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Good distribution practice (GDP) describes the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines is maintained throughout the supply chain. Human Compliance and inspections Regulatory and procedural guidance. Compliance with GDP ensures that:
Guidelines lay down appropriate tools to assist wholesale distributors in conducting their activities and to prevent falsified medicines from entering the legal supply chain.
The European Medicines Agency's (EMA) provides answers to frequently asked questions on good manufacturing practice (GMP) and good distribution practice (GDP), as discussed and agreed by the GMP/GDP Inspectors Working Group. The guidance provided by the working group in the form of questions and answers (Q&As) provides additional interpretation ...
These guidelines provide stand-alone guidance on Good Distribution Practice (GDP) for importers and distributors of active substances for medicinal products for human use. They complement the rules on distribution set out in the guidelines of EudraLex Volume 4, Part II, and apply also to distributors of active substances manufactured by themselves.
Good Distribution Practice (GDP) Guidelines. The following Guideline Tree contains the most important Guidelines on Good Distribution Practices (GDP) Good Distribution Practices. GDP for Medicinal Products. Guidelines of 5 November 2013 on Good Distribution Practice of medicinal product ...
Article 80 (g) of Directive 2001/83/EC provides that distributors must comply with the principles of and guidelines for GDP. The wholesale distribution of medicinal products is an important activity in integrated supply chain management.
In 2003 the WHO published its guideline on Good Trade and Distribution Practice for Pharmaceutical Starting Materials (GTDP) , the scope of which covered both active pharmaceutical ingredients and excipients.
