GMP Compliance

FDA Warning Letter: Major CGMP Violations in Raw Material Testing, Stability, Validation and Quality Systems

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FDA Warning Letter: Major CGMP Violations in Raw Material Testing, Stability, Validation and Quality Systems This FDA Warning Letter highlights significant violations of Current Good Manufacturing Practice (CGMP) requirements identified during an FDA inspection of a pharmaceutical manufacturing facility. The inspection found deficiencies involving raw material and API identity testing, supplier qualification, stability testing, Quality … Read more

FDA Warning Letter: Major CGMP, Stability, OOS and Storage Violations

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FDA Warning Letter: Major CGMP, Stability, OOS and Storage Violations The FDA warning letter issued highlights identifies significant Current Good Manufacturing Practice (CGMP) deficiencies observed during an FDA inspection conducted from March 31 to April 3, 2026, at the firm’s drug manufacturing facility in Chatsworth, California. The FDA warning letter states that the firm’s methods, … Read more

Pharmaceutical Quality Risk Management: FDA & ICH Q9 Guide

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Quality Risk Management for New Products, Processes, Equipment, Facilities, Technology Transfer and Scale-Up   Introducing a new pharmaceutical product, manufacturing process, equipment, facility modification, technology transfer, scale-up activity, or process change can create significant quality risks. A change that appears technically simple may affect: Critical Quality Attributes (CQAs) Critical Process Parameters (CPPs) Material attributes Process capability … Read more