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.
Trending of common deficiencies raised for GDP inspections conducted