Stability Testing

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

Quality Risk Evaluation for New Product Introduction Non-Sterile Oral Liquid Dosage Forms

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Quality Risk Assessment for Solid Oral Dosage Forms for New Product Introduction OBJECTIVEEvaluate and control quality risks before introducing a new oral liquid product to ensure patient safety, product quality, process robustness, and GMP compliance. KEY RISK AREAS 1️⃣ Product & Formulation API–excipient compatibility Solubility / suspension characteristics CQAs: assay, pH, viscosity, microbial limits Preservative … Read more