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Category: News

The News category provides timely updates on developments that shape GMP compliance across the pharmaceutical industry. It brings together regulatory changes, FDA and EMA communications, inspection findings, warning letters, and product recalls, highlighting how external events influence daily operations.

With clear context and analysis, this section supports proactive decision-making and helps companies remain aligned with global GMP standards.

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FDA's Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices

FDA Transitional Enforcement Guidance for Ethylene Oxide Sterilization Facility Changes for Class III Devices

FDA announces a new policy on ethylene oxide sterilization site changes for Class III devices, ensuring supply chain stability and...
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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...
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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....
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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...
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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....
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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,...
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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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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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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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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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