13/14 December 2023
The APIC has recently released a new "How to do" document entitled "Good Distribution Practices for Active Pharmaceutical Ingredients". After the success of "APIC's Interpretation of ICH Q7", the new document is the second one of the "How to do" series developed by the APIC to help interpreting existing regulations.
The introduction of the document explains the historical background of the regulations already existing with regard to the distribution of APIs. Basically, there is no global binding guideline for "GDP". WHO's "Guide on GTDP for Pharmaceutical Starting Materials" is non-binding and the "Guidelines on the principles of Good Distribution practices for Active Substances for medicinal products for human use" dated 6 February 2013 are still in the draft stage. The regulations laid down in GMP Part II/ICH Q7 mainly cover the handling of APIs inside the manufacturing location. Yet, they hardly provide any statement about the shipping out side the company's borders.
Now, the new "How to do" document gives practical tips on GDP in a tabular listing form with regard to the wording of the WHO's GTDP Guide and the APIC's interpretation. This list also contains references to the respective chapters and sections of the "How to do" document as well as to the EU's draft guideline on GDP and the norm ISO 9001:2008. The interpretation also takes into consideration the ICH Q7 guideline and the "Good Distribution Practices Guide for Pharmaceutical Excipients" of the IPEC from 2006.
The new APIC guide is applicable to the supply chain of pharmaceutical starting materials and APIs. Practical information is available about the implementation of the "Good Practices" from the moment when the APIs are no longer under the direct control of the manufacturer.