GMP Insiders - Your trusted source for GMP compliance!

News

January 5, 2025

FDA Draft Guidance: Considerations for Complying with 21 CFR 211.110

FDA's January 2025 draft on 21 CFR 211.110 outlines CGMP measures for batch uniformity, drug integrity, and advanced manufacturing innovation...

December 1, 2024

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 patient safety....

November 17, 2024

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 participant safety....

November 7, 2024

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....

October 21, 2024

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....

September 5, 2024

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 and compliance....

September 23, 2024

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....

GMP Insiders - Your trusted source for GMP compliance!

Subscribe

FDA Draft Guidance: Considerations for Complying with 21 CFR 211.110

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

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

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

Draft EDQM General Chapter 5.38: Quality of Data

FDA Releases Updated Guidance on Controlling Nitrosamine Impurities in Human Drugs

FDA Warning Letter: Marshalls Traditional Healthcare CC

FDA Issues Warning Letter to ABR Laboratory LLC Over Quality Control Failures

FDA Issues Warning Letter to Strukmyer Medical Highlighting Serious CGMP Deficiencies

FDA Highlights Systemic Issues at Mylan Laboratories in Recent Warning

FDA Warning Letter: MedOffice Saglik Endustri Anonim Sirketi

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

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

Contact Info

BECOME A GMP INSIDER