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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ICH E6(R3) Annex 2: Draft Version for Good Clinical Practice in Modern Clinical Trials

ICH E6(R3) Annex 2: Draft Version for Good Clinical Practice in Modern Clinical Trials

Draft ICH E6(R3) Annex 2 provides updated GCP guidelines for modern clinical trials, focusing on decentralized designs, data privacy, and...
Introduction to Good Manufacturing Practices (GMP)

What Is Good Manufacturing Practices (GMP)?

Good Manufacturing Practice (GMP) ensures pharmaceuticals are produced consistently with high standards for quality, safety, and efficacy, protecting patient health....
USP Introduces New Chapter for Early Adoption Non-Animal Derived Endotoxin Testing Methods

USP Introduces Chapter <86> Bacterial Endotoxins Test Using Recombinant Reagents for Early Adoption

USP releases early adoption guidelines for non-animal endotoxin testing, promoting sustainable recombinant Factor C methods with strict validation standards....
Good Chromatography Practices – Meeting Industry Standards

Good Chromatography Practices – Meeting Industry Standards

Learn how Good Chromatography Practices enhance data integrity, ensure compliance, and boost efficiency in pharmaceutical labs for reliable, safe product...
fda-warning-letter-analysis

FDA Warning Letter: MedOffice Saglik Endustri Anonim Sirketi

he FDA inspection at MedOffice Saglik Endustri Anonim Sirketi revealed significant CGMP violations that could jeopardize product quality and consumer...
10 Tips on How to Prepare for a GMP Inspection

10 Tips on How to Prepare for a GMP Inspection

Prepare for GMP inspections with these 10 tips, including audits, updated documentation, staff training, mock inspections, and setting up a...
Powders, Granules, and Tablets: What is the Difference

Powders, Granules, and Tablets: What is the Difference

Explore the key differences between powders, granules, and tablets in pharmaceuticals, including their advantages, disadvantages, and manufacturing approaches....
Draft EDQM General Chapter 5.38 Quality of Data

Draft EDQM General Chapter 5.38: Quality of Data

EDQM releases draft chapter 5.38 on data quality in pharma, emphasizing standards, governance, and SME involvement....
Evaluation of Out of Trend Results in Pharmaceutical Industry

Out of Trend (OOT) Results in Pharma Industry

Learn how to detect, manage, and investigate Out-of-Trend (OOT) results in pharma to maintain product quality, ensure GMP compliance, and...
Toxic Solvents Used in Reversed Phase Chromatography

Toxic Solvents Used in Reversed Phase Chromatography

Explore the impact of toxic solvents in Reversed Phase Chromatography, their risks, and eco-friendly alternatives to ensure safe, accurate testing...

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