Licensing and Certification of Importers and Wholesalers

  5. Good Distribution Practice Standards

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 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, 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) 234 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

Year
2021 Trending of GDP Deficiencies in 2021283 KB
2022  Trending of GDP Deficiencies in 2022294 KB
2023  Trending of GDP Deficiencies in 2023177 KB
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