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GMP Insiders Expert Team
The GMP Insiders Expert Team is a group of seasoned professionals specializing in quality assurance, regulatory compliance, and operational innovation in pharmaceutical and biotech manufacturing. United by a passion for advancing Good Manufacturing Practices, they transform complex compliance challenges into clear, actionable strategies that drive operational excellence.
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Latest GMP Posts
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 GMP.
Media fill tests verify aseptic process integrity by simulating sterile drug manufacturing under worst-case conditions to ensure contamination control.
USP–NF PF 51(4) introduces draft chapters on data integrity, suspensions, disinfectants, chemometrics, and analytical lifecycle, impacting GMP pharma operations.
Overview of Bill of Materials in GMP-compliant pharmaceutical manufacturing, including materials, compliance, traceability, version control, and integration.
Essential strategies for environmental monitoring in pharma to ensure GMP compliance, prevent contamination, and maintain cleanroom control.
MDCG 2019-11 Rev.1 updates software qualification and classification under MDR/IVDR with new rules, modular guidance, and conformity insights.
