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Thursday, 24 February 2011

EU Annex 11 – Supplier Audits

Posted on 08:02 by Unknown
This is a continuation of a review of the impact of the update to EU Annex 11, issued in January 2011 to become effective on the 30 June 2011.

Supplier AuditsThe supplier audit process for software suppliers including IT systems, automation systems, etc has been around for quite some time within the guidance documents, but never directly referenced within cGMPs for pharmaceutical companies (e.g.
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