Process Validation

FDA Warning Letter: API Process Validation, Batch Records, Analytical Methods, and Stability Deficiencies

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What happened FDA states that its records review identified significant CGMP deviations at Tianjin Kilo Pharmaceutical Sci-tech Co., Ltd., an API manufacturer. The firm manufactured and distributed APIs to U.S. 503A compounding pharmacies without adequate process validation; it had described the APIs as still in development and said formal documents, including SOPs, were not finalized. … Read more

FDA Warning Letter: Zydus Lifesciences cited for contamination, aseptic processing, and PPQ deficiencies

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What happened FDA inspected Zydus Lifesciences Limited in Gujarat from April 15 to 23, 2024, and cited significant CGMP violations involving investigations, aseptic processing, and process validation. FDA stated that multiple cross-contamination events over about three months were linked to inadequate cleaning of shared equipment. Investigations did not cover all potentially affected batches, equipment, product-contact … Read more