EU Commission publishes long-awaited EU GMP Guide Chapters 3 and 5

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The EU Commission has published the long-awaited, revised chapters 3 and 5 of the EU GMP Guide. The change focuses on the prevention of cross-contamination as well as on the statement concerning the need for dedicated facilities. Continue reading.

http://www.gmp-compliance.org/enews_4499_EU-Commission-publishes-long-awaited-EU-GMP-Guide-Chapters-3-and-5_9086,8427,8526,Z-PEM_n.html

The EU Commission had published its first draft of the chapter 3 “Premises and Equipment” and 5 “Production” for comments in early 2013 (see news from 04/12/2013). The content concerns the measures for avoiding cross-contamination and the regulation relative to which products have to be produced in dedicated facilities.

The mention of specific products for which a dedication is required – as provided in the currently valid version of chapter 3 – is missing in the now published version. The quality risk management approach is maintained. Also remaining are the exceptions where dedication is required – which are:

• The risk cannot be adequately controlled by operational and/ or technical measures…