PHARMA MANUFACTURERS TO COMMENT ON NEW EU QUALIFICATION AND VALIDATION GMP DRAFT
March 1st, 2014
EUROPEAN Union (EU) pharmaceutical manufacturers have been asked to comment on a new draft set of EU good manufacturing practice (GMP) guidance on qualification and validation. The European Commission has been updating this guidance taking account of new best practice and technology, and is due to authorise these revised GMP rules in October.It is consulting on a new text for Annex 15 of the EU’s GMP system, which covers validating the quality of facilities, equipment, utilities and medicine manufacturing processes.A key shift in the new next is a priority ...
Full access to this article can be arranged with permission from the client that first ordered it. Please contact us to request access. Entries are uploaded to our archive at least one year after being published by a client – free access is restricted to International News Services journalists for background research only. The article date indicates when copy was filed to a client, not when posted to this archive. Upon client requests, International News Services will remove such articles from the archive or not upload them in the first place. They are included to demonstrate the breadth of topics undertaken by the agency and also to help promote clients’ coverage.