Happy New Year, and welcome to Insider issue #32.
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In our last pharma feature of 2024, Judson Russell examines the FDA's September 2024 guidance on controlling nitrosamine impurities in human drugs. He breaks down the critical requirements for detection, testing, and mitigation of these carcinogenic compounds while providing practical strategies for manufacturers to implement effective control measures. Judson offers valuable insights on why these recommendations may soon evolve into enforceable requirements.
Our medical device section features Dharmesh Patel's detailed breakdown of the FDA's final guidance on medical device remanufacturing. His analysis clarifies the crucial distinction between servicing and remanufacturing activities, exploring the significant regulatory implications for both OEMs and third-party servicers. Dharmesh provides a practical framework for implementing compliant remanufacturing assessment processes while maintaining operational efficiency.
Finally, Leon Chagal examines a revealing warning letter issued to Clean Solutions LLC, an OTC drug manufacturer in New Jersey. The letter uncovers serious CGMP violations in component testing, quality control, and process validation. Our analysis provides a comprehensive breakdown of the deficiencies and detailed recommendations for establishing robust quality systems that ensure regulatory compliance.
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