Comments on: IPEC Regulatory Conference Coverage: More Calls to Action http://blog.pharmtech.com/2009/10/06/ipec-regulatory-conference-coverage-more-calls-to-action/ The blog of Pharmaceutical Technology magazine Thu, 09 May 2013 23:30:55 -0400 http://wordpress.org/?v=2.8.4 hourly 1 By: SCB http://blog.pharmtech.com/2009/10/06/ipec-regulatory-conference-coverage-more-calls-to-action/comment-page-1/#comment-21755 SCB Tue, 13 Oct 2009 05:07:45 +0000 http://blog.pharmtech.com/?p=1883#comment-21755 It is beginning to look as though the time is ripe to build a consensus for regulation of pharmaceutical excipient manufacturing and quality. It seems unlikely that user audits and user assurance of excipient quality will become widely accepted and credible until agencies include some requirements in their regulations - perhaps something similar to the EU regulations for Drug Product Manufacturer oversight of the GMP conformance of firms which manufacture and supply their APIs, probably with (some) audits performed by accredited independent 3rd parties, as well as regulatory audits by agencies. As Dave Schoneker says, various sensible options such as these have been adequately discussed in the IPEC forum, its now time for practical planning, including appropriate levels of action and resourcing decisions. It is beginning to look as though the time is ripe to build a consensus for regulation of pharmaceutical excipient manufacturing and quality.
It seems unlikely that user audits and user assurance of excipient quality will become widely accepted and credible until agencies include some requirements in their regulations – perhaps something similar to the EU regulations for Drug Product Manufacturer oversight of the GMP conformance of firms which manufacture and supply their APIs, probably with (some) audits performed by accredited independent 3rd parties, as well as regulatory audits by agencies.
As Dave Schoneker says, various sensible options such as these have been adequately discussed in the IPEC forum, its now time for practical planning, including appropriate levels of action and resourcing decisions.

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