GMP Insiders

Learn how pharmaceutical manufacturers define specification limits for known, unknown, and total impurities in new drug products, ensuring safety and quality compliance with ICH Q3B (R2) guidelines.

Explore the essentials of User Requirement Specification (URS) for successful project execution. Learn to craft effective URS documents.

Discover the essential information about impurities in pharmaceuticals, their types, and how they impact drug quality. Learn about regulatory requirements, testing strategies, and the importance of analytical methods in ensuring…

Explore effective strategies for maintaining clear and comprehensive records with our guide on good documentation practices, ensuring accuracy and reliability.

Learn GMP cleanroom classes A, B, C, D for contamination control in pharmaceuticals. Understand air cleanliness & particle counts for compliance.

Optimize compliance and quality control in the pharmaceutical industry with eQMS (Electronic Quality Management System). Streamline documentation, enhance regulatory adherence, and elevate overall product quality.

Explore the FDA's latest draft guidance for top-notch quality in topical ophthalmic drug products. Stay informed on key considerations for eye care innovations.

Explore global GMP standards with regulatory bodies like FDA, EMA, and WHO. Ensure compliance for pharmaceutical quality and safety worldwide.

Discover the difference between qualification and validation in regulated industries. Ensure compliance with GxP regulations for quality and safety.

Elevate pharmaceutical supply chain integrity with Good Distribution Practice (GDP). Ensure quality, safety, and compliance in every step.