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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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...
Contamination Control Strategy Featured Image

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....
deviation management process featured image

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...
USP-NF PROPOSED DRAFTS IN PF 51(3)

USP–NF PF 51(3) Draft Published

USP–NF PF 51(3) draft introduces new PAT, content uniformity, parenteral leachables, and CBD standards, enhancing GMP control and regulatory alignment....
usp-233 elemental impurities procedures adopt the harmonized standard

Harmonized Standard for USP <233> Elemental Impurities—Procedures Adopted

Discover the 2025 USP update on elemental impurities: key changes, harmonization across pharmacopeias, and compliance insights....

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