This document is based on the EU Commission Guideline on the principles of Good Distribution Practice of active substances for medicinal products for human and veterinary use and therefore follows the same structure.
This APIC document provides guidance on practical approaches, with examples, for applying the principles of the EU GDP guideline for APIs.
The APIC document applies to steps in the distribution/supply chain starting from the point at which an API is transferred outside the control of the original manufacturer’s material management system.
Some sections and/or sub-sections of this document may not apply to all parties involved. This document is intended to provide guidance on the application of GDP; however, alternative approaches may be acceptable.
Specific guidance on storage conditions is described in regulatory documents such as USP chapter <659> Packaging and Storage Requirements and the EMEA Guideline on Declaration of Storage Conditions CPMP/QWP/609/96/Rev 2 (EMEA 2007).