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This application is a service of the Singapore Government.

Health Sciences Authority

Guidance Documents

Good Manufacturing Practice Certificate for Therapeutic Product/Medicinal Product/Active Pharmaceutical Ingredient/Cosmetic Product

Applicant for a GMP Certificate should provide a Site Master File as an attachment in application and submit via online services (PRISM).

For information on the preparation of a site master file, please refer to Guidance Notes for Pharmaceutical Manufacturers on Preparation of a Site Master File.

For cosmetic products manufacturers, please refer to Guidance Notes on Preparation of a Site Master File for Manufacturer of Cosmetic Products.

Applicant for a GMP Certificate of Therapeutic Products / Medicinal Products / Active Pharmaceutical Ingredient / Cosmetic Products should familiarize themselves with the relevant guidance notes.