GMP (Good Manufacturing Practice)
Good Manufacturing Practice is the set of quality rules that ensures medicines and their ingredients are consistently produced and controlled to their intended quality. It covers premises, equipment, personnel, documentation, validation and change control. For active ingredients, ICH Q7 sets the GMP expectations. Compliance is checked through regulatory inspections of the manufacturing site.
Related terms
API (Active Pharmaceutical Ingredient)
An Active Pharmaceutical Ingredient is the substance in a medicine that produces its therapeutic effect. APIs…
Drug Master File (DMF)
A Drug Master File is a confidential submission to a regulator, most often the US FDA, that describes how a s…
GLP (Good Laboratory Practice)
Good Laboratory Practice is a quality system governing how non-clinical safety studies are planned, performed…
Pharmacopoeia
An official book of quality standards for medicines and their ingredients, with legal status in the countries…
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