Singapore legislation
Regulation 2
of Medicines (Good Manufacturing Practice Certificate) Regulations
Regulation 2
Definitions
In these Regulations, unless the context otherwise requires —“active pharmaceutical ingredient” means any raw material which is used as an active ingredient in the manufacture of a medicinal product;“Good Manufacturing Practice Certificate” or “GMP Certificate” means a certificate relating to the manufacture of any medicinal product or active pharmaceutical ingredient attesting to its conformity with a Good Manufacturing Practice Standard;“Good Manufacturing Practice Standard” means the Pharmaceutical Inspection Convention/Pharmaceutical Inspection Co-Operation Scheme Guide to Good Manufacturing Practice for medicinal products or active pharmaceutical ingredients (as the case may be) or such other good manufacturing practice standard approved by the licensing authority.
Definition
“active pharmaceutical ingredient” means any raw material which is used as an active ingredient in the manufacture of a medicinal product;
Definition
“Good Manufacturing Practice Certificate” or “GMP Certificate” means a certificate relating to the manufacture of any medicinal product or active pharmaceutical ingredient attesting to its conformity with a Good Manufacturing Practice Standard;
Definition
“Good Manufacturing Practice Standard” means the Pharmaceutical Inspection Convention/Pharmaceutical Inspection Co-Operation Scheme Guide to Good Manufacturing Practice for medicinal products or active pharmaceutical ingredients (as the case may be) or such other good manufacturing practice standard approved by the licensing authority.