GOOD MANUFACTURING

PRACTICES (GMP)
 GOOD MANUFACTURING PRACTICES (GMP)
• As per WHO, GMP is a part of Quality Assurance which ensures that products are
consistently produced & controlled to the quality standards appropriate to their
intended use & as required by Marketing Authorization or Product Specifications.
• GMP are aimed primarily at diminishing the risks inherent in any pharmaceutical
production e.g. cross contamination and mix-ups.
• GMP define a quality system that manufacturers use as they build quality into their
products because finished product testing is not a guarantee of quality.
• For controlling the quality some rules must be followed, provided by GMP.
• GMP works in conjunction with
➢ Quality Control, QC
➢ Quality Assurance, QA
WHY GMP ?

Potent weapon to fight disease,

Hence, potent weapon should have,
SISPQ

Safety
Safety purity
 OBJECTIVES
• To understand where the regulations are coming from?
• Who enforces them?
• Why do we need to comply?
Mandatory regulations
GLPs (Good Laboratory Practices)
• Pre-clinical, EPA
GCPs (Good Clinical Practices)
• Clinical studies
GMPs (Good Manufacturing Practices)
• Production and distribution of drugs and devices for human use
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1969,
CURRENT GOOD MANUFACTURING PRACTICES
(CGMP)
• cGMP refers to the Current Good Manufacturing Practice regulations
enforced by the US Food and Drug Administration (FDA).
• cGMP provide for systems that assure proper design, monitoring and control
of manufacturing processes and facilities.
• Adherence to the cGMP regulations assures the identity, strength, quality and
purity of drug products by requiring that manufacturers of medications
adequately control manufacturing operations.
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• This includes establishing strong quality management systems, obtaining

appropriate quality raw materials, establishing robust operating procedures,
detecting and investigating product quality deviations, and maintaining
reliable testing laboratories.
• This formal system of controls at a pharmaceutical company, if adequately put
into practice, helps to prevent instances of contamination, mix-ups, deviations,
failures, and errors. This assures that drug products meet their quality
standards.
IMPORTANCE OF CGMP

• A consumer usually cannot detect (through smell, touch, or sight) that a drug
product is safe or if it will work.
• While cGMPs require testing, testing alone is not adequate to ensure quality.
• In most instances testing is done on a small sample of a batch (for example, a
drug manufacturer may test 1000 tablets from a batch that contains 2 million
tablets), so that most of the batch can be used for patients rather than
destroyed by testing.
Classification of Modern Quality Systems
Modern Quality
Systems

Quality by Quality risk

design (QbD) management
(QRM)

Corrective &
preventive action Change control Six system model Quality unit
(CAPA)
QUALITY SYSTEMS IN PHARMACEUTICAL
INDUSTRY
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What is Quality by Design (QbD)?
 Quality by Design (QbD) is a systematic, risk-based approach to product
development that builds quality in from the start, rather than relying on later testing
to find flaws.
 It begins with predefined objectives and emphasizes product and process
understanding and process control.

(ICH Q8 (R1) June 2009)

What is QRM?
"Quality Risk Management is a systematic process for the assessment, control,
communication and review of risks to the quality of the medicinal product across
the product lifecycle."
( ICH Q9, on Quality Risk Management, doc. approved 2005)
 Change Control:
. Changes to any process must be documented, justified, and validated.
Six-System Inspection Model:
A model that can help pharmaceutical manufacturers comply with cGMP regulations.
• The six systems referred to in this inspection model are:
➢quality,
➢production,
➢facilities and equipment,
➢laboratory controls,
➢materials, and
➢packaging and labeling
PRINCIPLES OF GMP
• 1. Design and construct the facilities and equipment properly.
• 2. Follow written procedures and Instructions.
• 3. Document work.
• 4. Validate work.
• 5. Monitor facilities and equipment.
• 6. Write step by step operating procedures and work on instructions.
• 7. Design, develop and demonstrate job competence.
• 8. Protect against contamination.
• 9. Control components and product related processes.
• [Link] planned and periodic audits.
CURRENT GOOD MANUFACTURING PRACTICE
REGULATIONS
1. PERSONNEL
Principle. The establishment and maintenance of a satisfactory system of quality assurance and
the correct manufacture and control of pharmaceutical products rely upon people. For this
reason, there must be sufficient qualified personnel to carry out all the tasks for which the
manufacturer is responsible.
General
• The manufacturer should have an adequate number of personnel with the necessary
qualifications and practical experience to carry out tasks
• Aware of the principles of GMP
• Key personnel should have adequate education and practical experience
• Trained appropriate to their duties
• Individual responsibilities should be clearly defined
• Prohibition of unauthorized persons to production, storage and quality control
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2. SANITATION AND HYGIENE
• A high level of sanitation and hygiene should be practiced in every aspect of the manufacture of
drug products. There shall be written procedures assigning responsibility for sanitation and
describing in detail the cleaning schedules, methods, equipment, and materials to be used in
cleaning the buildings and facilities.
• The scope of sanitation and hygiene covers personnel, premises, equipment and apparatus,
production materials and containers, products for cleaning and disinfection, and anything that
could become a source of contamination to the product.
• Potential sources of contamination should be eliminated through an integrated comprehensive
program of sanitation and hygiene.
• All personnel, prior to and during employment, as appropriate, should undergo health
examinations.
• An air supply filtered through high-efficiency particulate air (HEPA) filters under positive pressure,
regardless of whether flow is laminar or nonlaminar; should be maimtained.
3. PREMISES
Principle.
Premises must be located, designed, constructed, adapted and maintained to suit the
operations to be carried out.
General
• The layout and design of premises must aim to minimize the risk of errors and permit
effective cleaning and maintenance in order to avoid cross contamination, build-up of
dust or dirt, and in general, any adverse effect on the quality of products.
• Where dust is generated (e.g. during sampling, weighing, mixing and processing
operations, or packaging of powder), measures should be taken to avoid cross-
contamination and facilitate cleaning.
• Each building’s structure, space, design, and placement of equipment must be such to
enable thorough cleaning, inspection, and safe and effective use for the designated
operations.
• There shall be separate or defined areas or such other control systems for the firm's
operations as are necessary to prevent contamination or mixups during the operations.
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• Premises should be carefully maintained, and it should be ensured that repair and
maintenance operations do not present any hazard to the quality of products.
• Premises should be cleaned and, where applicable, disinfected according to detailed
written procedures. Records should be maintained.
• Electrical supply, lighting, temperature, humidity and ventilation should be appropriate and
such that they do not adversely affect, directly or indirectly, either the pharmaceutical
products during their manufacture and storage, or the accurate functioning of equipment.
• Premises should be designed and equipped so as to afford maximum protection against
the entry of insects, birds or other animals. There should be a procedure for rodent and
pest control.
• Premises should be designed to ensure the logical flow of materials and personnel.
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[Link]
• The term refers to all the machines and equipment involved in product development,
quality testing and maintenance of various working conditions.
• Equipment layout and design must aim; to minimize the risk of errors and permit
effective cleaning.
• Measuring equipment must be calibrated while the broken must be removed and
changed.
• Production equipment should be thoroughly cleaned according to a fixed schedule.
• Laboratory equipment and instruments should be suited to the testing procedures
undertaken.
• Washing, cleaning and drying equipment should be chosen and used so as not to be
a source of contamination
 5. MATERIALS
Principle.
The main objective of a pharmaceutical plant is to produce finished products for patients’ use from a
combination of materials (starting and packaging). Materials include starting materials, packaging materials,
gases, solvents, process aids, reagents and labelling materials.
General
• No materials used for operations such as cleaning; lubrication of equipment and pest control should come
into direct contact with the product. Where possible, such materials should be of a suitable grade (e.g.
food grade) to minimize health risks.
• All incoming materials and finished products should be quarantined immediately after receipt or
processing, until they are released for use or distribution.
• All materials and products should be stored under the appropriate conditions established by the
manufacturer, and in an orderly fashion, to permit batch segregation and stock rotation by a first-expire,
first-out rule.
• Water used in the manufacture of pharmaceutical products should be suitable for its intended use.
6. DOCUMENTATION
• Principle.
• Good documentation is an essential part of the quality assurance system and, as such,
should exist for all aspects of GMP.
• Its aims are 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.
• General
• Documents should be designed, prepared, reviewed and distributed with care.
• 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 contents: the title, nature and purpose should be
clearly stated.
• Documents should be regularly reviewed and kept up to date.
STANDARD OPERATING PROCEDURES AND RECORDS
SOPs and associated records of actions taken or, where appropriate, conclusions
reached should be available for:
• (a) equipment assembly and validation;
• (b) analytical apparatus and calibration;
• (c) maintenance, cleaning and sanitization;
• (d) personnel matters including qualification, training, clothing and hygiene;
• (e) environmental monitoring;
• (f) pest control;
• (g) complaints;
• (h) recalls;
• (i) returns.
7. Qualification and Validation
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• Each pharmaceutical company should identify what qualification and validation work is
required to prove that the critical aspects of their operation are controlled. The key elements
of a qualification and validation program of a company should be clearly defined and
documented in a validation master plan and documentary evidence should be provided for
all qualification and validation activities carried out.

8. Complaints
• All complaints and other information concerning potentially defective products should be
carefully reviewed according to written procedures and the corrective action should be taken.

9. Product Recalls
• There should be a system to recall from the market, promptly and effectively, products known
or suspected to be defective.
. 0. Self-Inspection, Quality Audits and Suppliers’ Audits and
1
Approval
The purpose of self-inspection is to evaluate the manufacturer’s compliance with GMP in all aspects of
production and QC. The self-inspection program should be designed to detect any shortcomings in the
implementation of GMP and to recommend the necessary corrective actions. Self-inspections should be
performed routinely, and may be, in addition, performed on special occasions, e.g., in the case of
product recalls or repeated rejections, or when an inspection by the health authorities is announced.
The team responsible for self-inspection should consist of personnel who can evaluate the
implementation of GMP objectively. All recommendations for corrective action should be implemented.
The procedure for self-inspection should be documented, and there should be an effective follow-up
program.

[Link]
The manufacturer should provide training in accordance with a written program for all personnel
whose duties take them into manufacturing areas or into control laboratories (including the technical,
maintenance and cleaning personnel) and for other personnel.
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Thank you!