Quality Assurance

Quality Risk Management Methods and Tools: Powerful Guide for Effective and Positive Risk Control

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Quality Risk Management Methods and Tools: Powerful Guide for Effective and Risk Control Quality Risk Management Methods and Tools provide structured approaches for identifying, evaluating, controlling, communicating, and monitoring risks that may affect pharmaceutical products, processes, facilities, and systems. The purpose of Quality Risk Management Methods and Tools is not to require one specific technique … Read more

FDA Warning Letter: Major CGMP Violations and Required Remediation

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FDA Warning Letter: Major CGMP Violations and Required Remediation The FDA warning letter identifies significant violations of Current Good Manufacturing Practice (CGMP) requirements for finished pharmaceuticals. The FDA determined that the firm’s methods, facilities, and controls for manufacturing, processing, packing, or holding drugs did not conform to CGMP requirements under 21 CFR Parts 210 and … Read more

FDA Warning Letter: Major Sterility, CAPA, Environmental Monitoring and CGMP Violations

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FDA Warning Letter: Major Sterility, CAPA, Environmental Monitoring and CGMP Violations The FDA Warning Letter reviewed in this article identifies significant Current Good Manufacturing Practice (CGMP) deficiencies at a pharmaceutical facility involved in the manufacture of sterile injectable drug products. The inspection was conducted under the authority of the U.S. Food and Drug Administration (FDA) … Read more

FDA Warning Letter: Major Data Integrity, Aseptic Processing and CGMP Violations at Reliance Life Sciences

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FDA Warning Letter: Major Data Integrity, Aseptic Processing and CGMP Violations at Reliance Life Sciences The FDA Warning Letter concerning Reliance Life Sciences Private Limited, Navi Mumbai, India, highlights serious deficiencies in Current Good Manufacturing Practice (CGMP) compliance, laboratory data integrity, microbiological testing, aseptic processing, cleaning and maintenance, quality-unit oversight, and contamination control. The inspection … Read more

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, Aseptic Processing and Microbiological Contamination Violations

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FDA Warning Letter: Major CGMP, Aseptic Processing and Microbiological Contamination Violations This FDA Warning Letter highlights significant violations of Current Good Manufacturing Practice (CGMP) requirements identified during an FDA inspection of a manufacturer of sterile prescription and over-the-counter (OTC) drug products. FDA determined that the firm’s manufacturing methods, facilities, and controls for manufacturing, processing, packing, … Read more

FDA Warning Letter: CGMP and Aseptic Processing Violations

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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

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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

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