Data Integrity

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, 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

Pharmaceutical eQMS Digitalization FDA Compliance

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Pharmaceutical eQMS & Digitalization FDA Compliance: A Practical Guide for FDA-Regulated Companies Digital transformation is changing how pharmaceutical companies manage quality, compliance, documentation, and operational risk. For many years, pharmaceutical Quality Assurance departments relied heavily on paper-based systems, spreadsheets, email approvals, and manually maintained quality records. While these approaches can support basic operations, they can … Read more