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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Validation Master Plan (VMP) In the Pharmaceutical Industry

Validation Master Plan (VMP) In the Pharmaceutical Industry

Learn how to create a comprehensive Validation Master Plan (VMP) to ensure consistent product quality and regulatory compliance...
Establishment of Expiry Dates for Commercial and In-House Prepared Reagents In QC Labs

Expiry Dates for Commercial and In-House Prepared Reagents In QC Labs

Discover the best practices for establishing and managing expiry dates for commercial and in-house prepared reagents in QC labs....
FDA Issues Warning Letter to LS Promotions INC. for cGMP Violations

FDA Issues Warning Letter to LS Promotions Inc. for cGMP Violations

FDA issues warning to LS Promotions Inc. for significant cGMP violations. Learn about the key deficiencies, recommended CAPA plan, and...

Different Types of GMP Documentation Used In Pharma Industry

Explore the different types of GMP documentation in the pharmaceutical industry, essential for maintaining quality, compliance, and safety in manufacturing...
EDQM Publishes Revised Ph. Eur. Water Monographs for Feedback

EDQM Publishes Revised Ph. Eur. Water Monographs for Feedback

EDQM releases updated Ph. Eur. water monographs, including key changes to Water for Injection, Purified Water, and TOC standards. Open...
Primary vs Secondary Packaging in the Pharma Industry

Primary vs Secondary Packaging in Pharma Industry

Explore the critical role of primary vs secondary packaging in the pharmaceutical industry, highlighting differences, protection, preservation, and regulatory compliance....
FDA Issues Warning Letter to Chinese Medical Device Manufacturer for GMP Violations

FDA Issues Warning Letter to Chinese Medical Device Manufacturer for GMP Violations

FDA issues warning letter to Chinese medical device manufacturer for GMP violations, including CAPA failures, inadequate investigations, poor design validation,...
IQ, OQ and PQ: Importance in GMP

IQ, OQ and PQ: Importance in GMP

Discover the importance of IQ, OQ, and PQ in GMP, ensuring equipment and systems are installed and function correctly to...
FDA Issues Warning Letter Due to cGMP Violations

FDA Issues Warning Letter Due to cGMP Violations

FDA issues warning to for CGMP violations. Addressing insanitary conditions, quality control, lab testing, and component verification....

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