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.

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Difference between reference and retention samples

Reference vs Retention Samples: What is the Difference?

Look into the key differences between reference and retention samples in pharma, their roles in GMP, storage rules, and regulatory...
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...
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....

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