Published: 23 Jul 2020

CQI’s Pharmaceutical Quality group publishes guidance on Good Distribution Practice for Active Substances.

The monograph, produced with the Good Distribution Practices (GDP) Association (An ECA Foundation Interest Group), provides guidance on the interpretation and implementation of the regulatory expectations of GDP for active substances. Built around the format and text of the European Commission’s Guidelines on principles of Good Distribution Practice of active substances for medicinal products for human use (2015/C 95/01), published in March 2015, it includes guidance from experts drawn from the membership of both PQG and ECA.  

The monograph borrows from the PQG medicinal product GDP monograph, as many of the good practices apply to both products and active substances. It also reflects the fact the regulatory guidelines for active substances are less detailed and that a risk-based approach allows for some differences between the distribution of medicinal products and active substances. 

Although based on the European guidelines, the advice and guidance provided in the monograph is relevant to all geographical regions given that today’s pharmaceutical supply chains are frequently global with many distribution steps through which quality must be maintained. It provides a sound basis for the implementation and maintenance of a GDP quality system for active substances with clear responsibilities and processes and the application of risk management principles. It will benefit all involved in active substance distribution activities for initial training, continuing professional development, and as a reference source or audit tool. 

For more information please contact PQG.