Follow
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: Maintenance of equipment, cleaning, calibration and validation.
=>> GMP Validation.
=>> Production and In-process controls.
=>> Production Materials: Proper management.
=>> Packaging and Labeling of Products.
=>> Laboratory Controls.
=>> Personnel: Qualification, 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 Regulations.
