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What’s the difference between HPLC and UPLC? Compare speed, cost, resolution, and regulatory fit for pharmaceutical analysis.
Even modern cleanrooms face mold risks from HVAC systems, materials, and humidity. Understand how maintenance and monitoring programs can prevent costly contamination.
Explore risk-based software validation in GMP, from CSV to continuous assurance, ensuring compliance, data integrity, and efficiency.
Explore how risk management in CSV optimizes validation by focusing on critical functions, ensuring compliance and efficient use of resources.
Discover the key differences between CSV and CSA in pharma, shifting from document-heavy compliance to risk-based assurance
Explore ALCOA++ in GMP: practical data integrity principles that keep records accurate, traceable, and inspection-ready.
FDA’s 2025 CSA guidance introduces a risk-based approach to software assurance, reducing burden and aligning with ISO 13485:2016 compliance....
FDA issues Warning Letter to Somerset Therapeutics citing major cGMP failures in aseptic practices, investigations, and reporting....
Draft revisions to GMP Chapter 1 focus on risk-based oversight, early warning systems, supply chain risks, and improved Product Quality Reviews....
USP–NF PF 51(5) draft introduces updates in microbiology, transport, particulates, and dosage form guidance, emphasizing risk-based GMP compliance....
PDG updates Q09 on sub-visible particulate contamination after 20 years, harmonising standards for safer parenteral medicines....
ICH Q3E draft outlines global guidance for Extractables & Leachables, covering scope, risk assessment, AET, and regulatory expectations....
