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-warning-letter-analysis

FDA Warning Letter Analysis: Chem-Tech, Ltd. – Deficiencies in OOS Investigation, Cleaning Validation and More

FDA issues a warning letter to Chem-Tech, Ltd. for improper OOS investigations, unvalidated cleaning procedures, and poor quality oversight. Key...
USP-NF Pharmacopeial Forum 51 - Draft proposals

USP–NF Proposed Drafts in PF 51(2): Key Highlights and Industry Impact

Discover the key updates in USP–NF PF 51(2), including revisions to chromatography, analytical instrument qualification, microbial contamination control, solubility measurements,...
fda-warning-letter-analysis

FDA Warning Letter: Marshalls Traditional Healthcare CC

CGMP violations identified in the FDA Warning Letter to Marshalls Traditional Healthcare CC, including deficiencies in finished product testing, process...
fda-warning-letter-analysis

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

FDA warns ABR Laboratory LLC for failing to validate test methods and investigate deviations, risking drug safety. Learn key compliance...
fda-warning-letter-analysis

FDA Issues Warning Letter to Strukmyer Medical Highlighting Serious CGMP Deficiencies

On January 30, 2025, the FDA issued a Warning Letter (320-25-37) to Strukmyer LLC dba Strukmyer Medical, following an inspection...

FDA Draft Guidance: Considerations for Complying with 21 CFR 211.110

FDA Draft Guidance: Considerations for Complying with 21 CFR 211.110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...
fda-warning-letter-analysis

FDA Highlights Systemic Issues at Mylan Laboratories in Recent Warning

FDA warns Mylan Laboratories for critical cGMP violations in quality control, data integrity, and governance, urging urgent corrective actions to...
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...
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...
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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