GDP for APIs: Support from APIC "How to" document

Until recently, specific regulations on Good Distribution Practices (GDP) for distributors of APIs were not required. However, with the EU Falsified Medicines Directive (Directive 2011/62/EU) the application of GDP for APIs is now becoming mandatory. The EU Commissions Guideline on the Principles of GDP for APIs will be the first binding regulatory document specifically for the distribution activities of APIs.

With the hope of making the process easier, the Active Pharmaceutical Ingredients Committee (APIC), a sector group of CEFIC, recently published the APIC GDP for APIs "How to" document. This document, written by experts from APIC, is an interpretation of how to implement the Guidelines on the Principles of Good Distribution Practices for Active Substances for Medicinal Products for Human Use, a draft published by the European Commission DG SANCO on February 6th 2013, based on practical experience.

As the guideline describes only the "principles" of GDP, other relevant publications (e.g., ICH Q7 and ISO EN 9001:2008), were taken into account and references included. This guide provides, in particular, additional explanatory notes on the WHO Good Trade and Distribution Practices for Pharmaceutical Starting Materials.

For more information, please click here

In This Same Issue

• Newly expanded Interactive Application Guide available
• Examining single-use MIX vessels with protein solutions