Good Distribution Practice Certificate

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Regulatory Guidelines and Standards

Good Distribution Practice (GDP) certification is a voluntary scheme for interested company to seek official certification from HSA. A GDP certificate is a certificate relating to the storage and distribution of medicinal products or active pharmaceutical ingredients attesting to its conformity with the HSA's GDP Standard. A GDP Certificate is issued when the company's quality system has been audited and found to comply with HSA's GDP Standard.


Good Distribution Practices Standard

Good Distribution Practice is a quality system which ensures that medicinal products are stored and handled consistently under appropriate conditions as required by the marketing authorization or product specification so that the the quality of the products will be maintained during storage and distribution.

Importers and Wholesale Dealers of Medicinal Products are required to implement GDP. The Regulatory Inspectors of HSA will audits the company in accordance with the 
 HSA Guidance Notes On Good Distribution Practice. The scope of the audit will cover the following area where applicable:

  • Personnel
  • Premises And Facilities
  • Stock Handling And Stock Control
  • Disposal Of Products
  • Documentation
  • Product Complaints
  • Product Recall
  • Returned Materials
  • Counterfeit Products
  • Self-Inspection
  • Contract Activities
  • Handling Of Active Pharmaceutical Ingredient or Intermediates


Last updated on 22 Aug 2007 18:21:13