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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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...
FEFO vs FIFO vs LIFO: What Is the Difference?

FEFO vs FIFO vs LIFO: What Is the Difference?

Discover the key differences between FEFO, FIFO, and LIFO in pharmaceutical inventory management. Learn how each method impacts regulatory compliance,...
fda-warning-letter-analysis

FDA Warning Letter Analysis: Diamond Chemical Co., Inc.

FDA issues a Warning Letter to Diamond Chemical Co., Inc. for cGMP violations, highlighting deficiencies in component testing, batch release,...
Types of Sampling Methods in Environmental Monitoring

Types of Sampling Methods in Environmental Monitoring

Explore key sampling methods in environmental monitoring, like air, surface, and personnel sampling, to ensure GMP compliance and maintain cleanroom...
batch recall of atovaquone oral suspension due to bacterial contamination

Bionpharma Inc. Recalls Batch of Atovaquone Oral Suspension Due to Contamination

Bionpharma Inc. has issued a recall for Atovaquone Oral Suspension due to contamination with Cohnella bacteria....
Granulation Process in Pharmaceutical Manufacturing

Granulation Process In Pharmaceutical Manufacturing

Learn about the granulation process in pharmaceutical manufacturing, its types, equipment, and role in improving flowability, compressibility, and product quality...
FDA Releases Updated Guidance on Controlling Nitrosamine Impurities in Human Drugs

FDA Releases Updated Guidance on Controlling Nitrosamine Impurities in Human Drugs

FDA's 2024 guidance on nitrosamine impurities introduces new limits, testing methods, and timelines, focusing on NDSRIs to enhance drug safety...
RP vs NP Chromatography: Key Differences Explained

RP vs NP Chromatography: Key Differences Explained

Discover the key differences between RP-HPLC and NP-HPLC. Learn how these contrasting chromatography techniques drive effective compound separation and analysis...

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