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This application is a service of the Singapore Government.

Health Sciences Authority

Good Manufacturing Practice Certificate

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

Regulatory Guidelines and Standards

The Good Manufacturing Practice (GMP) certificate issued by HSA is a certificate relating to the manufacture of a therapeutic product, medicinal product, an active pharmaceutical ingredient or a cosmetic product attesting to its conformity with the relevant GMP Standard as appropriate.

A GMP certificate is granted when the manufacturing facility has been audited and found to demonstrate satisfactory compliance with the required GMP standard. The name and address of the manufacturing site and the scope of the certification will be defined on the GMP certificate. The scope of certification would normally be determined by the scope of the actual audit that was performed at the manufacturing facility and the types of dosage forms/range of products being manufactured. A GMP certificate would normally be valid for 3 years from the date of assessment. The certificate would be issued in the name of the local firm/company registered with the Accounting and Corporate Regulatory Authority, Singapore. The person making the application should be authorized by the company to do so as the person responsible (e.g. Managing Director, QA/QC Manager, Production Manager).

Pharmaceutical Inspection Convention/Co-operation Scheme (PIC/S) Guide to Good Manufacturing Practice (GMP) for Medicinal Products/Active Pharmaceutical Ingredient

For more information on the Pharmaceutical Inspection Convention/Co-operation Scheme (PIC/S) Guide to Good Manufacturing Practice (GMP) for Medicinal Products Part I and Part II (Active Pharmaceutical Ingredient), please click here.

The PIC/S Guide to GMP for Medicinal Products Part I can be downloaded from here.

The PIC/S Guide to GMP for Medicinal Products Part II can be downloaded from here.

Health Sciences Authority GMP Guidelines for Manufacturers of Cosmetic Products

For more information on the HSA GMP Guidelines for Manufacturers of Cosmetic Products, please click here.

The HSA GMP Guidelines for Manufacturers of Cosmetic Products can be downloaded from here.

New Information Related to Implementation of the Health Products (Therapeutic Products) Regulations 2016 (effective from 1 November 2016)

There will not be any change to the regulatory requirements in the application and issuance of the GMP Certificate.