
Latest Articles
Most Popular
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.
Learn about stability storage conditions in pharma, including long-term, intermediate, and accelerated studies, climatic zones, regulatory guidelines, and strategies for preserving drug quality, safety, and efficacy across diverse environments.
Good Manufacturing Practice (GMP) ensures pharmaceuticals are produced consistently with high standards for quality, safety, and efficacy, protecting patient health.
Discover the key updates in USP–NF PF 51(2), including revisions to chromatography, analytical instrument qualification, microbial contamination control, solubility measurements, and residual solvent analysis....
CGMP violations identified in the FDA Warning Letter to Marshalls Traditional Healthcare CC, including deficiencies in finished product testing, process validation, and water system control....
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
...
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....