PIC/S Guidelines on GDP of Active Substances for Medicinal Use

This document provides Pharmaceutical Inspection Convention Cooperation Scheme (PIC/S) Guidelines on the Principles of Good Distribution Practice of Active Substances for Medicinal Products for Human Use  PI 047-1 Annex 01 July 2018.  These guidelines have been adopted by PIC/S as a guidance document.  It is up to each PIC/S Participating Authority to decide whether it should become a legally-binding standard.

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 PIC/S PE 009 GMP Guide Part II:  Basic Requirements for Active Pharmaceutical Ingredient, and apply also to distributors of active substances manufactured by themselves.

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