CGMP 1673704816

cGMP’s FOR
PHARMACEUTICAL
MANUFACTURING
Arvind Kumar Srivastava , Dy. Manager

OBJECTIVE
1. To understand ---------------
 where the regulations come from,
 who has enforcement authority,
 and why you need to comply,

What are cGMPs?
 Current Good Manufacturing Practices.
 It is set of Rule to complies the Drug substance and Drug Products with
standard quality by the different Regulatory Authority.
 Good manufacturing practice (GMP) is a system for ensuring that products
are consistently produced and controlled according to quality standards. It is
designed to minimize the risks involved in any pharmaceutical production
that cannot be eliminated through testing the final product.

What are cGMPs?
….. that part of Quality Assurance which Quality Assurance
ensures that products are consistently

produced and controlled to the quality
standards appropriate to their use. GMP is GMP
Quality
Control
an integral part of Quality Assurance

What are cGMPs?
cGMP are enforced by the different – different regulated authority of different country and the cGMP
Guidelines are as below -----
 cGMP as per Schedule M
 cGMP as per WHO
 cGMP as per MHRA
 cGMP as per TGA
 cGMP as per USFDA

 cGMP as per ICH Guideline
 cGMP as per PICS
 cGMP as per EU

Why GMP?
1. To ensure safety
2. To ensure purity
3. To ensure effectiveness
• Poor quality medicines are only a health hazard and may be lethal to the consumers.
• A poor quality medicine may contain toxic substances that have been unintentionally
added.
• A medicine that contains little or none of the claimed ingredient will not have the
intended therapeutic effect.

What are the Benefits of cGMPs?
 Ensures that products are safe for humans use
 Maintains Manufacturing Consistency.
 Prevent /control Contamination and Cross-Contamination

Minimizes Potency variation of drugs
Prevents side effects

 Prevent toxicity due to variations in drug content and potency
 Prevents mislabeling and adulteration
 Reduces / Prevents Errors
 Satisfied Customers
 Company Image & Reputation
Who is responsible for GMP?

TRUST

ELEMENTS OF GMP
1. Premises
2. Equipment
3. Personnel
4. Materials
5.Documentation
6. Production
7. Quality control
8. Complaints
9. Product recall
10. Sanitation and Hygiene
11. Self inspection

GMP PREMISES
INTRODUCTION

GENERAL PRINCIPLE OF PREMISES
The location, layout and design of buildings should be suitable for the intended operations
and should minimise the risk of cross contamination and errors during all aspects of
manufacture, filling and packaging.
They should allow effective cleaning and maintenance in order to avoid build up of dust or
dirt, and any adverse effect on the product or the surrounding environment.
SCOPE
Applies to all premises related to the
production of pharmaceutical products.

DESIGN
1. Facilities should be designed for:
 logical flow of materials and people
 adequacy of working space and logical positioning of equipment
 smooth/crack-free/easy to clean interior surfaces
2. Sterile Production areas should be separated from others
 non-hazardous products can share premises provided that care be applied to prevent
cross contamination and risk of mix-up.

PREMISES AREA
There should be defined areas or other control systems for the following activities
ANCILLARY AREAS Rest and Refreshment Rooms , Gowning/ Change Room , changing and storing clothes and
for washing , toilet , Maintenance workshops
STORAGE AREAS Storage Areas for Starting and Packaging Materials, Intermediates, Bulk and Finished
Products, Products in Quarantine, and Released, Rejected, Returned or Recalled Products.
WEIGHING AREAS Sampling , Weighing / dispensing
PRODUCTION AREAS Processing, Equipment Washing, Storage of Cleaned Equipment
QUALITY CONTROL AREAS

DESCRIPTION OF DESIGN ,
LAYOUT & CONSTRUCTION

FLOORS , WALLS & CEILINGS
• walls, floors and ceilings should be smooth and free from cracks and open joints, should not
shed particulate matter, and should permit easy and effective cleaning

FLOORS
 Solid concrete for warehouse
 Solid concrete with epoxy is
suitable for processing areas as
it has a non- porous non skid
surface and retards bacterial
growth.

JOINTS & FRAMES
The design of joints and frames should be such that cleaning and sanitation can be done
easier
the joints of all surfaces the designs of windows and the way they fit into the frames

VENTILATION
Air should be appropriately filtered specifically in the processing and filling areas.
 One pass filtration air or circulation for wet, non-powdered and dry preparations.
 Powdered product should have a dust collection system installed.

STORAGE AREA (1)
Quarantine, and Released, Rejected, Returned or Recalled
Products.
Storage areas should be of sufficient capacity to allow orderly storage of various categories of
materials and products with proper segregation.
Status Labeling of materials should be observed.
STORAGE AREA (2)
Storage of toxic substance Returned / recalled products Printed packaging materials
Segregation Should be Provided for the Storage of Rejected, Recalled, or

Returned Materials or Products.

STORAGE AREA (3)
Receiving and Dispatch bays should be separated and should protect materials and products from the weather.
Receiving areas should be Designed and Equipped to allow Containers of Incoming Materials to be Cleaned, if
Necessary, before storage.

FLAMMABLE WAREHOUSE
alcohol and flammable warehouse can be located in a separate location, with good
ventilation, fenced, locked, This warehouse should be indicated by inflammable and sufficient
safety signs.`
QUARANTINE & REJECTED AREAS
Quarantine status is ensured by

storage in separate areas, these
areas must be clearly marked and
their access restricted to
authorized
personnel. Any system replacing
the physical quarantine should
give
equivalent security.

QUARANTINE & REJECTED AREAS
Reject area should be kept
under lock and key.

SAMPLING
There should normally be a
separate sampling area for starting
materials.
If sampling is performed in the
storage area, it should be
conducted in such a way as to
prevent contamination or cross-
contamination.

WEIGHING & DISPENSING
The weighing of starting materials should be carried out in a separate

weighing area designed for that use with provisions for dust control.
PROCESSING AREA
Adequate working space should :
• permit the orderly & logical

positioning of equipment and
materials to minimize the risk
of confusion
• avoid cross contamination and

reduce the risk of wrong
application of any of the
manufacturing or control
steps.
PROCESSING AREA INTERIOR (1)
 Smooth, cleanable, easy to
maintain
 Covings where floor meets walls

may be observed.
 Recessed light fittings where

appropriate.

PROCESSING AREA INTERIOR
Drains should be of adequate size and designed
and equipped to prevent back-flow in the
Production area or Processing area.

PROCESSING AREA INTERIOR
Pipework , Light Fittings, Ventilation Points and other services should be designed and sited to avoid the
creation of recesses that are difficult to clean. As far as possible, for maintenance purposes, they should be
accessible from outside the manufacturing areas.
PACKAGING AREA
Premises for the packaging of

pharmaceutical products should be
specifically designed and laid out so as
to Avoid Mix Ups, Contamination
or Cross-Contamination.
STORAGE OF CLEAN EQUIPMENT
A separate room may be
needed for storing clean, idle
equipment which should be
kept dry at all times.
Proper storing of hoses

allowing them to dry
should also be observed
to prevent retention of Cupboard for clean
equipments
liquid.

CHANGING ROOM
Store working shoes separately.

 Keep gowns in cabinet to avoid dirt and dust.
 Soap for hand cleaning must be installed near the sink.
Paper towels or hand drier should be provided whichever
is suitable.
QC LABORATORY
QC laboratories should be separated from production areas. Areas where
biological, microbiological or radioisotope test methods are employed should be
separated from each other.
There should be adequate suitable
storage space for Samples, Reference
Standards (if necessary, with
cooling), Solvents, Reagents and
Records.

QC LABORATORY
Reference Standard Laboratory Apparatus
QC lab should be designed Sufficient
space should be given to avoid mix ups

Record Cupboard Reagent & Solvent
and cross contamination.
GMP EQUIPMENT
INTRODUCTION
Each manufacturer should assure that production equipment and quality control
measurement equipment are:
 Suitable for the Intended Use.
 Capable of producing Valid Results.
 Operated by Trained Employees; and
 Properly Calibrated versus a Suitable Standard.

GENERAL REQUIREMENTS

DESIGN & CONSTRUCTION (1)
1.Surfaces must not be:
 Reactive
 Additive
 Adsorptive
2. Easily cleanable
3. Must not affect the product through leaking valves, inappropriate maintenance, etc.

PIPES & PIPELINES (1)
Fixed pipelines for the transfer of products and materials should :
🖙 be clearly labelled
🖙 indicate contents
🖙 show direction of flow
 
PIPES & PIPELINES (2)
Water, steam, pressure and vacuum lines where applicable
should be:
 Easily accessible
 Clearly identified
 Instrument Monitoring Control
 The material quality and quantity that uses piping

system should be monitored and checked
periodically.
 Pipelines for hazardous gas and liquid installation…
 should be clearly labeled
 and pipe connections should use the right materials
SAFETY DEVICES
All safety and regulator devices should be checked and calibrated regularly
Air pressure regulator Pressure gauge & release

valve Control panel

LOCATION & INSTALLATION (1)
1. Avoid crowding.
2. Properly identified.
3. Easily accessible during all phases of operation.

Equipment Layout and Design must Aim:
to minimize risks of error to permit effective cleaning
to permit effective maintenance
And to avoid:
cross-contamination
dust and dirt build-up
any adverse effect on the quality of products
Equipment must be installed to:
minimize risks of error
minimize risks of contamination
Defective equipment should be removed from production and QC areas.
Current drawings of critical equipment and support systems should be maintained.

FLEXIBLE HOSES
 The transfer system of liquid
product may be through flexible
hoses made of suitable material and
compatible with the product used,
cleaning &, disinfecting agents and
steam.
 It should be clearly identified.

TYPE OF MATERIALS USED
Most of the pipelines should be used with Stainless Steel 316L as it is stable
1- when in contact with the materials, 2- during hot sanitation & disinfection.

MAINTENANCE SCHEDULE OF EQUIPMENT
A manufacturer should establish schedules to maintain, clean, and adjust equipment used
in the manufacture of pharmaceutical products.
To maintain, clean, or adjust equipment, the manufacturer should:
 have a written schedule;
 have special instruction, where adjustment is necessary to maintain proper operation;
 document the maintenance activities;
 check periodically;
 audit the activities and document the inspection results.

CALIBRATION
 The GMP calibration requirements is to assure adequate and
continuous performance of measurement equipment with respect to
accuracy and precision.
 The equipment should be calibrated according to written procedures

that include specific limits for accuracy and precision. All results should
be documented.
 Proper and periodic calibration will assure that the selected equipment
continues to have the desired accuracy

Good Practices In
Production
INTRODUCTION

Production operations must follow clearly defined procedures in accordance with manufacturing and
marketing authorizations.
Access to production premises should be restricted to authorized personnel.
In-process controls are usually performed within the production area.

GOOD PRACTICES IN PRODUCTION
PROCESSING OPERATIONS PACKAGING OPERATIONS

PRODUCTION MAPPING
Weighing
Production operations must follow clearly
defined procedures in accordance with Raw material
Preparation
approved specifications, with the objective
of obtaining products of desired quality.
Production activities start from :

Bulk storage
 - preparation of raw materials Processing
 - weighing of raw materials

 - mixing & bulk preparation
 - filling and packaging Delivery to
Filling & packing warehouse
to obtain finished products that can be
released to the market.
PROCESSING GUIDANCE (1)
There are several guidelines that should be followed prior, during and after each production activities. These
are:
 Area clearance or lines clearance should be done, to avoid mix up of starting materials or finished products
 In-process and environmental controls should be carried out and recorded.
 Failure of equipment or services should be monitored and only equipments in good condition should be
available in the production area.
 Cleaning procedures should be written and approved
 Containers should be cleaned prior to use
 Any deviation from requirements and expected result should be recorded and investigated prior to start of
production and prior to release of the finished product

PROCESSING GUIDANCE (2)
 Any significant deviation from the expected yield should be recorded and investigated.
 Checks should be carried out to ensure that pipelines and other pieces of equipment used for the
transportation of products from one area to another are connected in a correct manner.
 Measuring, weighing, recording, and control equipment should be serviced and calibrated at pre-
specified intervals and records are maintained.
 Repair and maintenance operations should not present any hazard to the quality of the
products.

LINE CLEARANCE
 1- line clearance should be done prior to processing and filling operations
 2- prepare a clearance checklist for each operation
 3- material from previous batch should be removed from the line
 4- filling machine should be connected to the right outlet of the bulk storage tank
 5- number of personnel should be enough to operate the line
 each personnel has clear understanding of their roles and responsibilities in the processing or filling
operation
 6- processing line should be clearly identified and labeled with the name of the product and batch number
 7- filling lines should be physically identified with the product name, size, batch no, and if needed the
destination of products

IN-PROCESS CONTROL
 Done within the production area and by production people and/or Quality Unit
 Should be recorded and done as per approved/written SOP
 Sampling done to verify:
 physical aspects (weight, volume, amount, etc)
 text on labels
 other performance requirements
 Sampling maybe conducted based on need :
 during processing activity
 during packaging (filling & packing) activities : random, sequential, or statistical
 Samples taken away from the packaging line should not be returned if containers were opened
 Record of in-process control should be part of the BMR.

RECONCILIATION
— Any deviation from the procedures should be avoided as much as possible. If deviations occur, they should be
approved in writing by a designated person, with the involvement of the quality control department.
— Checks on yields and reconciliation quantities should be carried out as necessary to ensure that there are no
discrepancies outside acceptable limits.
— These are some points to be considered in the -------
• reconciliation of the batch:
- quantity of starting materials
- output of finished products
• - machine efficiency
• —All activities of reconciliation should be conducted
• based on written standard operating procedures.

BATCH NUMBERING SYSTEM (1)
🖙 A product identification number/batch number should be assigned to:
✴ every finished product

✴ every bulk and semi finished product
which enables the history of the product to be traced.
🖙 A batch numbering system should be unique

✴ specific for the product
✴ non repetitive for the same product
🖙 Creation of batch number should be based on written guideline (SOP)

BATCH NUMBERING SYSTEM (2)
🖙 The batch number should be printed on:
✴ primary packaging
✴ secondary packaging (as necessary)
🖙 A batch number may give information on :
✴ date and year of production
✴ country, manufacturer or subcontractor
✴ sequence of production
🖙 Records of batch number should be kept and maintained
✴ for every finished product
✴ until at least 1 year after the expiry date
✴ for traceability factor

HANDLING OF REJECTED OUTPUT
Rejected product should be properly labeled and physically separated
Investigation of the root cause of rejection should be done by production and assisted by quality Unit
SOP in handlingrejected product should be established, written and approved
If rework can be done, written procedure should be prepared by production and approved by quality
Control
Stability of reworked products should be verified and if necessary additional testing
should be performed

REPROCESSING
 There should be a written policy which clearly states that
such action is allowed to be done.
 Reprocessing of rejected product should only be done in exceptional cases.
 It should only be allowed if the quality of the product is not negatively affected and the product quality
still complies with the specifications.
 It should consider additional testing of reprocessed product, e.g. stability testing of the batch.
 Complete records should be maintained for reprocessed product
 A reprocessed product should be given a new batch number.

RETAINED SAMPLES
Sample retention program should be carried out for reference and retesting for stability and in
case of product complaint.

PRODUCTION DOCUMENTS

PRODUCTION DOCUMENTS
Production documents of each pharmaceutical product should consist of:-
 Batch manufacturing record ( BMR )
 Record of Quality Control

BATCH MANUFACTURING RECORD
a. Batch Manufacturing Record should be prepared for each batch of product.
b. Each BMR should include the following :
 Name of product
 Batch formula
 Brief manufacturing process
 Batch number
 Date of the start and finish of processing and packaging
 Identity of individual major equipment and lines or location used
 Records of cleaning and sanitation of equipment used for processing as appropriate
 In-process control and laboratory results, such as pH and temperature test records
 Packaging line clearance inspection records
 Any sampling performed during various steps of processing
 Results of examinations on packed and labelled products

PACKAGING OPERATIONS
Before packaging operations are begun, steps should be
taken to ensure that the work area, packaging lines, printing
machines and other equipment are clean and free from any
products, materials or documents used previously and
which are not required for the current operation.

The line clearance should be performed according to an
appropriate procedure and checklist, and recorded.
The name and batch number of the product being handled
should be displayed at each packaging station or line.
Normally, filling and sealing should be followed as quickly as
possible by Labelling ; otherwise mix ups or mislabelling can occur.
Production records should be reviewed as part of the approval
process of batch release before transfer to the authorized person.

GMP QUALITY CONTROL
QUALITY CONTROL
PRINCIPLES

GENERAL PRINCIPLES
 Each holder of a manufacturing authorization should have a QC Department
 Independence from production and other departments is considered to be fundamental
 Under the authority of an appropriatelyqualified and experienced person with one or several control laboratoriesat his or
her disposal.
 If do not have any facility, it can be managed by appointed respective external laboratory institution(s).

BASIC REQUIREMENTS OF QUALITY
CONTROL

BASIC REQUIREMENTS
Quality Control department should have :
 resources:
 adequate facilities
 qualified personnel
 approved written procedures
 tasks :
 sampling, inspecting, testing,
 releasing or rejecting
 monitoring
 objects :
 Starting materials, intermediates, bulk, and finished products
 Returned products
 Environmental conditions Arvind Kumar Srivastava , Dy. Manager
RESPONSIBILITIES
• Examines, approves or rejects incoming materials, intermediates,
• bulk, the finished products, and returned products.
• Does the inspection during production (in-process control)
• Establishes, standardizes, and implements all QC procedures, and also establish the specification of each incoming
materials.
• Approves reprocessing instruction and rework instruction
• Involves in all decisions concerned with the product quality

OTHER RESPONSIBILITIES
 Evaluating, maintaining, storing, and monitoring all reference standards and retained
samples
 Maintaining correct specification of materials and finished products

 Stability testing of each finished product
 Participating in :
 complaint investigations
 environmental monitoring

LABORATORY DOCUMENTATION
Laboratory documentation includes
 Sampling procedures
 Calibration and Maintenance Equipment
 Stability Procedures, where applicable
 Environment Monitoring, where applicable
 Testing procedures and records (including worksheets and/or laboratory notebooks)
 Analytical reports and/or certificates

TASKS OF QUALITY CONTROL

RECEIPT
• There should be written procedure on the receiving, internal labeling, quarantine and storage of starting
materials, packaging materials and other materials as appropriate
• Upon receiving of the supplied goods, its identity, legibility of batch number, integrity of its primary packaging and
seal shall be verified prior to acceptance.
• Certificate of Analysis shall be provided by the supplier with the receiving of starting materials
• Quarantined goods shall be segregated from “Released”goods
• Rejected goods shall be stored in a define area with consideration of control access (e.g. Locked area)

SAMPLING
• The sample taking shall be done in accordance with written procedure that describe:
• The method of sampling
• The sampling tools used
• The amount of samples to be taken
• The type and condition of the sample container to be used
• (i.e. amber glass bottle)
• The identification of the container sampled
• Special precaution for hazardous materials
• The storage condition (if any)
• Instruction for cleaning and storage of sampling equipment
• Instruction for re-sealing the opened container.

TESTING & ANALYSIS
All tests shall be performed in accordance with the test methods as
stated in the specification
Test can be performed by in-house laboratory or external
laboratory

RETAINED SAMPLES (1)
• Retained sample should be representative of the batch of materials or products from which
they are taken.
• Retained sample shall be of a size sufficient to permit at least 2 full re-examinations
• Retain samples for each batch of finished products shall be retained for a defined period
• Finished product should be kept in their final packaging and stored under the
recommended condition (e.g.. Consumer used condition , at room temperature)

RETAINED SAMPLES (2)
• A retained sample log shall be maintained with the sample identification,
batch number and its storage location for ease of retrieval
• Prior to disposal of retain sample, visual inspection should be carried

out

OUT OF SPECIFICATION INVESTIGATION
(OOS)
• Written procedure should be made available.
• Typically, an investigation includes:
• A review of the calculations to ensure they are correct.
• A review of test procedures utilized.
• A review of equipment, columns, charts and previous analyses of
samples of the same product/material
• A review of reagent/ standardization carried out for the test (e.g.,pipettes).
• A complete investigation and evaluation of initial results prior to a retest.
• A review of product/material history
• Assigned person responsible for investigation
• Documented rational for retest and re-samplin.
ENVIRONMENT MONITORING
• Environment Monitoring to be implemented where appropriate.
• The objective is to demonstrate that manufacturing environment is functioning at an
adequate level of microbial control for the specific product/product group.

GMP SANITATION AND HYGIENE
OBJECTIVES
The aim of sanitation and hygiene measures is
to eliminate all potential sources of
contamination and cross-contamination from
all areas where the product quality is at risk.

SCOPE
 Sanitation and hygiene should be practiced to avoid contamination of personnel and avoid
contamination during manufacturing of products.
 It should cover all aspects of manufacturing:
 Personnel
 Premises
 Equipment and apparatus
 Production materials and containers
 Products for cleaning and sanitation
 All potential sources of contamination
CLEANING PRINCIPLES
— Cleaning operations shall be performed in a manner to prevent contamination of
materials and products.
— All cleaning compounds and sanitizers shall be properly labelled and stored in a locked
compartment, away from production and storage areas.
— Cleaning equipment and tools shall be supplied and be readily available for use. All
cleaning equipments shall be maintained and stored in such a way as not to contaminate
product or equipment.

BENEFITS
For personnel :
 To prevent contamination risk that effect personnel health
For product :
 To prevent contamination of the products
 To maintain the high standard of product quality
For company :
 To save on cost, avoid reworks and rejects
 To avoid consumer complaints
 To avoid potential product recall
For consumers :
 To get safe and good quality product
PERSONNEL HYGIENE

Personal hygiene is very important aspect of GMP. All personnel working in the
production area are expected to maintain a high degree of personal cleanliness.
All personnel, prior to and during employment, as appropriate, should undergo health
examinations.
Medical examination: Every employee must undergo medical examination including eye
examination especially for those who are responsible for visual inspection of drug
products.
All employees working under GMP must be free from tuberculosis, skin and other
communicable or contagious disease and must have medical examination at least once a
year and their records should be maintained properly. Employees should be trained in
practices which ensure personal hygiene. If there is any apparent illness or open lesions,
supervisors must be informed immediately and person should not be allowed to handle
starting material, packaging material, in-process materials or drug products as it may
cause the microbial contamination in drug product.

Nails should be clean and trimmed and use of nail polish is prohibited in the
production area as it may flake off and contaminate the product

Hands must be free of any lesions, wounds, cuts, boils, or any other sources
of infection.

Hands must be washed with soap before starting work, after break time, after lunch, after using washroom,
after blowing nose, after handling garbage or whenever your hands become contaminated. Wash hands
before putting a new pair of gloves and change gloves at every break, when torn or after touching garbage
and after touching your face and blowing nose. All used gloves must be disposed in the garbage cans
provided.

HEALTHY & GOOD HABITs
Employees shall be encouraged to practice good personal hygiene habits at all times.
Personnel should be healthy and capable to perform their assigned duties.
Regular medical examination must be conducted for all production personnel involved in
manufacturing processes.
 during recruitment process
 every regular period

GOOD PERSONNEL
HYGIENE
Personnel must practice good personal hygiene.
regular bathing every day
brushing of teeth
washing hands
 before entering the
production area
 after visiting the toilet
 after eating
 after smoking

HAND WASHING GUIDELINES
1. Wet your hand with
flowing water
4. Rinse your hand
2. Use soap around with flowing water
your hand and
fingers.
5. Dry your hand with tissue or

hand dryer at 320 – 600C.
3. If needed use brush

to clean your nails 6. Don’t touch anything. If
can not be avoided, repeat
step 1-5

PERSONNEL WITH
ILLNESS
Personnel should be instructed and
encouraged to report to their immediate
supervisor when they are ill or when they
see any conditions that may adversely
affect the product quality.

NO EATING, DRINKING & SMOKING
“No Eating”, “No Drinking”, “No Smoking”, and “No Chewing Gum” policy shall be strictly implemented
Food shall not be kept in production, warehouse or laboratory area.
No Eating,
No Drinking
No Smoking

SANITATION FACILITIES
Each plant shall be equipped with adequate sanitary facilities including, but not limited to:
a. Water supply
b. Plumbing
c. Toilet facilities
d. Hand washing facilities
e. Rubbish disposal
f. Changing facility or locker
which should be sufficient, adequate in size and design, and properly installed for easy cleaning and
sanitation processes.

Sanitation Facilities
WATER SUPPLY & PLUMBING
 Water is the main source of product contamination.
 The water supply shall be sufficient for the operations
intended and shall be derived from an adequate source.
 Plumbing shall be of adequate size and design and
adequately installed
and maintained to:
 carry sufficient quantities of water to required locations
 properly convey sewage and liquid disposable waste
 provide adequate floor drainage in all areas
 ensure that there is no back-flow from, or cross-connection between

piping systems Arvind Kumar Srivastava , Dy. Manager
SANITATION FACILITIES HAND
WASHING & TOILET
Adequate employee’s washing and well ventilated
toilet facilities should be provided and separated
from the production area.
 Must be kept clean at all times
 Well maintained
 With adequate supply of water
 Provided with soap, hand dryer or paper towel
 Used properly by all employees

SANITATION FACILITIES RUBBISH
DISPOSAL
Waste material should be placed in suitable container and regularly collected for disposal outside the production
areas.
Regular & timely collection of garbage
Garbage bins must be properly covered at all times No food wrapper to be thrown in garbage cans inside the
production area
Do not use product shipping cases as garbage bins

SANITATION FACILITIES CHANGING ROOM(S)
Suitable changing facilities or locker should be provided at appropriate location for

the storage of employees’ clothing and personal belongings
Personal belonging shall
be kept in lockers
or drawers.

GMP PRODUCT
COMPLAINT

COMPLAINT HANDLING PRINCIPLES
1. Complaints should be handled in accordance with a written procedure
2. Carefully reviewed and handled positively
3. Managed by an appointed responsible person
4. Must be given importance

5. complete investigation of the cause is essential
6. A major source of information and learning

7. Enable possible production defects to be remedied before they lead to a recall.
8. Necessary actions taken - even a recall decision
9. All complaints should be well documented

RESPONSIBLE PERSON
Within each company a person with adequate knowledge shall be assigned the task of
dealing with complaints.
This person must also have the authority to decide the measures and actions to be
taken.

INVESTIGATION
 The person in charge of complaints is responsible for initiating the investigation immediately. The person
responsible for Quality Control should normally be involved in the investigation.
 The investigation shall be documented in writing.
 If a product defect is discovered or suspected in a batch, consideration should be given to

determine whether other batches are also affected.
 The investigation should also cover:

distribution condition
condition under which the product is used

REMEDIAL ACTIONS
 The person in charge of complaints is responsible for the remedial action decided upon
completion of investigation.
 If it has been decided to make a recall , Product Recall Procedure shall be applied.

COMPLAINT & DEFECTS
CLASSIFICATION
• If complaint is justified, then there has been a failure of the quality system
• Once defect has been identified, company should be dealing

with it in an appropriate way, even recall.
• The definition of defects is useful :-
 Critical defects
 Major defects
 minor defects

CRITICAL DEFECTS
Those defects which can be life threatening and require company to take
immediate action by all reasonable means, whether in or out of business hours.
Examples :
 Product labeled with incorrect name or incorrect formula
 Counterfeit or tampered product

MAJOR DEFECT
A defect, which is a non conforming product, in view of the consumer, it may
not be hazardous.
Example:
 Microbiological contamination of products with

some risk for users
 sub standard products

MINOR DEFECT
A defect ,which has no important effect upon the use of the product and does not produce a
hazard.
Example :
Lacking in labeling , packaging.

DOCUMENTATION
Documentation of complaint investigation :
 Each individual complaint and relevant attached documents shall be

filed.
 A final report shall be prepared and documented.
 In the event of product recall (product safety) the authority should be

notified
GMP PRODUCT
RECALL
PROCESS

INTRODUCTION
OBJECTIVES
 To identify the key issues of product known or suspected to be defective.
 To put in place a system, procedures and resources to make the product recall.

DEFINITION (1)
• Product recall :
is a process taken by the responsible person who placed the product on the
market, to remove or withdraw a particular product from all links of
distribution.
• The removal or withdrawal may be due to critical quality defects discovered or
serious adverse reactions reported causing health risks to users during and
after distribution of the product

DEFINITION (2)
 Safety Alert :
Advice regarding a specific situation of a product, which is not conforming with the
safety specification. When there is a risk of significant hazard to consumers of a product
which has been distributed on the market ,the manufacturer should disseminate the
safety alert through mass communication media available including newspaper, radio and
television
 Withdrawal:
Removal of product from sale or use for reasons not connected with quality and safety
such as change of packaging etc. as a marketing strategy
 Recall for Product Correction:
the removal of product for rework.

REASONS FOR RECALL
Voluntary recall :
 Customer complaint
 Detection of quality and safety failure after release
 Result from the ongoing stability testing
 Result of an inspection
 Tampering
 Reportable adverse event
Mandatory recall :
 Directed by the national regulatory authorities

BASIC REQUIREMENTS
 the responsible person is independent from seller or marketing
 Must have an effective recall SOP in place.
 Distribution records should be readily available to responsible
person.
 Secured storage for goods awaiting disposition.
 If required, public warning/notices will be issued in order to alert
the customers.
 Progress recorded and final report issued
 Reconciliation between delivered and recovered quantities.
Documentation

Documentation
Good documentation is an
essential part of the quality
assurance system.

Documentation
•Documents should be approved, signed and dated by the appropriate responsible persons.
•No document should be changed without authorization and approval.
•Documents should have unambiguous / clear contents: the title, nature and purpose
should be clearly stated.
•They should be laid out in an orderly fashion and be easy to check.

Documentation
•Documents should be regularly reviewed and kept up to date.
•When a document has been revised, a system should exist to prevent inadvertent /
unintended use of the superseded version. Superseded documents should be retained for a
specific period of time.
•Documents should be designed, prepared, reviewed, and distributed for use per
established procedures. These should have characteristics of being attributable, legible,
contemporaneously recorded, original, and accurate (referred as ALCOA).

Documentation
The purpose of Good Documentation Practices is as below --------------------
•to define the specifications and procedures for all materials and methods of manufacture and control.
•to ensure that all personnel concerned with manufacture know what to do and when to do it
• to ensure that authorized persons have all the information necessary to decide whether or not to release a
batch of a medicine for sale
•to ensure the existence of documented evidence, traceability
• to provide records and an audit trail for investigation
•To ensure the availability of data for validation, review, and statistical analysis.

Documentation
The design and use of documents depend upon the manufacturer and the required documents are as below -------
•Labels
•Specifications and testing procedures
•Specifications for starting and packaging materials
•Specifications for intermediate and bulk products
•Specifications for finished products
•Master formulae
•Packaging instructions
•Batch processing records
•Batch packaging records
•Standard operating procedures andKumar
Arvind records.
Srivastava , Dy. Manager
Documentation
Different Types of GMP Documents as per USP :
•Laboratory Records
•Equipment Related Documentation
•Deviations and Investigations
•Batch Records
•Certificates of Analysis
•Standard Operating Procedures
•Protocols and Reports
•Analytical Procedures
•Training Documentation


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cGMP’s FOR

Arvind Kumar Srivastava , Dy. Manager

Arvind Kumar Srivastava , Dy. Manager

Arvind Kumar Srivastava , Dy. Manager

….. that part of Quality Assurance which Quality Assurance

ensures that products are consistently

an integral part of Quality Assurance

Arvind Kumar Srivastava , Dy. Manager

 cGMP as per Schedule M

 cGMP as per WHO

 cGMP as per MHRA

 cGMP as per TGA

 cGMP as per USFDA

 cGMP as per PICS

Arvind Kumar Srivastava , Dy. Manager

Arvind Kumar Srivastava , Dy. Manager

 Maintains Manufacturing Consistency.

 Prevent /control Contamination and Cross-Contamination

Prevents side effects

Arvind Kumar Srivastava , Dy. Manager

Arvind Kumar Srivastava , Dy. Manager

Arvind Kumar Srivastava , Dy. Manager

Arvind Kumar Srivastava , Dy. Manager

Arvind Kumar Srivastava , Dy. Manager

Arvind Kumar Srivastava , Dy. Manager

for washing , toilet , Maintenance workshops

Products, Products in Quarantine, and Released, Rejected, Returned or Recalled Products.

WEIGHING AREAS Sampling , Weighing / dispensing

PRODUCTION AREAS Processing, Equipment Washing, Storage of Cleaned Equipment

QUALITY CONTROL AREAS

Arvind Kumar Srivastava , Dy. Manager

Arvind Kumar Srivastava , Dy. Manager

Arvind Kumar Srivastava , Dy. Manager

 Solid concrete with epoxy is

suitable for processing areas as

it has a non- porous non skid

surface and retards bacterial

Arvind Kumar Srivastava , Dy. Manager

Arvind Kumar Srivastava , Dy. Manager

Arvind Kumar Srivastava , Dy. Manager

Storage of toxic substance Returned / recalled products Printed packaging materials

Segregation Should be Provided for the Storage of Rejected, Recalled, or

Arvind Kumar Srivastava , Dy. Manager

Arvind Kumar Srivastava , Dy. Manager

Quarantine status is ensured by

Arvind Kumar Srivastava , Dy. Manager

Reject area should be kept

under lock and key.

Arvind Kumar Srivastava , Dy. Manager

Arvind Kumar Srivastava , Dy. Manager

The weighing of starting materials should be carried out in a separate

• permit the orderly & logical

• avoid cross contamination and

 Covings where floor meets walls

 Recessed light fittings where

Arvind Kumar Srivastava , Dy. Manager

Arvind Kumar Srivastava , Dy. Manager

Premises for the packaging of

Proper storing of hoses

Arvind Kumar Srivastava , Dy. Manager

Store working shoes separately.

biological, microbiological or radioisotope test methods are employed should be

separated from each other.