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Establishing Health-Based Exposure Limits for Active Pharmaceutical Ingredients. , Nadiad

Admin - Posted on: 19/Jul/2016

As you may know, in November 2014 the European Medicines Agency (EMA) released a guideline with impact on the manufacture of multiple medicinal products in shared facilities. This new guideline outlines requirements and methods for establishing health-based exposure limits that are to be used when evaluating risks related to the possibility of carryover contamination of one drug into another. The guideline (EMA/CHMP/CVMP/SWP/169430/2012), which should be used in conjunction with Good Manufacturing Practices guidelines for medicinal products, took effect on June 1, 2015, meaning that manufacturers and drug companies now need to adhere to the guideline to address potential cross-contamination of active pharmaceutical ingredients (APIs, or drug substances). As noted in the guideline, its aim is to "recommend an approach for deriving a scientifically based threshold value for individual active substances to be applied for risk identification. The guideline outlines how the data on whic

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