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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.
RABS vs Isolators: Key differences, Annex 1 expectations, and how to choose the right barrier system for your aseptic manufacturing process.
ICH releases draft M4Q(R2) to modernize CTD Quality Modules, aligning pharma submissions with QbD, lifecycle, and digital data expectations....
Revised EDQM guideline explains how to read a CEP, covering CEP 2.0, site details, impurities, and regulatory declarations for better compliance....
USP–NF PF 51(3) draft introduces new PAT, content uniformity, parenteral leachables, and CBD standards, enhancing GMP control and regulatory alignment....
Discover the 2025 USP update on elemental impurities: key changes, harmonization across pharmacopeias, and compliance insights....
ICH Q1 draft released: a unified guideline for stability testing with new content on lifecycle, in-use studies, modelling, and advanced therapies....
Ph. Eur. adds rFC to BET (2.6.14) and updates pyrogen testing (5.1.13) to support sustainable, animal-free methods in line with modern QC practices....
