Latest Articles
Most Popular
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.
Explore Annex 1 PUPSIT requirements, causes of filter damage, and how proactive integrity testing strengthens sterility assurance in aseptic processing.
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....
Annex 22 - EU's new draft regulatory framework for AI in GMP, focusing on model validation, performance, and risk management for quality and safety....
The 2025 EU GMP draft revisions to Chapter 4, Annex 11, and Annex 22 bring major changes to documentation, computerized systems, and AI integration in...
USP–NF PF 51(4) introduces draft chapters on data integrity, suspensions, disinfectants, chemometrics, and analytical lifecycle, impacting GMP pharma operations....
