Pharmaceutical Quality

FDA Warning Letter: CGMP and Aseptic Processing Violations

by

FDA Warning Letter: CGMP and Aseptic Processing Violations This FDA Warning Letter highlights significant regulatory and quality-system deficiencies identified during an FDA inspection of a facility producing compounded drug products. The FDA identified concerns involving Section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act), aseptic processing, sterile drug manufacturing, CGMP compliance, media … Read more

Quality Risk Assessment New Product Introduction: Non-Sterile Soft Gelatin Capsules

by

Quality Risk Assessment – New Product Introduction: Non-Sterile Soft Gelatin Capsules Objective: Identify, assess, and control quality risks before commercial manufacture of a new soft gelatin capsule product. 1. Formulation Risks API–excipient incompatibility API degradation / oxidation / hydrolysis Fill viscosity and uniformity Solubility and precipitation Over/under-fill risk 2. Gelatin Shell Risks Gelatin–fill interaction Shell thickness … Read more