EU Updates GMP Chapter 3 Premises and Equipment

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In August 2014, The European Commission released updated guidelines for  The Rules Governing Medicinal Products in the European Union, Volume 4: EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use as they apply to Chapter 3, Premises and Equipment.

The document was updated in March 2015 to address better prevention for cross contamination, Section 3.6.  This is the only section that was updated and now suggests that dedicated facilities are required when the product presents a risk.  See a,b,c below.

3.6 Cross- contamination should be avoided for all products by appropriate design and operation of manufacturing facilities. The measures to prevent cross-contamination should be commensurate with the risks.   Quality Risk Management principles should be used to assess and control the risks. Risk assessment should include among other parameters a toxicological evaluation of the products being manufactured (see Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities).

Dedicated facilities are required for manufacturing when a medicinal product presents a risk:

(a) which cannot be adequately controlled by operational and/ or technical measures; or

(b) scientific data does not support threshold values (e.g. allergenic potential from highly sensitising materials such as beta lactams); or

(c) threshold values derived from the toxicological evaluation are below the levels of detection.

Further guidance including some exemptions could be found in Chapter 5 and in Annex 2, 3, 4, 5 of the EU detailed guidelines on GMP and the guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities.[1]

[1] http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/document/document_detail.jsp?webContentId=WC500137091&mid=WC0b01ac058009a3dc

Download the guidance document here.