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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:
- Guidance on good manufacturing practice and good distribution practice ...
The European Medicines Agency's (EMA) provides answers to...
- Guidance on good manufacturing practice and good distribution practice ...
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 ...
The Commission has published EU Guidelines on Good Distribution Practice (GDP) in 1994 (2). Revised guidelines were published in March 2013 (3) in order to take into account recent advances in practices for appropriate storage and distribution of medicinal products in the European Union, as well as new requirements introduced by Directive
This Guide is based on the EU Guidelines on Good Distribution Practice (GDP) of Medicinal Products for Human Use (2013/C 343/01). The EU Guidelines have been adapted by the Expert Circle on GDP for PIC/S purposes. However, the EU specific references have been deleted in this Guide.
principles and guidelines of good distribution practice (GDP). Manufacturers distributing their own products should also comply with GDP. According to Article 85b, persons brokering medicinal products shall be subject to certain provision applicable to wholesale distributors, as well as specific provisions for brokering.
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 ...
