Tag: FDA guidelines

19 Mar

Environmental Monitoring: Testing Facilities for Contamination in Manufacturing

by April Morone 1 Comments

Environmental monitoring is a critical practice in manufacturing to detect and prevent contamination before it affects products. Learn how zone systems, testing methods, and regulations like FDA and EU GMP Annex 1 ensure safety in food, pharma, and cosmetic facilities.

1 Feb

Partial AUC: Advanced Bioequivalence Measurements Explained

by April Morone 8 Comments

Partial AUC is a advanced pharmacokinetic tool used to measure drug exposure during specific time windows, ensuring bioequivalence for complex formulations where traditional metrics fall short. Used by FDA and EMA for extended-release and abuse-deterrent drugs.