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Learn how to write a GMP-compliant User Requirement Specification (URS) with regulatory guidance, risk-based principles, and its role in the...
Explore GMP cleanroom classifications A to D, ISO equivalents, particle & microbial limits, and key qualification steps for contamination control....
Discover the essentials of cold chain management in pharma to ensure the safety and efficacy of temperature-sensitive products like vaccines...
Airflow Visualization Smoke Studies (AVS) ensure cleanroom compliance by visualizing airflow patterns to detect turbulence and verify unidirectional flow, critical...
Learn the essential steps for supplier qualification, ensuring that suppliers meet GMP standards, mitigates risks, and maintains quality in the...
Learn more about Batch Manufacturing Records (BMR), essential for consistent, safe pharmaceutical production and compliance with regulatory standards....
Optimize cleaning validation in pharmaceutical manufacturing with key strategies for selecting worst-case scenarios, ensuring product safety and efficacy....
Explore essential strategies for mitigating risks in temperature-controlled environments, ensuring product stability and safety in pharmaceutical storage....
Explore the crucial role of pharmacovigilance in ensuring medication safety, from detecting adverse effects to proactive risk management....
Explore the crucial roles of Design Review and Design Qualification in the pharmaceutical industry, ensuring equipment meets user needs and...
Explore best practices in environmental monitoring for pharmaceutical cleanrooms, ensuring sterility and safety with comprehensive guidelines and tips....
Explore the essentials of Quality Risk Management in Pharma: Principles, tools, guidelines, and implementation strategies for enhanced safety....
Discover the essential information about impurities in pharmaceuticals, their types, and how they impact drug quality. Learn about regulatory requirements,...
Explore effective strategies for maintaining clear and comprehensive records with our guide on good documentation practices, ensuring accuracy and reliability....
Optimize compliance and quality control in the pharmaceutical industry with eQMS (Electronic Quality Management System). Streamline documentation, enhance regulatory adherence,...
Navigate success in the pharmaceutical industry with GxP compliance. Explore GMP, GLP, GDP, and GCP for quality, safety, and regulatory...
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 the full lifecycle of GMP deviation management—from detection and investigation to CAPA and trending for regulatory compliance and quality...
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....
RABS vs Isolators: Key differences, Annex 1 expectations, and how to choose the right barrier system for your aseptic manufacturing...
Learn the key differences between method validation and verification in pharma labs, with clear guidance on when each applies and...
ICH Q1 draft released: a unified guideline for stability testing with new content on lifecycle, in-use studies, modelling, and advanced...

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