through customer surveys, feedback and complaints. This information is also used for
monitoring the customer satisfaction.
The legal and regulatory requirements related to product are identified by contacting the related
regulatory bodies. Any such applicable requirements are recorded and verified for its
implementation.
Product and material related requirements are determined internally through Procedure for Design
Control and referring to Pharmacopoeia. These specifications are maintained by Quality Assurance
Department.
7.2.3 Customer Communication
The company has defined and implemented effective liaison with customers, with the aim of meeting
customer requirements. The company has defined communication requirements relating to:
a) Product information;
b) Enquiries, contracts and order handling, including amendments;
c) Customer complaints and their feedback

CQP-003 - CONTRACT REVIEW
CQP-020 - LEGAL & REGULATORY REQUIREMENTS
CQP-019 - CUSTOMER SURVEYS/FEEDBACK
CQP-022 - CUSTOMER COMPLAINTS
7.3 DESIGN AND DEVELOPMENT GO BACK

The design phase is the most important phase in the life cycle of a product. The inherent quality,
effectiveness, safety and customer satisfaction of the product are established during this phase.
To ensure that specified requirements are met, the following activities are applicable for the design
project.
7.3.1 Design and Development Planning
The design and development of products is planned and controlled.
The design and development planning includes:
 The design and development stages
 The review, verification and validation at appropriate design and development stages
 The responsibilities and authorities for design and development
The interfaces among different organizational functions and groups are defined and properly
managed to ensure effective communication and clear assignment of responsibility.
7.3.2 Design and Development Inputs
Design Inputs requirements that are applicable to the product shall be identified, documented &
reviewed for adequacy. They shall be complete, unambiguous, and not in conflict with each other
and records related to design and development inputs are maintained.
Design and Development inputs include:
 Technical Pharmaceutical literature
 Applicable statutory and regulatory requirements
 Market/Customer input from Sales & Marketing division
 Other requirements essentials for design and development
7.3.3 Design and Development Output
Design and development output will be provided in a form that enables verification against the
design and development input. This may be in the form of technical specification, documents,
drawings, bill of materials, etc.
Design and development output shall be approved before release. The review shall ensure:
 The output meets the requirements of design and development inputs.
 Appropriate information for purchasing, production and provision of services is available.
 Product acceptance criteria are identified or referenced.
 The characteristics of the product that is essential for its safe and proper use are specified.
7.3.4 Design and Development Review GO BACK
At the appropriate stages defined in the design and development plan, systematic reviews of design
and development shall be performed:
 To evaluate the ability of the results of design and development to meet requirement
 To identify any problems and propose necessary actions
Design reviews are conducted by representatives of all functions concerned with design and
development stages being reviewed. Records of the results of the reviews and any necessary actions
shall be maintained.
7.3.5 Design and Development Verification

Design and development verification confirms, by objective evidence, that the specified design
requirements have been met. Verification shall be performed at the stages identified in the Design
and Development Plan. One or more of the following methods may be acceptable for design
Verification:
 Performing alternate calculations
 Comparing a new design with a similar proven design
 By tests or demonstrations
 Reviewing the Design Stage Documents before release
Records of the results of the verifications and any necessary actions shall be maintained.
7.3.6 Design Validation
After verification activities are done, design and development is completed, the validation of design
is performed, as per design planning, to ensure that the resulting product is capable of meeting the
requirements for the specified application or intended use.
The design is validated at the final stage after the successful verification with respect to the product
solidarity, stability, reliability, pharmacological efficacy, availability of starting materials, work
center capacity, market share, facilities for testing and inspection, storage and handling.
Records of validation activities are maintained.
7.3.7 Design Changes
If changes in design are identified, the changes shall be reviewed, verified and validated as
appropriate, and approved before implementation.
The review of design and development changes shall include evaluation of the effect of the changes
on constituent parts and product already delivered, records of the results of the review of changes
and any necessary action shall be maintained.
CQP-004 - DESIGN & DEVELOPMENT
7.4 PURCHASING GO BACK
7.4.1 Purchasing process
The company controls its purchasing processes to ensure purchased product and/or service(s)
conform to purchase requirements. The type and extent of control is dependent on the effect of the
purchased product and/or service(s) upon final product.
A supplier evaluation committee has been established which evaluates and selects suppliers based
upon their ability to supply product and/or services in accordance with company’s requirements.
Evaluation, re-evaluation and selection criteria for suppliers are established. The results of
evaluations and subsequent follow-up actions are recorded.
7.4.2 Purchasing information
Our Company uses purchase orders (PO’s) to describe the product to be purchased, including where
appropriate:
 Requirements for approval of product, procedures, processes and equipment
 Requirements for qualification of personnel
 Quality management system requirements
The Purchasing Department is responsible for ensuring the adequacy of specified purchase
requirements before their communication to the supplier.
Records of purchasing activities are maintained.
7.4.3 Verification of purchased product
The company determines and implements the inspection or other activities necessary for ensuring
that purchased product meets the specified requirements.
Where the company or the company’s customer proposes to perform verification activities at the
supplier's premises, the company specifies the required verification arrangements and method of
product release in the purchasing documentation.
PRO-101 - PROCUREMENT
CQP-009 - INSPECTION AND TEST STATUS
CQP-002 - PROCESS CONTROL
7.5 PRODUCTION AND SERVICE PROVISION GO BACK
7.5.1 Control of Production and Service Provision
Our Company plans and carries out production and service activities under controlled conditions.
Controlled conditions shall include, as applicable:
 The availability of information that describes the characteristics of the product
 The availability of work instructions, as necessary
 The use of suitable equipment
 The availability and use of monitoring and measuring devices
 The implementation of monitoring and measurement
 The implementation of release, delivery and post-delivery activities
Manufacturing Procedures, Inspection Procedures, and Service Procedures define Our Companies
plan for manufacturing and service. These procedures provide detailed planning of all phases
including the methods and equipment to be used and workmanship criteria. This detailed planning
will be documented for each product in the form of work instructions, drawings or specifications.
7.5.2 Validation of Processes for Production and Service Provision

The company determines and validates any processes where the resulting output cannot be readily or
economically verified by subsequent monitoring, inspection or testing.
7.5.3 Identification and Traceability
Identification is the representation of products or its components through numbers or codes. Products
are identified by brand names and registration numbers to correlate to corresponding specifications
and other technical documents.
Traceability is the ability to trace back the manufacturing history of products to identify the root
causes in case of customer complaints or product recall. Traceability is ensured by identifying batch
numbers and manufacturing date to products manufactured in the same period under similar
conditions.
The status or products after inspection and testing activities is identified through release & rejected
stickers, tags, labels, etc. to avoid mix-up between conforming and nonconforming products, and to
ensure that only product that has passed inspection is used and dispatched.
7.5.4 Customer Property GO BACK
There is no customer property that is used in the manufacturing of company’s products. Hence this
clause is not applicable.
7.5.5 Preservation of Product
The company ensures that during internal processing and final delivery of product or services to the
intended destination, the conformity of product with requirements is maintained thorugh out the shelf
life. This includes:
 Packaging
 Storage
 Preservation
 Handling
CQO-002- PROCESS CONTROL
CQP-009- INSPECTION AND TEST STATUS
CQP-007- IDENTIFICATION AND TRACEABILITY
CQP-012- HANDLING, STORAGE, PACKAGING, PRESERVATION AND DELIVERY
7.6 CONTROL OF MONITORING AND MEASURING DEVICES GO BACK
All measuring and monitoring equipment used for verification of products and for monitoring
processes are regularly calibrated and / or checked. A list of such equipment is maintained, List of
Calibration Lab. Instruments.
The equipment is calibrated in accordance with an approved written calibration schedule (List of
Inspection Measuring & Test Equipment). Calibration standards are traceable to recognized
national / international standards. The company 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 with a, stickers, marking or other suitable
identification to indicate their calibration status, 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. All equipment is safeguarded to avoid unauthorized
adjustments and calibration.
7.6.1 Calibration Activities
The Engineering Department is responsible for the Calibration activities at Our Company. They are
responsible for establishing and maintaining processes to ensure that monitoring and measurement
can be carried out and is carried out in a manner that is consistent with the monitoring and
measurement requirements, taking into account the tolerances required for the measurement and the
accuracy and precision of the instrument.
Where necessary to ensure valid results, measuring equipment shall be included in the calibration
program. The calibration program ensures measuring equipment is:
 Calibrated or verified at specified intervals, or prior to use, against
measurement standards traceable to international or national measurement standards; where no such
standards exist, the basis used for calibration or verification shall be recorded;
 Adjusted or re-adjusted as necessary
 Identified to enable the calibration status to be determined
 Safeguarded from adjustments that would invalidate the measurement result
 Protected from damage and deterioration during handling, maintenance and storage
In addition, the Quality Department shall assess and record the validity of the previous measuring
results when the equipment is found not to conform to requirements. The organization shall take
appropriate action on the equipment and any product affected. Records of the results of calibration
and verification shall be maintained.
When used in the monitoring and measurement of specified requirements, the ability of computer
software to satisfy the intended application shall be confirmed. This shall be undertaken before
initial use and reconfirmed as necessary. Records of this confirmation shall be maintained with
calibrations records through the use of the Control of Monitoring & Measuring Devices procedure.
CQP-008 - CONTROL OF INSPECTION, MEASURING AND TEST EQUIPMENT
8.0 MEASUREMENT, ANALYSIS, AND IMPROVEMENT GO BACK

8.1 GENERAL
As part of our quality system and our commitment to continuous improvement, CCL
Pharmaceuticals has planned and implemented the monitoring, measurement, analysis and
improvement processes needed to demonstrate conformity to the product, to ensure conformity of the
quality management system, and to continually improve the effectiveness of the quality management
system. This includes determination of applicable methods, including statistical techniques, and the
extent of their use, with the intention of converting data to information and presenting it in a suitable
format for decision-making
8.2 MONITORING AND MEASUREMENT

The measurement and monitoring activities address the following areas:
 Measurement and monitoring of customer satisfaction

 Measurement and monitoring of quality system through quality audits
 Measurement and monitoring of processes
 Measurement and monitoring of products
8.2.1 Customer Satisfaction
The company has determined and established processes for monitoring information on customer
satisfaction and/or dissatisfaction to assess whether the company has met the customer requirements.
Regular feedback is taken from customer through feedback questionnaire and visits, which is
compiled and analyzed to monitor the customer satisfaction level.
8.2.2 Internal Audit
Company conducts internal audits at planned intervals to determine whether the quality management
system conforms to the planned arrangements for product realization, to the requirements of the ISO
9001:2008 standard, and to the quality management system requirements; and to determine if the
quality management system is effectively implemented and maintained.
The internal audit procedure details the requirements for the audit program including requirements
that the audit program shall be planned, taking into consideration the status and importance of the
processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope,
frequency and methods shall be defined. Selection of auditors and conduct the audits shall ensure
objectivity and impartiality of the audit process. Auditors shall not audit their own work.
The ISO Management Representative is responsible for the internal audit program. The
responsibilities and requirements for planning and conducting audits, and for reporting results and
maintaining records are further detailed in the internal audit procedure.
The management responsible for the area being audited shall ensure that actions are taken without
undue delay to eliminate detected nonconformities and their causes. Follow-up activities shall
include the verification of the actions taken and the reporting of verification results as indicated in
the corrective action procedure.
8.2.3 Monitoring and Measurement of Processes GO BACK
The company applies suitable methods for measurement and monitoring of processes necessary to
meet customer requirements and to demonstrate the processes continuing ability to satisfy its
intended purpose.
The measurement and monitoring of processes is done by:
 Defining and monitoring the process parameters and process instructions
 Verifying compliance with parameters and written instructions
 Conducting audits to verify compliance
 Identifying and applying statistical tools, where required
In case of non-conformance with the planned result, correction and corrective action are taken to
ensure conformity of product.
8.2.4 Monitoring and Measurement of Product

The company applies suitable methods for measurement and monitoring of the characteristics of the
product at the receiving, in-process and final stages to verify that requirements for the product are
met.
This monitoring and measurement of products are carried out at appropriate stages of the product
realization process in accordance with quality plan or other planned arrangements.
Evidence of implementation of required measurement and monitoring and conformance with the
acceptance criteria used is recorded.
Product does not proceed to next stage or is not dispatched until all specified activities have been
satisfactorily completed and the related documentation is available and authorized.
CQP-002- PROCESS CONTROL
CQP-008- CONTROL OF INSPECTION, MEASURING AND TEST EQUIPMENT
CQP-011- CORRECTIVE AND PREVENTIVE ACTION
CQP-014- INTERNAL QUALITY AUDIT
CQP-016- STATISTICAL TECHNIQUES
CQP-017- INFRASTRUCTURE AND WORK ENVIRONMENT
CQP-018- INSPECTION AND TESTING
CQP-019- CUSTOMER SURVEY AND FEEDBACK
8.3 CONTROL OF NONCONFORMING PRODUCT
The company ensures product that does not conform to requirements is controlled to prevent
unintended use or delivery. The controls and related responsibilities and authorities for dealing with
non-conforming products are defined and documented.
8.3.1 Nonconforming Product Actions GO BACK
The nonconforming products are dealt with in any of the following ways:
 Taking actions to eliminate the detected nonconformity (Rework)
 Rejecting and disposing off the nonconforming product
 Authorizing its use, release or acceptance by the relevant authority (accept-as-it)
 Returning to supplier (replacement)
Records of nature of nonconformity and any subsequent actions taken are maintained.
Any nonconforming product that has been corrected is subjected to re-verification to ensure
conformity to the requirements.
In case the nonconformity is detected after delivery, the company takes action appropriate to the
effects, or potential effects, of the nonconformity.
CQP-010 - CONTROL OF NON-CONFORMING PRODUCT
CQP-013 - CONTROL OF COMPANY QUALITY RECORDS
8.4 ANALYSIS OF DATA

8.4.1 Quality Management System Evaluation
The ISO Management Representative and departmental Head are responsible for determining,
collecting and analyzing appropriate data to demonstrate the suitability and effectiveness to the
quality management system and to evaluate where continual improvement of the effectiveness of the
quality management system can be made.
This shall include data generated as a result of monitoring and measurement and from other relevant
sources. The analysis of data shall provide information relating to:
a) Customer satisfaction and/or dissatisfaction;
b) Conformance conformity to product requirements;
c) Characteristics of processes and products and their trends;
d) Suppliers;
CQP-010 - CONTROL OF NON-CONFORMING PRODUCT
CQP-013 - CONTROL OF COMPANY QUALITY RECORDS
CQP-016 - STATISTICAL TECHNIQUES
CQP-017 - INFRASTRUCTURE AND WORK ENVIRONMENT
CQP-022 - CUSTOMER COMPLAINTS
8.5 IMPROVEMENT
8.5.1 Continual Improvement
The company continually strives to continually improve the effectiveness of quality management
system by:
 Reviewing the continual suitability of quality policy
 Defining and implementing the quality objectives and reviewing the achievement of quality
objectives
 Taking actions on audit results
 Taking actions on the results of data analysis
 Implementing corrective and preventive actions
 Taking decisions in management review on recommendations for improvement.
8.5.2 Corrective Action
The ISO Management Representative is responsible for managing the corrective action program. As
defined in the corrective action procedures, all concerned personnel are responsible for taking action
to eliminate the cause of nonconformities in order to prevent recurrence. Corrective actions shall be
appropriate to the effects of the nonconformities encountered.
The procedure for the corrective action process includes:
o Identification and review of nonconformities (including customer complaints);
o Determination of causes of nonconformities;
o Evaluation of the need for actions to ensure that nonconformities do not recur;
o Determination and Implementation of any actions necessary to ensure that nonconformities do
not recur;
o Recording results of actions taken;
o Follow-up to ensure corrective action taken is effective and recorded.
8.5.3 Preventive Action

The ISO Management Representative is responsible for managing the Preventive action program. As
defined in the preventive action procedure, all concerned personnel are responsible for taking action
to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive
actions shall be appropriate to the effects of the potential problem.
The Corrective and Preventive action Procedure defines requirement for:
o Identification of potential nonconformities and their causes;
o Determination and ensuring the Implementation of preventive action
o Recording of results of action taken;
o Review of preventive action taken is effective and recorded.
CQP-011 - CORRECTIVE AND PREVENTIVE ACTION
Quality Manual - Revision History
Pages
Revision Date of Amendment Description of changes
No.
The Quality Manual has been reviewed according to
QM-001 June 07, 2007 the latest requirement of ISO 9001:2000 All
The Quality Manual has been review due to iii, 1, 2, 3, 4, 5, 16,

QM-001-A October 22, 2009 recertification of new version of ISO9001:2008 20 and 21.
QM-001-B December 13, 2011 The Quality Manual has been reviewed by new Procedures CQP-
management and signed thereof. 001, CQP-002, CQP-
022,
QM-001-C April 25, 2012 The Quality Manual has been reviewed. All
QM-001-D May 11, 2015 Designations of prepared by,reviewed by and 1 and 10

approved by changed.
Quality Policy Changed
Page 20 of 30
SECTION V GO BACK
TERMS AND DEFINITIONS
(Reference ISO 9001:2008)
TERMS DEFINITIONS
TERMS RELATING TO QUALITY
Quality Ability of a set of inherent characteristics of a product, system or process
to fulfill requirements of customers and other interested parties.
Quality Requirement Requirement for inherent characteristics of a product, process or system
Customer Satisfaction Customer’s opinion of the degree to which a transaction has met the
customer’s needs and expectations
Capability Ability of an organization, system, or process to realize a product that
fulfils the requirements for that product
TERMS RELATING TO MANAGEMENT

Management System System to establish policy and objectives and to achieve those objectives
Quality Management System System to establish a quality policy and quality objectives and to achieve
those objectives
Quality Policy Overall intentions and direction of an organization related to quality as
formally expressed by the management.
Quality Objectives Something sought, or aimed for related to quality.
Quality Planning Part of quality management focused on setting quality objectives and
specifying necessary operational processes and related resources to fulfill
the quality objectives.
Quality Control Part of quality management, focused on fulfilling quality requirements
Quality Assurance Part of quality management, focused on providing confidence that quality
requirements are fulfilled
Quality Improvement Part of quality management, focused on increasing effectiveness and
efficiency
TERMS RELATING TO ORGANIZATION
Organizational Structure Orderly arrangement of responsibilities, authorities and relationships
between people
Work Environment Set of conditions under which a person operates
Customer Organization or person that receives a product
Supplier Organization or person that provides a product
Interested Property Person or group having an interest in the performance or success of an
organization
TERMS RELATING TO PROCESS AND PRODUCT
Process System of activities which uses resources to transform inputs into outputs
Product Result of a process
Service Intangible product that is the result of at least one activity performed at the
interface between the supplier and customer
Design and Development Set of processes that transforms requirements into specified characteristics
and into the specifications of the product realization process
TERMS RELATING TO CHARACTERISTIC
Quality Characteristics Inherent characteristics of a product, process, or system derived from a
requirement
Traceability Ability to trace the history, application or location of that which is under
consideration
TERMS RELATING TO CONFORMITY
Conformity Fulfillment of a requirement.
Non-conformity Non-fulfillment of a requirement.
Preventive Action Action taken to eliminate the causes of a potential non-conformity or other
potentially undesirable situation.
Corrective Action Action taken to eliminate the cause of a detected nonconformity or other
undesirable situation.
Correction Action taken to eliminate a detected nonconformity.
Concession Authorization to use or release a product that does not conform to the
specified requirements
Release Authorization to proceed to the next stage of a process
Repair Action taken to a non-conforming to make it acceptable for the intended
use
Rework Action taken on a non-conforming product to make it conform to the
requirements
Re-grade Alteration of the grade of a non-conforming product in order to make it
conformant with requirements differing from the initial ones
Scrap Action taken on a non-conforming product to preclude its originally
intended usage
TERMS RELATING TO DOCUMENT
Document Information and its support medium
Specification Document stating requirements
Guideline Document stating recommendations or suggestions
Quality Manual Document stating the quality management system of an organization
Quality Plan Document specifying the quality management system elements and the
resources to be applied in a specific case.
Procedure Specified way to perform an activity or a process.
Record Document stating results achieved or providing evidence of activities
performed
TERMS RELATING TO EXAMINATION
Objective Evidence Data supporting the existence or verity of something.
Inspection Conformity evaluation by observation and judgment accompanied as
appropriate by measurement, testing or gauging.
Verification Confirmation and provision of objective evidence that specified
requirements have been fulfilled.
Validation Confirmation and provision of objective evidence that the requirements for
a specific intended use or application have been fulfilled
TERMS RELATING TO AUDIT
Audit Systematic, independent and documented process for obtaining evidence
and evaluating it objectively to determine the extent to which the audit
criteria are fulfilled
Audit Programme Set of audits to be carried out during a planned timeframe
Audit Scope Extent and range of a given audit
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 Conclusions Outcome of an audit decided by the audit team after consideration of all the
audit findings
Auditee Organization being audited
Audit Team One or more auditors conducting an audit, one of whom is appointed as
leader
Auditor Person qualified and competent to conduct audits
I.1. TERMS RELATING TO QUALITY ASSURANCE FOR MEASUREMENT PROCESSES

Measurement Set of operations having the object of determining the value of a quantity
Measurement Process Set of interrelated resources, activities, and influences related to a

measurement
Measurement Control Set of operations necessary related to achieve metrological confirmation
System and continuous control of measurement processes
Measuring Equipment Instrument, measurement standard, reference material and/or auxiliary
apparatus necessary to implement a measurement process for carrying out a
specified and defined measurement
TERMS AND DEFINITIONS RELATED TO

GOOD MANUFACTURING PRACTICES (GMP)
Active Ingredients The component(s) intended to furnish pharmacological activity or other

desired effects in the diagnosis, treatment, preventive of diseases or to
affect the structure of any function in the body of human being.
Air Locks An enclosed space with two or more doors any one of which should
markedly be capable of being opened at any lines and which is interposed
between two or more rooms which they need to be enforced. An air lock
may be designed for and used by either personnel or material(s)
movement.
Aseptic Area / Rooms A room, suite of room or special area within a clean area designed,
constructed, received and used with the instruction of preventing micro-
biological contamination of the product.
Pyrogenic Any product(s) material(s), which is free from pyrogen.
Batch Number A distinctive combination of number(s) and letter(s) which identifies a
batch or lot and permits is history to be traced.
Batch Packaging Record / A document or set of documents recording the product quantities and
Document packaging materials used and the process carried out during the
packaging operation of a given batch with details of in-process controls.
It should be on a master packaging instructions sheet.
Batch A specified quantity of material produced by a defined and approved
procedure which have been manufactured and packed.
Batch Manufacturing Record A document stating the material(s) used and operations carried out during
processing of a given batch including details of in-process controls but
excluding packaging information.
Calibration The set of operations that establishes under specified conditions, the
relationship between values indicated by an instrument or measuring
system especially the weighing, recording, controlling or the values
represented by a material measure and the corresponding known values
of a reference standard and the limits for acceptance of the results of
measurement.
Critical Process The process that may cause variation in the quality of the pharmaceutical
product.
Cross Contamination The intermixing of a raw material, in-process or finished product(s) with
another raw material(s) or drug(s) during production.
Change Room A room or suit of room designed for the changing of cloth.
Computer Control The activity of receiving data and electronically generating information,
which is then, used either for some other activity.
De-ionized Water Purified water free from ions prepared by ion-exchange method.
Distilled Water Purified water prepared by simple distillation process or reverse osmosis.
Drug Ordinance A document issued by the Drug Registration Board set up under the
Drugs Act 1976 as a certificate of drug registration.
Emergency Process Any unplanned or accidental process change is emergency process
Deviations deviation.
Finished Product A medicinal product which has undergone all stages of manufacturing
and packaging operations.
Good Manufacturing The quality assurance aimed at ensuring that the products are consistently
Practices (GMP) manufactured in such as to achieve a quality appropriate to their intended
use. It is thus concerned with the incoming materials, in-process
products, finished products, operations and any other procedure, which
directly or indirectly influence the quality of product.
Internal Audit A complete appraisal of all or part of detailed operations to determine
any possible defects, errors or omission which contravene GMP or effect
product quality.
In-process Product Any material or product that must under go further manufacturing /
packaging / process.
Iodometry Oxidation, reduction titrations in which Iodine is used as an oxidant for
quantitative analysis.
In-Process Control Tests, checks and measurements made during the course of
manufacturing and packaging process to ensure that the resultant product
will comply with its specifications. Tests applied to the environment or
to equipment, as well as to the products in-process, may be regarded as
apart of in-process control.
Inactivation The process in which the chemical activity of the compound is lost and
the chemical compound responses nothing even activation energy is
reached.
Manufacture Means all operations of production, quality control, release, storage and
all released controls.
Master Formula Means a document or set of documents specifying the starting materials
with their quantities and packaging materials together with descriptions
of the procedure a specified quantity.
Material Handling All handling or materials and products such as receipt, sampling, storage,
labeling, dispensing, processing, packaging and distribution shall be done
in accordance with the written procedures, instructions and necessary
recorded.
Manufacturing Date The date at which the batch manufacturing is started.
Monitoring To monitor a process or a situation is to carry out repeated measurements
on observations of one or more characteristic whether or not it is
conforming intermittently and not necessarily performed on every batch.
New Drug A drug that has not been commonly sold to the public and is introduced
for the first time.
Non-Pathogenic Means the class of microorganisms not capable of causing disease.
Production All operations Involved in the preparations of a pharmaceutical product,
from the receipt of the raw materials, through processing and packaging
to its completion as the finished product.
Packaging Packaging refers to all operations including filling and labeling which is
ready for release by QA department.
Packaging Material Any material used in the packaging of a product. There are various
categories of packaging material:
Packaging materials which come in contact with products.
Printed packaging materials.
Auxiliary packaging materials.
Ph Negative log of hydrogen ion concentration in a solution is called PH.
Product Recall It is system to promptly and effectively recall from the market, the
product known or suspected to be defective in quality.
Quarantine Area The status of a material that is set apart and that is not available for use
until released by the quality assurance department.
Retail Price The price at which the product is sold at the pharmacy shops & medical
stores.
Re-Processing The reworking of all or part of a batch of product of an unacceptable
quality form a refined stage of production so that its quality may be
regained up to acceptable standard by one or more additional operations.
Returned Product Means finished product sent back to the manufacturer or distributor.
Raw Material Any substance used in the manufacturing of product excluding the
packaging material.
Retain Samples The sample (s) of raw material and every batch finished product (s)
retained the quality assurance department as reference for future.
Relative Humidity The moisture concentration with respect to some standard or known
moisture controls.
Regulatory Audit Audit carried out by various external regulatory bodies against the
relevant regulations for the manufacture and supply of the
pharmaceutical products.
Reconciliation A comparison, making due allowance for normal variation between the
amount of product or materials theoretically produced or used and the
amount actually produced or used.
Retrospective Validation This is basically summarizing experience of all the test results are
meeting all the specifications it will give confidence of using the system
for manufacturing purpose.
Standard Operating A written approved procedure having instructions for performing
Procedures (SOPs) operations not necessary specific to given material or may be in general
e.g. equipment operations, cleaning, cleaning of premises, manufacturing
and packaging operation.
SOPs For Analysis A detailed description of procedure to be followed in performing tests for
confirming the presence of the active ingredients(s) in the dosage form
according to the specifications.
Specifications A document established by the manufacturer giving a description of an
incoming material i.e, raw material or packaging material, in process or
finished product in terms of its chemical , physical, microbiological
potency, sterility, pyrogen characters. A specification normally includes
descriptive clauses and numerical clauses that later stating standards and
permitted tolerance.
Shelf-Life (exp. Date) The time period, as determined by the procedure, during which the
product retains its efficiency within its defined specifications.
SOPs for Equipment A written procedure having direct effect on the product quality but giving
/Machinery comprehensive instruction for operating machinery / equipment and
represents full operating instructions.
Status The classification of any material, product container or machine in
relation to their acceptance or otherwise, for further use, processing or
distribution e.g, quarantined, sampled, released rejected, cleaned, not to
be used, under repair, work completed etc.
Sterility The complete absence of living organisms.
Sterile Sterile means devoid of any microbial contamination.
Sterile Products The product which contains no living organism and hence pyrogenic
endotoxins.
Spectrophotometer Measurement of the concentration of the active ingredients(s) by the
measurement of light absorption by them
Stability Study A study to establish expiry dates and shelf – life specifications related to
storage conditions.
Thermolabile Means the materials that are decomposed/damaged/changed physically or
chemically at temperatures higher than specified temperature.
Tap water Water got from the tap and subjected to purification technique(s).
Unauthorized Entry Access to the production and warehouse premises shall be restricted to
Prohibited authorized personnel.
Validation Means the documented act of providing that any procedure, proves
equipment, material, activity or system control correctly and actually
heads to the expected results.
Weighing Area A separate area designated for weighing of raw material with provisions
for dust control.
Yield Deviations Any significant deviation from the approved deviation yield shall be
recorded or investigated.
Authorized Person “Authorized Person” means a person responsible for the release of
batches of product for sale.
Basic Manufacture “Basic Manufacture” means manufacture of a drug from basic raw
material to a product which is ready for use as a starting
Batch Numbering System “Batch Numbering system” means a standard operating procedure
describing the details of the batch numbering.
Biological Agents “Biological Agents” mean micro-organisms, including genetically
engineered micro-organisms, cell cultures & end parasites, Whether
parasites or not.
Bulk Product “Bulk Product” means any product that has been completed all
processing stages up to but not including final packaging.
Clean Area “Clean Area” means area with defined environmental control of
particulate and microbial contamination, constructed & used in such a
way as to reduce or eliminate introduction, generation and retention of
contaminants within the area.
Compounding “Compounding” means scientific combination of two or more ingredients
with a view to make a finished drug.
Consignment or Delivery “Consignment or Delivery” means the quantity of starting material, or of

a drug product, made by one manufacturer and supplied at one time in
response to a particular request or order, a consignment may comprise
one or more packages or containers & may include material belonging to
more than one batch.
Form “Form” means a form set forth in schedule A.
Formulation “Formulation” means all operations involved in converting a drug into a
final pharmaceutical dosage form ready for used as a finished drug
including compounding, processing formulating, filling, packing,
finishing, labeling & other like processing.
Half Finished Product “Half Finished Product” means any material or mixture of materials that
has to materials that has to undergo further manufacture.
Intermediate Product “Intermediate Product” means partly processed material that must
undergo further manufacturing steps before it becomes a bulk product.
Large-Volume Parenterals “Large Volume Parenterals” means sterile solution intended for
Parenterals application with a volume of more than 100 ml in one
container of the finished dosage form.
Manufacturer “Manufacturer” means all operations of production, quality control,
release, storage & the related controls.
Marketing Authorization “Marketing Authorization” means a document, issued by the Drug
Registration Board Set up under the Drug Act, 1976, as a certificate of
drug registration.
Ordinance “Ordinance” means the Drugs Ordinance, 1976 (IV of 1976).
Pharmaceutical Product “Pharmaceutical Product” means any drug intended for human use or
veterinary use presented in its finished dosage form or as a starting
material for use in such a dosage form.
Processing Instructions or “Processing Instructions or Procedure” means as defined in this section.
Procedures
Purity “Purity” means the degree to which other chemical or biological entities
are present in any substance.
Quality Assurance “Quality Assurance” means the totality of the arrangements made with
the object of ensuring that pharmaceutical products are of the quality
required for their intended use & so incorporates good manufacturing
practices, Quality Control & other factors including product design &
development & good laboratory practices.
Quality Control “Quality Control” means the part of good manufacturing practices
concerned with sampling, specifications, & testing as well as the
organization, documentation, & release procedure which ensure that the
necessary & relevant tests are actually carried out & that materials are
not released for use, nor finished products released for sale or supply
until their quantity for has been judged to be satisfactory & it is involved
in all decisions concerning of the quality of the product.
Recovery or Blending “Recovery or Blending” means the introduction of all or part of previous
batches, or of redistilled solvents & similar products, of the required
quality into another batch at a defined stage of manufacture.
Retail Sale “Retail Sale” means a sale other than wholesale.
Schedule “Schedule” means schedule to these rules.

Semi-Basic Manufacture “Semi-Basic Manufacture” means manufacture from an intermediate
substance of a drug to be used as a starting material for the formulation
of a finished drug or to be used for repacking.
Starting Material “Starting Material” means a substance used in the production of a
pharmaceutical product but excluding packaging materials.
System “System” means a regulated pattern of interacting activities &
techniques, which are united to form an organized whole.
Wholesale “Wholesale” means sale to person who purchase for the purpose of
selling again & includes sale to hospital or dispensary, or to medical,
educational or research institute.
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ISO 9001 QMS CCL Pharmaceuticals

Document No.: QM-001-D Replaces: QM- 001-C

The quality manual establishes and states the policies governing

CCL Pharmaceuticals (Pvt.) Ltd.

7.0 PRODUCT REALIZATION…………………………………………………………8 13

8.4.1 Quality Management System Evaluation………………………………………………18

List of Referenced Procedures

1.0 PURPOSE: GO BACK

3.0 RELATION TO ISO 9001:2008

4.0 OUR COMPANY QUALITY MANAGEMENT SYSTEM

Table 1 General Process Flowchart

4.2 DOCUMENTATION REQUIREMENTS GO BACK

4.2.2 Quality Manual

The procedure for control of documents ensures that:

5.0 MANAGEMENT RESPONSIBILITY

5.3 QUALITY POLICY

5.5 RESPONSIBILITY, AUTHORITY, AND COMMUNICATION

 Result of Internal and External Audit

6.0 RESOURCE MANAGEMENT GO BACK

6.3 INFRASTRUCTURE GO BACK

CQP-017- INFRASTRUCTURE AND WORK ENVIRONMENT

7.0 PRODUCT REALIZATION

7.2.2 Review of Requirements Related to the Product

7.2.4 Referenced Procedures:

7.3 DESIGN AND DEVELOPMENT GO BACK

7.3.5 Design and Development Verification

7.3.7 Design Changes

7.5.2 Validation of Processes for Production and Service Provision

8.0 MEASUREMENT, ANALYSIS, AND IMPROVEMENT GO BACK

8.2 MONITORING AND MEASUREMENT

 Measurement and monitoring of customer satisfaction

8.2.4 Monitoring and Measurement of Product

8.4 ANALYSIS OF DATA

8.5.3 Preventive Action

Quality Manual - Revision History

The Quality Manual has been review due to iii, 1, 2, 3, 4, 5, 16,

QM-001-D May 11, 2015 Designations of prepared by,reviewed by and 1 and 10

TERMS RELATING TO MANAGEMENT

Audit Scope Extent and range of a given audit

I.1. TERMS RELATING TO QUALITY ASSURANCE FOR MEASUREMENT PROCESSES

Measurement Process Set of interrelated resources, activities, and influences related to a

TERMS AND DEFINITIONS RELATED TO

Active Ingredients The component(s) intended to furnish pharmacological activity or other

Consignment or Delivery “Consignment or Delivery” means the quantity of starting material, or of

Schedule “Schedule” means schedule to these rules.

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