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Growth Promotion Testing (GPT) verifies culture media performance to support microbial growth in pharmaceutical microbiology applications.
Discover global strategies for FDA Inspection Readiness, real-time GMP compliance, and regulatory confidence.
Learn how to write a GMP-compliant User Requirement Specification (URS) with regulatory guidance, risk-based principles, and its role in the V-model lifecycle.
Learn how to build a risk-based Contamination Control Strategy (CCS) that meets Annex 1 (2022) expectations. Discover the key elements, risk tools like FMEA & HACCP, and how to link controls to contamination risks across the pharma industry.
Explore GMP cleanroom classifications A to D, ISO equivalents, particle & microbial limits, and key qualification steps for contamination control.
Explore the full lifecycle of GMP deviation management—from detection and investigation to CAPA and trending for regulatory compliance and quality assurance.
Draft ICH E6(R3) Annex 2 provides updated GCP guidelines for modern clinical trials, focusing on decentralized designs, data privacy, and participant safety....
USP releases early adoption guidelines for non-animal endotoxin testing, promoting sustainable recombinant Factor C methods with strict validation standards....
he FDA inspection at MedOffice Saglik Endustri Anonim Sirketi revealed significant CGMP violations that could jeopardize product quality and consumer safety. Issues ranged from inadequate...
EDQM releases draft chapter 5.38 on data quality in pharma, emphasizing standards, governance, and SME involvement....
FDA issues a Warning Letter to Diamond Chemical Co., Inc. for cGMP violations, highlighting deficiencies in component testing, batch release, process validation, and stability testing....
Bionpharma Inc. has issued a recall for Atovaquone Oral Suspension due to contamination with Cohnella bacteria....
