Risk-assessment for excipients: guideline out for comment
pharmafile | March 4, 2013 | News story | Manufacturing and Production |Â Â GMP, riskÂ
The European Commission has published its long-awaited risk-assessment guideline for determining the level of Good Manufacturing Practice (GMP) needed for pharmaceutical excipients, and is seeking comments on the draft until 30 April.
The consultation document is designed to meet the requirement for risk assessments for excipients, which was introduced by articles 46(f) and 47 of the Falsified Medicines Directive (FMD) and tries to bring the EU GMP rules into line with ICH’s Q9 document on Quality Risk Management.
The document notes that the excipient risk assessment/risk management procedure should be incorporated in the Quality Management System of the Manufacturing Authorisation Holder (MAH).
It is split into three sections and provides guidance on: how to assess and rank the risk (low, medium or high) presented by an excipient; how to determine an excipient supplier’s risk profile; and finally the various approaches that need to be taken by the finished product manufacturer to ensure that appropriate GMP levels are being applied on an ongoing basis.
The document called for MAHs to carry out a gap analysis on suppliers to compare the level of GMP required and see if there are any deficiencies with the manufacturer’s capabilities.
Excipients industry group IPEC Europe said it has set up a working group to analyse the EC’s proposals and is working on a response to the document.
The topic of GMPs for excipients has been a controversial one for years, with the European Commission’s attempt to develop a Directive on the issue abandoned in 2009 after a lengthy consultation process, which raised concerns that the implementation costs of GMP for excipients could be greater than the potential safety benefits for patients.
The adoption of the FMD brought the topic to a head once again. Once articles 46(f) and 47 were introduced fears expressed by some industry groups – including the European Federation of Pharmaceutical Industries & Associations (EFPIA) – that the articles added layers of regulation where none were needed.
EFPIA noted in a position paper last year that ensuring excipients are fit for purpose is already covered by Chapter 5 of the EU GMP guide, which requires that MAHs have vendor management systems in place.
Phil Taylor
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