The Active Pharmaceutical Ingredient Committee (APIC) of the European Chemical Industry Council (CEFIC), the trade association representing European chemical manufacturers, has issued a draft “How to” document to provide guidance on good distribution practices (GDPs) for active pharmaceutical ingredients (APIs).
In issuing the draft guidance document, APIC explained that in the recent past, there have been no separate regulations on GDPs for distributors of APIs. The provisions of GMP Part II /ICH Q7, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, for the manufacturers of APIs have been the only guideline partially covering GDPs for APIs. These affect more the handling of APIs at the manufacturing site, but not the distribution outside the site. It noted that the World Health Organization’s guide, Good Trade and Distribution Practices (GDTP) for Pharmaceutical Starting Materials, has been a reference document with broad acceptance in the industry on a voluntary basis. With the EU Falsified Medicines Directive (Directive 2011/62/EU), the application of GDPs for APIs is becoming mandatory. The EU Commission’s guideline on the principles of GDPs for APIs, Principles of Good Distribution Practices for Active Substances for Medicinal Products for Human Use, issued in draft in 2013, will be the first regulatory binding document specifically for distribution activities of APIs.
APIC says its “How to” document is essentially an interpretation of “how to” implement the EU guideline for GDPs for APIs based on practical experience. As the guideline describes only the “principles” of GDPs, other relevant publications (e.g., ICH Q7, ISO EN 9001:2008, The International Pharmaceutical Excipients Council (IPEC) Good Distribution Practices Guide for Pharmaceutical Excipients, 2006) were taken into account and references included in its document. The WHO GTDP document provides the general principles of good practices in the pharmaceutical starting materials supply chain. This APIC document should provide a practical approach with examples that provide guidance on the application of the principles of WHO’s Good Trade and Distribution Practices for Pharmaceutical Starting Materials. In addition, extracts have been taken from IPEC GDP Guide 2006 to clarify certain requirements and maintain consistency. The APIC document does not intend to provide an exhaustive list of “how to” comply with the above mentioned requirements and recommendations. It does, however, provide examples of commonly applied solutions and practical assistance on how requirements and recommendations can be met and /or interpreted. 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.
The APIC document is meant to be a “living document” to describe current practice and to help with the implementation of the EU GDP Guideline for APIs. Suggestions and/or questions from industry or regulators to CEFIC's APIC are encouraged as these suggestions will be discussed regularly by the industry experts and clarifications and improvements incorporated into the document, according to APIC.
Separately, APIC has also issued a guidance on cleaning validation of API plants to assist companies in the formulation of cleaning validation programs.
Source: Active Pharmaceutical Ingredient Committee (CEFIC)