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GMP is required by the pharmaceuticals industry, biotech companies, bulk drug API manufacturers, formulators and manufacturers of food processors, medical devices, cosmetics and other life-science industries.
More than 100 countries have incorporated GMP into their drug laws, and many more have adopted their own GMP requirements. However, WHO-GMP remains the basis for the WHO certification scheme and prequalification of vaccines.
In general, pharmaceutical firms and biotechnology companies follow GMPs to ensure that their products are manufactured to meet specific requirements such as identity, strength, quality, purity, efficacy and safety. Compliance is regulated by the Food and Drug Administration (FDA).
The topics covered in GMP and the following regulations in the following areas of the pharma industry.
=>> Area or location: buildings and facilities.
=>> Equipment: Equipment maintenance, cleaning, calibration and validation.
=>> GMP validation.
=>> Production and in-process control.
=>> Production Materials: Proper Management.
=>> Packaging and labeling of products.
=>> Laboratory controls.
=>> Personnel: Qualifications, Safety and Responsibilities.
=>> Complaints and recalls.
=>> Change control.
=>> Computer Systems and Information Technology.
=>> Quality Assurance and Quality Control.
=>> Documentation and record keeping of GMP procedures.
=>> Drug product regulation.
Poor quality medicines are not only harmful to health, but also a waste of money for both the government and the individual consumer, it can also lead to drug shortages. GMP controls all such quality issues of medical products and hence GMP is very important nowadays. Most countries accept the import and sale of drugs manufactured under internationally recognized GMP standards.
