Regulatory
GMP (good manufacturing practice)
Definition
Rules for making medicines, APIs, food and cosmetics so that every batch is consistently produced and controlled to its quality standard.
GMP covers people, premises, equipment, documentation, production, quality control, complaints and recalls. For active pharmaceutical ingredients the main international guide is ICH Q7. In India, GMP for drugs is set by Schedule M of the drug rules made under the Drugs and Cosmetics Act, 1940, which was revised to align more closely with international practice.
A product can meet a pharmacopoeia monograph and still not be made under GMP. For pharma use, ask for the GMP certificate or inspection outcome that covers the specific site and product.
Related terms
- WHO-GMPGMP based on World Health Organization guidelines, often certified by national regulators for exports under the WHO certification scheme.
- DMF (Drug Master File)A confidential file submitted to the US FDA with detailed information on how an API, excipient or packaging is made and controlled.
- CEP (certificate of suitability)A certificate from the EDQM confirming that an API's quality is suitably controlled by the European Pharmacopoeia monograph.
- Pharmacopoeia monographThe official standard for a medicine or ingredient in a pharmacopoeia, listing its tests and acceptance limits.