Author: 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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Environmental Monitoring in the Pharmaceutical Industry

Essential strategies for environmental monitoring in pharma to ensure GMP compliance, prevent contamination, and maintain cleanroom control....
mdcg-2019-11-rev.1-mdr-news

MDCG 2019-11 Rev.1: Updated Guidance on Software Qualification and Classification under MDR and IVDR

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) in pharmaceutical microbiology

Growth Promotion Testing (GPT) in Pharmaceutical Microbiology

Growth Promotion Testing (GPT) verifies culture media performance to support microbial growth in pharmaceutical microbiology applications....
ICH Publishes a Draft M4Q(R2) guideline on common technical dossier (CTD)

ICH Publishes Draft M4Q(R2) Guideline to Transform CTD Quality Modules for Pharma Submissions

ICH releases draft M4Q(R2) to modernize CTD Quality Modules, aligning pharma submissions with QbD, lifecycle, and digital data expectations....
FDA Inspection Readiness Guideline: How to prepare for unannounced global audits

FDA Inspection Readiness: How to Prepare for Unannounced Global Audits

Discover global strategies for FDA Inspection Readiness, real-time GMP compliance, and regulatory confidence....
How to write a gmp compliant user requirement specification in pharma - featured image

How to Write a GMP-Compliant User Requirement Specification (URS)

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 on how to read a CEP

EDQM Publishes Revised Guideline on How to Read a CEP

Revised EDQM guideline explains how to read a CEP, covering CEP 2.0, site details, impurities, and regulatory declarations for better...
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Risk-Based Contamination Control Strategy (CCS)

Learn how to build a risk-based Contamination Control Strategy (CCS) that meets Annex 1 (2022) expectations. Discover the key elements,...
GMP Cleanroom

GMP Cleanroom Classifications: Grade A, B, C and D

Explore GMP cleanroom classifications A to D, ISO equivalents, particle & microbial limits, and key qualification steps for contamination control....
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Deviation Management Process in GMP

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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