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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

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...
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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....
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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...
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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...
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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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Validation Master Plan (VMP) In the Pharmaceutical Industry

Validation Master Plan (VMP) In the Pharmaceutical Industry

Learn how to create a comprehensive Validation Master Plan (VMP) to ensure consistent product quality and regulatory compliance...
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Establishment of Expiry Dates for Commercial and In-House Prepared Reagents In QC Labs

Expiry Dates for Commercial and In-House Prepared Reagents In QC Labs

Discover the best practices for establishing and managing expiry dates for commercial and in-house prepared reagents in QC labs....
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FDA Issues Warning Letter to LS Promotions INC. for cGMP Violations

FDA Issues Warning Letter to LS Promotions Inc. for cGMP Violations

FDA issues warning to LS Promotions Inc. for significant cGMP violations. Learn about the key deficiencies, recommended CAPA plan, and...
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Different Types of GMP Documentation Used In Pharma Industry

Explore the different types of GMP documentation in the pharmaceutical industry, essential for maintaining quality, compliance, and safety in manufacturing...
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EDQM Publishes Revised Ph. Eur. Water Monographs for Feedback

EDQM Publishes Revised Ph. Eur. Water Monographs for Feedback

EDQM releases updated Ph. Eur. water monographs, including key changes to Water for Injection, Purified Water, and TOC standards. Open...
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