EMA Guideline shared facilities

The cross-contamination meaning the contamination from one product to another one, is considered as one of the highest risks for patients using pharmaceutical products. Managing risk of cross contamination is a growing priority for the pharmaceutical-industry actors in recent years.

The European Commission published an update of the chapter 3 (premises & equipment) and 5 (production) in January 2015 in order to minimize the risk of cross contamination; these revisions became effective on 1 March 2015.

Almost at the same time, EMA published a guideline EMA/CHMP/CVMP/SWP/169430/2012 on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities in November 2014, applicable since June 1st 2015.

This new guideline has massive impact on the calculation of limits for cleaning validation when different medicinal products are produced in shared facilities. It also introduces the calculation of the Permitted Daily Exposure (PDE) of an active substance, described in Annex 3 of ICH Q3C (R4) Impurities and Annex 3 of VICH GL 18 and based on a structured scientific evaluation of all available pharmacological and toxicological data including both non-clinical and clinical data.

We elaborate some customized PDE monographs for all your products concerned by this risk of cross contamination. Access directly to our database which contains more than 1,000 PDEs already developed.

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