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Improving Investigations: An Inspector’s Perspective

Facility inspections continue to be on the minds of both drug manufacturers and regulators. Over the past year, we’ve discussed the challenges surrounding inspections in our Maintaining Quality and Supply…

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Update on Regulatory Guidance for Facility Inspections

During the initial outbreak of the COVID-19 pandemic, travel and social distancing restrictions had a significant impact on regulatory inspections. In March of 2020, hands-off policies quickly became the new…

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On-Site Pharma Audits During the Coronavirus (COVID-19) Crisis

The outbreak of COVID-19 has significantly impacted physical visits to drug manufacturing facilities. This raises a number of challenges, since many regulations — especially those relating to inspections — weren’t written with…

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Valsartan Contamination: A Follow-Up

Following up on our earlier post on the 2018 valsartan contamination, much has happened over the last six months. In our original post, we discussed the appearance of impurities in…

Posted in APIs, CMC, drugs, FDA, genotoxic impurities, Impurity profile, process chemistry, QA/QC, regulatory | Tagged , , , , , , | Comments Off on Valsartan Contamination: A Follow-Up

Fostering a Quality Culture to Support Drug Manufacturing

As an API manufacturer, when it comes to product safety in the pharmaceutical space the stakes couldn’t be higher. We’ve written a few posts recently on modifications to regulatory inspection…

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What the Revised FDA CDER SSM Really Means

Confused by the new FDA CDER Site Selection Model? Here’s what you need to know. CDER – the U.S. FDA’s Center for Drug Evaluation and Research which regulates over-the-counter and…

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Drug Manufacturing: Implications of the U.S. – E.U. Mutual Recognition Agreement

In July, the United States and European Union finalized a Mutual Recognition Agreement (MRA) for drug manufacturing inspections. Both parties have now fully implemented the MRA for specific therapeutics in…

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Non-Cytotoxic Drug Compounds & India’s GMP Schedule M

Drug product volumes have been shrinking as increasingly niche products emerge to treat various conditions. Coupled with the rise of pharmaceutical manufacturing outsourcing, this has led to a reconsideration of…

Posted in APIs, Chemistry, Contract Manufacturing, cytotoxic, drugs, FDA, Neuland Labs, oncology, regulatory, Schedule M | Tagged , , , , | Comments Off on Non-Cytotoxic Drug Compounds & India’s GMP Schedule M