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.

If you don’t find what you are looking for, try using a different term or contact us.

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...
6 Steps on How to Perform Root Cause Analysis (RCA)

6 Steps on How to Perform Root Cause Analysis (RCA)

Learn the 6 key steps to perform Root Cause Analysis (RCA) in pharmaceutical GMP. Prevent recurrence, improve compliance, and enhance...
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...

Contamination, Cross-Contamination, and Mix-Ups in Pharmaceutical Manufacturing

Contamination, Cross-Contamination, and Mix-Ups in GMP

Differentiate contamination, cross-contamination, and mix-ups in pharma manufacturing. Discover their causes, impacts, and prevention strategies to ensure GMP compliance....
Types of Airlocks Used in the Pharmaceutical Industry

Types of Airlocks Used in the Pharmaceutical Industry

Explore types of airlocks in pharma: Cascade, Bubble, Sink. Learn how they ensure contamination control, cleanroom integrity, and GMP compliance....
Karl Fischer Titration

Karl Fischer Titration: The Gold Standard for Water Content Analysis

Karl Fischer titration essentials - the gold standard for precise water content determination....
FDA Draft Guidance: Considerations for Complying with 21 CFR 211.110

FDA Draft Guidance: Considerations for Complying with 21 CFR 211.110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...
Flow Properties of Powders and Granules in Pharma Industry

Flow Properties of Powders and Granules in Pharma Industry

Explore the flow properties of powders and granules in pharma manufacturing. Learn key factors, metrics, and methods ensuring product consistency...

BECOME A GMP INSIDER

Stay in touch and be the first to get the latest GMP News!