Can I read Stability Testing: ICH & FDA Compliance Guide on EtoBox?
Stability Testing: ICH & FDA Compliance Guide by Phanita Somepalli is a document available to read on EtoBox.
What is Stability Testing: ICH & FDA Compliance Guide about?
This document outlines the proposed syllabus for a two-day course on stability testing regulations and best practices according to ICH/FDA guidelines. The course covers topics such as understanding cGMP requirements for stability testing, developing stability protocols and SOPs, designing bracketing and matrixing strategies, ensuring compliance of stability labs and methods validation, implementing data management systems, preparing CMC submissions and handling out-of-specification results, and preparing fo
- Author
- Phanita Somepalli
- Language
- EN