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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EU GMP Guidelines draft updates: Chapter 4, Annex 11, and new Annex 22 - What is about to change?

2025 EU GMP Draft Updates: Chapter 4, Annex 11, and Annex 22 – What’s Changing?

The 2025 EU GMP draft revisions to Chapter 4, Annex 11, and Annex 22 bring major changes to documentation, computerized...
Media Fills In Sterile Manufacturing: Aseptic Process Simulation - Featured Image of Article

Media Fill Tests: Aseptic Process Simulation (APS) in Sterile Manufacturing

Media fill tests verify aseptic process integrity by simulating sterile drug manufacturing under worst-case conditions to ensure contamination control....
USP Releases New Draft Proposals in Pharmacopeial Forum 51(4) - Featured Image

USP–NF PF 51(4) Draft Published

USP–NF PF 51(4) introduces draft chapters on data integrity, suspensions, disinfectants, chemometrics, and analytical lifecycle, impacting GMP pharma operations....
Bill of materials in pharmaceutical manufacturing - featured image

Bill of Materials (BOM) in Pharmaceutical Manufacturing

Overview of Bill of Materials in GMP-compliant pharmaceutical manufacturing, including materials, compliance, traceability, version control, and integration....
environmental monitoring in pharmaceutical industry - featured image

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...

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