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EMEA says clarification on dedicated facilities forthcoming

This article was originally published in The Gold Sheet

Executive Summary

EMEA said a clarification on the status of the revision of Chapter 5 of its EU GMP guide concerning dedicated facilities will be available at the end of the year. Section 6 of Chapter 5 GMP Guide currently states that "in order to minimize the risk of a serious medical hazard due to cross-contamination, dedicated and self-contained facilities must be available for the production of particular medicinal products such as highly sensitizing materials (e.g. penicillins) or biological preparations (e.g. from live microorganisms)." It further noted that "the production of certain additional products such as certain antibiotics certain hormones, certain cytotoxics, certain highly active drugs and non-medicinal products should not be conducted in the same facilities. However, the guidance does not specify which drugs those are. EMEA notes that "at present the GMP/GDP Inspectors Working Group agrees that the guide should indeed identify those products in which the use of dedicated facilities is mandatory. It is acknowledged that the drafting group needs input from toxicological and pharmacological experts in order to develop this part of the guidance so that it is based on well grounded scientific principles and this expertise has now been made available." EMEA says that its Safety Working Party will be developing the guidance and that a consultation draft will be submitted to the European Commission at yearend

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