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CGMP Guidelines

The document provides an overview of current good manufacturing practices (cGMP) for pharmaceutical manufacturers. It discusses that cGMP are regulations for ensuring consistent production of safe drugs through defined manufacturing processes and quality control. The objectives of cGMP are to assure drug quality and safety for patients. It outlines the key requirements for cGMP compliance, including facilities, equipment, personnel, materials control, manufacturing operations, packaging, quality control, and record keeping.

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Ryan 1112
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180 views

CGMP Guidelines

The document provides an overview of current good manufacturing practices (cGMP) for pharmaceutical manufacturers. It discusses that cGMP are regulations for ensuring consistent production of safe drugs through defined manufacturing processes and quality control. The objectives of cGMP are to assure drug quality and safety for patients. It outlines the key requirements for cGMP compliance, including facilities, equipment, personnel, materials control, manufacturing operations, packaging, quality control, and record keeping.

Uploaded by

Ryan 1112
Copyright
© © All Rights Reserved
Available Formats
Download as PDF, TXT or read online on Scribd
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JSS Academy of Higher Education & Research

(Deemed to be University)
Accredited ‘A+’ Grade by NAAC
Sri Shivarathreeshwara Nagara, Mysuru – 570 015
Karnataka, INDIA

M. Pharm Digital Education Program


FACULTY OF PHARMACY
M. Pharm (Quality Assurance)

MQA 103T QUALITY CONTROL & QUALITY ASSURANCE


UNIT- 1
INTRODUCTION

SUB TOPIC (2/12):


Current Good Manufacturing Practice

Dr. N. KRISHNA VENI, JSSCPO


GOOD MANUFACTURING PRACTICES
(ORANGE GUIDE)
• Good manufacturing practices are defined as “A set of current, scientifically sound methods, practices
or principles that are implemented and documented during product development and production to
ensure consistent manufacture of safe, pure and potent products”.
• cGMP became official in 1963.
• Draft was prepared in 1975 and was implemented in June 1988.
• Designed to ensure that the entire process, from purchase of approved material through detailed,
defined production processes, using approved facilities and trained personnel operating in well
designed buildings through QC department to final distribution outlets.
• This results in achievement of consistent and uniformly good quality products. It is not required to
follow these rules and regulations however they may be necessary to insure a greater issue of
consumer safety and confidence.
• cGMP is a set of guidelines that are required by the US FDA for pharmaceutical manufacturers to
make use of and develop their own part procedures.
• To help ensure that quality includes entire manufacturing procedures and are maintained throughout
the product life.
• This starts with raw materials received and through the product creation and testing and does not
even end after the product is sold and consumed.
• Follow of cGMP is not compulsory but it is necessary to insure a greater issue of consumer safety and
confidence.
• Why current – because the requirements are always changing, as they should, to match the current
science and the changing nature of products and manufacturing.
• cGMP – also defined as “practices which are used to assure that a product or any of its component
parts, meets the requirements as to safety, has the identity and strength and meets the quality and
purity characters which it is intended to possess”.
• It is a comprehensive system, designed, documented, implemented and controlled and furnished

with personnel equipment and other resources as to provide assurance that products will be

consistently of a quality appropriate to their international standards.

• Thus the attainment of this quality object requires involvement and commitment of all concerned at

all stages.

• GMP is not a collection of product manufacturing processes and methods of analysis of raw materials

and finished products but a manual of the quality assurance procedure of the company. The

requirement is a set of documents which describe clearly the systems of control of materials,

processes and products and the procedures in the various departments which together constitute

these systems.
• GMP covers all the interacting activities and techniques related to handling of materials, manufacturing and QC.
A compilation of this nature serves both the company and the drugs control administration. For the former, it
becomes a statement of commitment that the things will be done the way management has decided in order to
provide assurance to itself and the public who by the products. For authorities the manuals provides authentic
and visible evidence of the systems operation in the company and obviates the need to obtain verbal information
on them.
• Quality is a commitment and cannot be achieved easily. Drug products must be formulated and manufactured
with care that standards and specifications are essential and drug marketing and specifications are regulated.
GMP requirements includes QA and QC.
• Quality is built in the product through checks in the process of production. It is a comprehensive system,
designed, documented, implemented and controlled and furnished with personnel, equipment and other
resources as to provide assurance that products will be consistently of a quality appropriate to their intended
use.
• The attainment of this quality objective required involvement and commitment of all concerned at all stages
OBJECTIVES
• Initially to assure quality of a product and finally the safety, well being and protection of patient.
• To perform every operation with the objectives of maintaining the identity and integrity and products
of effective production.
• To establish systems of control at all levels of manufacturing, right from the receipt of raw materials
by continous working, using correct equipment to dispatch finished goods from factory.
• cGMP is just a guideline, system and quality theme for compliance.
• It is just a way to built quality in a product.
• Improves productivity and minimizes rejection and mistakes.
REQUIREMENTS OF cGMP
All the requirements and practices and precautions that are necessary for building quality in a product
could be termed as GMP
• location and premises
• equipment and machinery
• personnel
• general house keeping and sanitation
• Raw materials control
• Control of manufacturing operations including labeling and packaging
• Quality control
• Containers
• Distribution and recall
• Self inspection
• Concept of zero defect
In short outline of GMP
Building for manufacturing, testing and storage operations are of adequate design, size and
construction to
• Provide for proper receipt and storage of raw materials
• Provide ease in maintaining cleanliness and for avoiding contamination
• Provide proper storage for in process and final products
• Provide adequate lighting and ventilation
Equipment is
• Properly located
• Adequate for the required operation
• Constructed to facilitate cleaning
• Properly maintained
• Raw materials re controlled by

• Establishment of suitable specifications

• Development of adequate test procedures

• Specific identification methods and labeling

• Proper storage conditions

• Adequate sampling

• Appropriate testing

• Compliance and specifications

• Providing for QC release

• Maintaining records and samples


Manufacturing operations are controlled by
• Use of suitable batch numbering system
• Preparation and use of formula or batch records
• Checking the ingredients, identity and quality
• Adherence to manufacturing instructions
• Maintaining identity during processing
• Checking quality during processing
• Checking actual yields against theoretical yields
• Adequate sampling and testing
• Compliance with specifications
• Requiring QC approval at critical stages/steps
• Maintaining appropriate records and samples
Packaging and finished products are controlled by

• Establishment of specification for packaging and packaging operations

• A formal procedure providing for the inspection and issuance of packaging materials including labels and
labeling

• Providing for the proper control of all printed packaging components

• Use of suitable batch, lot or control numbers and expiration date when necessary

• Maintaining identity of the product throughout packaging operation

• Checking actual yields against theoretical yields

• Sampling and checking for compliance with specifications

• Providing for release by QC

• Maintaining appropriate records and samples


Finished stock quality is maintained by
• Providing proper storage and shipping conditions and methods
• Investigation of complaints concerning quality of products
• Providing for disposition of returned goods
To satisfy FDA
• SOP’s should be written and followed by every department
• Protocols should be prepared (written procedures on doing each validation)
• Validation should be done(testing and statistical analysis verifying compliance)-for the following parameters
• Analytical methods – every test method used for product ingredients
• Process controls – Every product needs the entire process validated
• Cleaning procedures – Every piece of process equipments used
• Air sampling – Process areas tested
• Written procedures (detailed methods and specifications, followed and reviewed)
• Manufacturing (requiring each step to be verified by another person)
• Analytical
• Raw materials(Incoming ingredients)
• Finished goods (Outgoing products)
• Complete stability programs should be done for products (monitored and evaluated)
• Annual products review (lab testing results statistically studied and process procedures evaluated by batch/lot number)
• Calibrations (written procedures usually part of SOPs)
• Process equipment – all that is used for manufacturing products
• Analytical instruments – All that is used for testing procedures
• Analytical testing and statistical evaluation of raw materials and finished products
• Raw materials as product components
• Finished and in process products
• Stability sample program for products
• cGMP training program (Established, documented, and maintained for all personnel)
• designated controlled areas and written procedures for storage of received goods, quarantined, finished
products and rejected goods should be maintained
• plant design to include
• HEPA filtration of all air into production areas
• Positive air pressure in production areas
• Equipment use designed to minimize and exclude cross contamination between products
• Paper trail should be in place starting from incoming materials through stability testing after shipment
• Thoroughly documented, monitored, tested and evaluated by review
• Production water system
• Stability room
• Other production or lab equipment requiring special monitoring
• Complaints or adverse reaction programs in place. Written, evaluated and acted upon.
FDA INSPECTOR LOOKS FOR
• Human behavior
• Infestation
• Condition of equipment and utensils
• Condition of raw materials
• Toilets and wash room facilities
• Plant construction
• Waste disposal
• Condition of storage and handling of products
OTHER MANUFACTURING ASPECTS
• Building facilities
• Equipments
• Personnel
• Components and other materials used
• Master production and control records for each drug product and each batch should be maintained
• Reasonable precautions should be taken in Production and production control procedures
• Product containers and operations should be tested
• Packaging and labeling operations should be controlled
• Scientifically sound and appropriate standards and specifications and test procedures should be used
• Distribution records must be maintained
• Stability of finished products must be assured
• Suitable expiration dates of drug products must be instituted
• Complaints file should be maintained
• SOP’s should be prepared
• Protocols and validation are important for analytical methods, process controls and air sampling and
cleaning procedures
• Calibrations should be done for all equipments
• Analytical testing and evaluation is important
• cGMP training program is important
Thus the guidance describes “a complete quality system model which if implemented will allow
manufacturers to operate robust, modern quality systems that are fully complaint with cGMP
regulations”.
This is applicable to manufacturers of finished pharmaceuticals
Seven key concepts of cGMP
• quality – the quality of a pharmaceutical product is defined by its identity, strength, purity and
other properties that ensure its safety and effectiveness. Achieving quality means achieving the
defined properties of the product

• quality by design and product development: Designing and developing manufacturing


processes during product development that consistently ensure predefined quality at the end of
the manufacturing process is “Quality by design”. A quality system gives a sound framework for
the transfer of process knowledge from development to commercial manufacture and post
development changes and optimization

• Risk management and risk assessment: Risk assessment can guide the setting of specifications
and process parameters. Risk assessment is also used in determining the need for discrepancy
investigations and corrective actions”
• Corrective and preventive action: this well known cGMP concept focuses on investigating and
correcting discrepancies and trying to prevent recurrence. Quality system models discuss CAPA as
three concepts
• Remedial corrections
• Root cause analysis with corrective action to prevent recurrence
• Preventive action to prevent initial occurance
• Change control: this fundamental cGMP regulation manages change to prevent unintended
consequences and implementation of change control is an assigned responsibility of the quality
control unit. In the guidance “Change is presented in terms of creating a regulatory environment that
encourages change towards continous improvement”. The manufacturer is “Empowered to make
changes based on the variability of materials used in manufacturing and optimization of the process
from learning over times”
• Quality unit: Although the cGMP regulations are defined only a “Quality control unit”, industry
practice has been to divide the responsibilities between quality control(QC) and Quality
Assurance(QA) functions. QC usually is responsible for testing in process and finished products to
ensure compliance with specifications and limits. QA generally reviews and approves all procedures
related to production and reviews associated records. QA also audits and performs trend analyses.
• Six system inspection model: the current agency approach to conducting inspections is system
based and consistent with the quality systems model presented in the guidance. The six systems
are
• quality system
• production system
• facilities and equipments system
• lab controls system
• materials system
• packaging and labeling system
• This integrates the five manufacturing systems rather than treating them in discrete entities. The
systems based inspection program is intended to be able to assess whether each of the systems is in a
state of control.

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