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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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Author's Latest Publications

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FDA Warning Letter Analysis: Novo Nordisk Inc. and Failures in 15-Day Alert Reporting

FDA Warning Letter analysis of Novo Nordisk’s PADE violations, including missed 15-day Alert reports, weak ADE investigations, vendor oversight gaps,...
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Featured image for GMP Insiders article on FDA draft guidance for responding to Form 483 observations, showing a hand stamping a document beside a laptop.

FDA Draft Guidance on Responding to Form 483 Observations

FDA’s draft guidance on Form 483 responses outlines what drug manufacturers should do on timing, investigation, risk assessment, and effective...
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Fluid bed technology in pharmaceutical manufacturing showing operator monitoring stainless steel processing equipment in a GMP environment.

Fluid Bed Technology in Pharmaceutical Manufacturing: Principles, Applications, and Process Control

Learn how fluid bed technology is used in pharmaceutical manufacturing for drying, wet granulation, and coating, with a practical focus...
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EU GMP Annex 6 revision 2026 concept paper highlights cover image showing medicinal gas cylinder valve and pressure gauges being handled in a controlled manufacturing setting.

EU GMP Annex 6 Revision: Key Points from the 2026 Concept Paper

EU GMP Annex 6 revision (2026 concept paper): premises rationale, valves/couplings, flow-check frequency, hospital liquid oxygen documentation, and batch release....
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EU GMP Annex 15 revision concept paper highlights showing pharmaceutical filling equipment and operator, representing proposed changes to qualification, validation governance, investigations, and lifecycle control for 2026.

EU GMP Annex 15 Revision to Cover Active Substances: Concept Paper Highlights (2026)

EMA & PIC/S consult on revising EU GMP Annex 15 for active substances: scope, Q&V governance, investigations, CPV and GDP...
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Transport validation and GDP compliance featured image showing logistics shipment container and pharmaceutical distribution control message.

Transport Validation and GDP Compliance

Transport validation in GDP: how to qualify lanes and packaging, design studies, manage excursions, and maintain ongoing control with risk-based...
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GMP cleanroom operators performing controlled pharmaceutical manufacturing activities.

Pharmaceutical Cleanrooms: Design, Classes, and Control in GMP Manufacturing

Cleanrooms explained: what they control, ISO 14644 classes vs EU GMP Grades, where they’re used, and how monitoring, trending, and...
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Complaint management and investigation in GMP focusing on risk-based governance, escalation, CAPA linkage, and compliance oversight.

Complaints Management in the Pharmaceutical Industry

Practice-oriented guide to pharmaceutical complaint management: definitions, risk-based triage, investigations, CAPA, recall interfaces, and trending KPIs....
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Moist heat sterilization using an autoclave for pharmaceutical and GMP applications.

What Is Moist Heat Sterilization?

What moist heat sterilization really means in GMP: mechanisms, cycle types, limitations, and regulatory expectations beyond 121 °C for 15...
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EU GMP Annex 11 versus FDA 21 CFR Part 11 comparison for computerized systems and electronic records

Annex 11 vs 21 CFR Part 11: Comparison and GMP Requirements

Comparison of Annex 11 and 21 CFR Part 11, with practical takeaways on validation, governance, risk management, audit trails, electronic...
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