5. Good Distribution Practice Standards
Establish a quality system that ensures your products are properly handled, stored and distributed to assure quality and integrity throughout the supply chain.
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 Practice [PDF, 280 KB] is mandatory for all local importers and wholesalers of Therapeutic Products, Chinese Proprietary Medicines, Cell, Tissue and Gene Therapy Products and Active Ingredients 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 15 December 2023, primarily to clarify the GDP requirements for the handling of Active Ingredients, under the new Health Products (Active Ingredients) Regulations 2023. Please refer to the Guidance Notes on Good Distribution Practice (with Tracked Changes) [PDF, 261 KB] which reflect the changes made in the latest revision. Underline denotes addition while strike-through denotes deletion.
Trending of common deficiencies raised for GDP inspections conducted
List of common deficiencies raised
