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Learn the 6 key steps to perform Root Cause Analysis (RCA) in pharmaceutical GMP. Prevent recurrence, improve compliance, and enhance product quality.
Differentiate contamination, cross-contamination, and mix-ups in pharma manufacturing. Discover their causes, impacts, and prevention strategies to ensure GMP compliance.
Explore types of airlocks in pharma: Cascade, Bubble, Sink. Learn how they ensure contamination control, cleanroom integrity, and GMP compliance.
Karl Fischer titration essentials - the gold standard for precise water content determination.
Explore the flow properties of powders and granules in pharma manufacturing. Learn key factors, metrics, and methods ensuring product consistency and efficiency.
Learn how to write SOPs in the pharmaceutical industry. A step-by-step guide on structure, best practices, and ensuring GMP compliance for operational efficiency.
FDA warns ABR Laboratory LLC for failing to validate test methods and investigate deviations, risking drug safety. Learn key compliance takeaways....
On January 30, 2025, the FDA issued a Warning Letter (320-25-37) to Strukmyer LLC dba Strukmyer Medical, following an inspection of its Mesquite, Texas facility
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FDA's January 2025 draft on 21 CFR 211.110 outlines CGMP measures for batch uniformity, drug integrity, and advanced manufacturing innovation...
FDA warns Mylan Laboratories for critical cGMP violations in quality control, data integrity, and governance, urging urgent corrective actions to ensure compliance....
FDA announces a new policy on ethylene oxide sterilization site changes for Class III devices, ensuring supply chain stability and patient safety....
Draft ICH E6(R3) Annex 2 provides updated GCP guidelines for modern clinical trials, focusing on decentralized designs, data privacy, and participant safety....