Tuesday, 4 November 2014

EU GMP Chapter 3 Premises and Equipment


A new draft of EU GMP Chapter 3 “Premises and Equipment” has been issued by the European Medicines Agency.

The main change from the previous draft is to section 6 as part of the improved guidance on prevention of cross-contamination which states:


 “3.6 Cross-contamination should be prevented 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. Depending of the level of risk, it may be necessary to dedicate premises and equipment for manufacturing and/or packaging operations to control the risk presented by some medicinal products. Dedicated facilities are required for manufacturing when a medicinal product presents a risk because: the risk cannot be adequately controlled by operational and/ or technical measures, scientific data from the toxicological evaluation does not support a controllable risk (e.g. allergenic potential from highly sensitising materials such as beta lactams) or relevant residue limits, derived from the toxicological evaluation, cannot be satisfactorily determined by a validated analytical method.”

For details see: EMA

Posted by Tim Sandle