IPEC e-newsletter - Excipients Insight November/December 2013 - 20-12-13


Inside this issue


EU Commission publishes comments on GMP guide revisions

The EU Commission has published comments on draft updates to four chapters in its Good Manufacturing Practice (GMP) guide on its website.

The parts under revision are Chapter 3 (Premises and Equipment), Chapter 5 (Production), Chapter 6 (Quality Control) and Chapter 8 (Complaints and Product Recall).  

The main changes are to paragraph 6 of Chapter 3 - which covers prevention of cross contamination - and a series of supportive amendments to Chapter 5 with the same objective. The revisions also bring the GMP guide into line with new guidance on dedicated facilities which was published recently by the European Medicines Agency (EMA).

The cross-contamination elements attracted the most comment, with some commentators - including the European Federation of Pharmaceutical Industries & Associations (EFPIA) - pointing to possible problems with exposure limits that may not be available for some compounds.

IPEC Europe submitted its own comments on the Chapter 5 revisions, which mainly concern paragraphs 17 to 20 on cross-contamination and paragraphs 26 to 28 on qualification of suppliers.

According to the draft text, pharmaceutical manufacturers must now ensure that all the starting materials used originate from controlled sources and where possible directly from the manufacturer of the material. IPEC has asked that this text be modified to allow purchase from "a suitably qualified and approved distributor", pointing out that this can be done whilst still meeting traceability and supply chain security requirements.

IPEC Europe has also asked for clarification on paragraph 27, which states that "excipients which are considered to pose a particular risk to the quality of the medicinal product, based on formalised quality risk management, should be given similar attention to those for active substances". The response points out that 'particular risk' is not well defined, and that "all excipients and excipient suppliers should be controlled appropriately," not only those that pose such a risk.

The comments also ask for some flexibility on the requirement for finished product manufacturers to audit sites making starting materials, noting that it would be useful if this could be performed by "appropriately-trained" third-parties. The change would allow the use of third-party audit of sites in accordance with standards set by certification bodies such as EXCiPACT.




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