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Warning Letters from 2012 – Q1 2014 Show FDA’s GMP Enforcement Focus Shifting Overseas; Foreign Labs Draw Particular Attention

An analysis of FDA drug GMP warning letters issued since the beginning of 2012 highlights the agency’s increasing focus on enforcement outside the US – and on laboratory practices at foreign facilities, in particular....

EDQM Publishes First Monthly Report on Certification of Substances

The European Directorate for the Quality of Medicines (EDQM) has published its first monthly report on the Certification of Substances Division (DCEP) The September report notes that the DCEP received 32 new certification (CEP) requests in September and approved 20.  It also received 122 revisions, including notifications and renewals, and suspended or withdrew five CEPs. […]

FDA’s Foreign Office Experience Supports Their Benefit to Global Supply Chain Regulation

FDA’s growing experience with the field offices it has established in India, China and eight other countries is substantiating their benefit in boosting the agency’s efficiency and effectiveness in regulating a global supply chain....

International Joint API Inspection Pilot Program Sees Positive Results

The international API pilot joint inspection program involving regulatory authorities in the EU, US, and Australia is resulting in rapid sharing of inspection reports for non-compliant sites, follow-up inspections at other facilities owned by the companies found to have non-compliant sites, and prompt notification of regulatory actions taken....

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CLICK HERE  for the IPQ Monthly Update – November/December 2020 in Review


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