Author: gmpinsiders

Discover the key differences between RP-HPLC and NP-HPLC. Learn how these contrasting chromatography techniques drive effective compound separation and analysis for diverse applications.

Learn how to create a comprehensive Validation Master Plan (VMP) to ensure consistent product quality and regulatory compliance

Discover the best practices for establishing and managing expiry dates for commercial and in-house prepared reagents in QC labs.

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

Explore the different types of GMP documentation in the pharmaceutical industry, essential for maintaining quality, compliance, and safety in manufacturing processes.

EDQM releases updated Ph. Eur. water monographs, including key changes to Water for Injection, Purified Water, and TOC standards. Open for feedback until Sept 30, 2024.

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, including CAPA failures, inadequate investigations, poor design validation, and labeling issues.

Discover the importance of IQ, OQ, and PQ in GMP, ensuring equipment and systems are installed and function correctly to maintain high-quality manufacturing standards.

Ensuring data integrity and governance in GMP: a comprehensive guide to accurate, consistent, and reliable data management practices for pharmaceutical professionals.