GMP Insiders - Your trusted source for GMP compliance!

Subscribe

GMP Insiders logo
GMP Insiders logo
GMP Insiders logo
Picture of GMP Insiders Expert Team

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.

Author social media channels:

Author's Latest Publications

fda-warning-letter-analysis

FDA Warns Aspen SA Sterile Operations for CGMP Violations in Lab Controls, Aseptic Practices, Data Integrity, and Environmental Monitoring

The FDA has issued a warning letter to Aspen SA Sterile Operations for serious CGMP violations, including failures in lab...
Read more >>
fda-warning-letter-analysis

FDA Warns Linghai ZhanWang for Unsafe Materials, Stability Failures, and Poor Oversight

FDA issues a warning letter to Linghai ZhanWang for failing raw material testing, stability studies, and quality oversight, placing its...
Read more >>
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...
Read more >>
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...
Read more >>
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,...
Read more >>
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...
Read more >>
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...
Read more >>
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...
Read more >>
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...

Read more >>
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....
Read more >>
GMP Insiders LOGO Inverted

BECOME A GMP INSIDER

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