Good Manufacturing Practice Standard

Good Manufacturing Practice Standard

Good Manufacturing Practice (GMP) is a vital component of Quality Assurance to help ensure that therapeutic products and Chinese Proprietary Medicines (CPM) are consistently produced with the quality standards appropriate for their intended use. All manufacturers, including assemblers of therapeutic products and CPM intended for the Singapore market, are required to conform to the GMP standard.

As a member of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S), we adopt the PIC/S Guide to GMP for Medicinal Products (Part I) and its relevant annexes as our current GMP standards. Our GMP auditors will conduct audits on local manufacturers of therapeutic product and CPM for compliance with these GMP standards.

Common non-conformities  raised during GMP audits conducted in year 2019 - Classification of GMP Non-Conformities513 KB

Common non-conformities  raised during GMP audits conducted in year 2020 - Trending of GMP Deficiencies in 20201096 KB

Good Distribution Practice Standard

Good Distribution Practice Standard

Good Distribution Practice (GDP) is a vital component of Quality Assurance. It requires the company to establish a quality system which ensures that products are consistently stored and handled under appropriate conditions as required by the marketing authorisation or product specification.

Compliance to our Guidance Notes on Good Distribution Practice263 KB is mandatory for all local importers and wholesalers of Therapeutic Products and Chinese Proprietary Medicines intended for the Singapore market. Our GDP auditors will conduct audits on companies in accordance with these GDP standards prior to the issuance of local dealer’s licences.

Note: Our Guidance Notes on Good Distribution Practice is revised on 01 March 2021 to primarily include additional GDP requirements for Cell, Tissue and Gene Therapy Products (CTGTP). Please refer to the Guidance Notes on Good Distribution Practice (with Tracked Changes) 234 KB on the changes made on the latest version. Underline denotes addition while strike-through denotes deletion.

Common non-conformities raised during GDP audits conducted in year 2019
- Trending of GDP Non-conformities in 2019803 KB

Common non-conformities raised during GDP audits conducted in year 2020
- Trending of GDP Non-Conformities in 2020800 KB