Anda di halaman 1dari 8


The rst WHO draft text on good manufacturing practices (GMP) was prepared in 1967 by a
group of consultants at the request of the Twentieth World Health Assembly (resolution
WHA20.34). It was subsequently submitted to the Twenty- rst World Health Assembly under
the title Draft requirements for good manufacturing practice in the manufacture and quality
control of drugs and pharmaceutical specialities and was accepted.
What is cGMP?
Good Manufacturing Practice (GMP) is a term that is recognized worldwide for the control and
management of manufacturing and quality control testing of foods, pharmaceutical products and
medical devices.

These requirements concern methods, equipment or testing, which are used for the production,
processing, packaging and / or storage of drugs. This ensures that medicine products fulfil the
necessary quality criteria. At the same time the GMP regulations have an increasing influence
on suppliers of the pharmaceutical industry such as suppliers of APIs and excipients, packaging
materials, manufacturing facilities and testing equipment. The compliance of GMP-regulations is
constantly examined by inspectors of health care system authorities.
GMP is referred to as "cGMP" .The "c" stands for "current," reminding manufacturers that they
must employ technologies and systems which are up-to-date in order to comply with the
regulation.The current Good Manufacturing Practices formalize, through documented systems
and procedures, the quality requirements and attributes of all systems, operations, equipment,
and personnel. These procedures are often referred to as Standard Operating Procedures or
SOPs. The term manufacture is very inclusive and refers not only to the actual production of a
substance but also to all aspects of the manufacturing process including:

_ Organizational and Personnel Requirements
_ Facilities/Equipment/Systems Qualification
_ Receipt and Approval of Raw Materials
_ Production and Processing Controls
_ Packaging and Labeling Control
_ Quality Control of Materials and Systems
_ Systems and Process Validation
_ Laboratory Controls and Release of Finished
_ Product Stability Testing
_ Storage and Distribution

Quality control is the part of GMP that is concerned with sampling, specifications,
testing, documentation, and release procedures. Quality control ensures that the
necessary and relevant tests are carried out and that raw materials, packaging
materials, and products are released for use or sale, only if their quality is satisfactory.
Quality control is not confined to laboratory operations but must be incorporated into all
activities and decisions concerning the quality of the product.
The basic requirements of quality control are as follows:
Adequate facilities,
trained personnel,
approved procedures are available for sampling,
inspecting and testing of raw materials,
packaging materials,
intermediate bulk and finished products,
Why are cGMPs so important?
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 100 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. Therefore, it is important that drugs are manufactured under conditions and
practices required by the cGMP regulations to assure that quality is built into the design
and manufacturing process at every step. Facilities that are in good condition,
equipment that is properly maintained and calibrated, employees who are qualified and
fully trained, and processes that are reliable and reproducible, are a few examples of
how cGMP requirements help to assure the safety and efficacy of drug products.

How does FDA determine if a company is complying with cGMP regulations?
FDA inspects pharmaceutical manufacturing facilities worldwide using scientifically and cGMP-
trained individuals whose job it is to evaluate whether the company is following the cGMP
regulations. FDA also relies upon reports of potentially defective drug products from the public
and the industry. FDA will often use these reports to identify sites for which an inspection or
investigation is needed. Most companies that are inspected are found to be fully compliant with
the cGMP regulations.

What can FDA do to protect the public when there are cGMP violations?
If the failure to meet cGMPs results in the distribution of a defective drug, the company may
subsequently recall that product. This protects the public by removing these drugs from the
market. While FDA cannot force a company to recall a drug, companies will usually recall
voluntarily or at FDAs request. If a company refuses to recall a drug, FDA can warn the public
and could seize the drugs that are on the market.

Good manufacturing practices examples

Employee Training. Proper and adequate employee training is absolutely essential
for GMP implementation. Without effective training, safe production of foods is

Environmental Monitoring. Development of a comprehensive and effective food
facility environmental monitoring program for potential foodborne pathogens plays
an important role in the production of refrigerated and frozen ready-to-eat foods

Sanitation Practices. Sanitation is another essential component of any food safety
program, needed to help ensure that the food production environment and
equipment are free from pathogens and other unwanted microorganisms that could
potentially contaminate the product.

Allergen Management. Some individuals are highly sensitive to certain foods or
ingredients in foods and can develop serious allergic reactions after consuming
products containing these allergens. Milk and egg protein, shellfish and peanuts
are a few examples. Therefore, companies should maintain allergen management
programs to prevent unintentional inclusion of these allergens in products.

Temperature Monitoring. Temperature monitoring is critical for controlling the
growth, multiplication and, in some cases, toxin production of microorganisms in
some products, under certain conditions. Companies should determine the
relevance of temperature control for their specific products and validate specific
temperatures used in manufacturing, storage and distribution of food by
referencing applicable regulatory and/or nationally recognized documents or valid
scientific research.

Good manufacturing pratices for drugs
GMP are the part of quality assurance that ensures that drugs are consistently produced and
controlled in such a way to meet the quality standards appropriate to their intended use, as
required by the marketing authorization.
GMP basic requirements are as follows:
1. Manufacturing processes are clearly defined and controlled to ensure consistency and
compliance with approved specifications;
2. Critical steps of manufacturing processes and significant changes to the process are
3. All necessary key elements for GMP are provided, including the following:
o qualified and trained personnel,
o adequate premises and space,
o suitable equipment and services,
o correct materials, containers and labels,
o approved procedures and instructions,
o suitable storage and transport.
4. Instructions and procedures are written in clear and unambiguous language;
5. Operators are trained to carry out and document procedures;
6. Records are made during manufacture that demonstrate that all the steps required by
the defined procedures and instructions were in fact taken and that the quantity and
quality of the drug was as expected. Deviations are investigated and documented;
7. Records of fabrication, packaging, labelling, testing, distribution, importation, and
wholesaling that enable the complete history of a lot to be traced are retained in a
comprehensible and accessible form;
8. Control of storage, handling, and transportation of the drugs minimizes any risk to their
9. A system is available for recalling of drugs from sale;
10. Complaints about drugs are examined, the causes of quality defects are investigated,
and appropriate measures are taken with respect to the defective drugs and to prevent

1. Good Manufacturing Practices for pharmaceutical products. In: WHO Expert Committee
on Specifications for Pharmaceutical Preparations. Thirty-second report. Geneva, World
Health Organization, 1992, Annex 1 (WHO Technical Report Series, No. 823).

2. Validation of analytical procedures used in the examination of pharmaceutical materials.
In: WHO Expert Committee on Specifications for Pharmaceutical Preparations.
Thirty-second report. Geneva, World Health Organization, 1992, Annex 5 (WHO Technical
Report Series, No. 823).

3. Good manufacturing practice for medicinal products in the European Community. Brussels,
Commission of the European Communities, 1992.

4. Pharmaceutical Inspection Convention, Pharmaceutical Inspection Co-operation
Scheme (PIC/S). In: Guide to good manufacturing practice for medicinal plants, Geneva,
PIC/S Secretariat, 2000.

5. Quality assurance of pharmaceuticals. A compendium of guidelines and related materials.
Volume 2. Good manufacturing practices and inspection. Geneva, World Health Organization,

6.Codex Alimentarius Commission. CAC/RCP 066 2008: Hygienic Practice for Infant Formulae;
Environmental Testing and Monitoring Section.
7. Institute of Food Technologists. 2001. Definition of Potentially Hazardous Foods A report of
the Institute of Food Technologists for the Food and Drug Administration of the US Department
of Health & Human Services. December 31, 2001. IFT/FDA Contract No. 223-2333. Task Order