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GMP


GMP

Good Manufacturing Practices- GMP
WHO defines Good Manufacturing Practices (GMP) as “that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization.”

GMP covers all aspects of the manufacturing process: defined manufacturing process; validated critical manufacturing steps; suitable premises, storage, transport; qualified and trained production and quality control personnel; adequate laboratory facilities; approved written procedures and instructions; records to show all steps of defined procedures have been taken; full traceability of a product through batch records and distribution records; and systems for recall and investigation of complaints.

The guiding principle of GMP is that quality is built in to a product, and not just tested in to a product. Therefore, the assurance is that the product not only meets the final specifications, but that it has been made by the same procedures under the same conditions each and every time it is made. There are many ways this is controlled - validation is that part of GMP that ensures that facility systems, equipment, processes, and tests procedures are in control and therefore consistently produce quality product.

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