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The USP proposes two new general chapters <665> and <1665> to address the qualification of polymeric components used in the manufacture of pharmaceutical and biopharmaceutical APIs and drug products. Chapter <665> was previously published as Plastic Components and Systems Used in Pharmaceutical Manufacturing <661.3>. Read more about the proposals for Polymeric Components and Systems Used in the Manufacturing of Pharmaceutical and Biopharmaceutical Drug Products and Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products.
Because of various severe GMP violations, the FDA issued a warning letter to an American manufacturer of wound disinfactants. The authority especially criticised deviations in monitoring of microbiological environments. Read the more about the Warning Letter to Aplicare from December 2016.
An article from April reported about the publication of inspection results by the British MHRA for 2016. Amongst other things, this publication addresses deficiencies concerning validation/qualification.