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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....
Growth Promotion Testing (GPT) verifies culture media performance to support microbial growth in pharmaceutical microbiology applications....
ICH releases draft M4Q(R2) to modernize CTD Quality Modules, aligning pharma submissions with QbD, lifecycle, and digital data expectations....
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...
Revised EDQM guideline explains how to read a CEP, covering CEP 2.0, site details, impurities, and regulatory declarations for better...
Learn how to build a risk-based Contamination Control Strategy (CCS) that meets Annex 1 (2022) expectations. Discover the key elements,...
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...

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