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GMP News

USP Publishes Comments Received on Chapter <320>

In its USP–NF 2027 Issue 1 Commentary, the United States Pharmacopeia (USP) addressed comments received on General Chapter <320> NMR Spectroscopy for the Determination of Degree of Hydrolysis for Polyvinyl Alcohol and Vinyl Alcohol Homopolymer, and Monomer Ratio for Vinyl Alcohol and Vinyl Acetate Copolymer.

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USP Article: Supporting the Detection of Asbestos in Pharmaceutical Talc

The USP has published an article on the implementation of current requirements for asbestos testing in pharmaceutical talc. The article provides an overview for manufacturers, suppliers and contract testing laboratories.

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FDA Warning Letter over Serious Deficiencies in Sterile Manufacturing leads to a Production Shutdown

Failed media fills, high-risk interventions in ISO 5 areas and inadequate smoke studies: The FDA has identified fundamental weaknesses in K.C. Pharmaceuticals’ sterile manufacturing and contamination-control systems. In addition to suspending production and initiating a voluntary recall, the agency is demanding a comprehensive reassessment of drug products already distributed in the United States.

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