Guidelines of 19 March 2015 on principles of Good Distribution Practice of active substances for medicinal products for human useThe long-awaited guideline GDP for APIs has been published as final versions in the official journal of the European Union.
The guideline is considerably more detailed and contain more stringent requirements than the draft. For instance, the requirements with regard to the quality assurance system of distributors for APIs are much more detailed and demand the tracking and documentation of deviations and a CAPA system.
The guidelines on GDP for APIs 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.
Distributors of active substances for medicinal products for human use should follow these guidelines as of 21 September 2015.
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