Identify parts of the guidance that may warrant revision. Click Chemistry on the list of links to the left of the page. Format There will be five different breakout session topics to discuss postapproval changes.
Participants can select any three.
All issues relating to sterile drug substances and sterile drug products should be discussed in this breakout session. Goals and Objectives Discuss CDER s proposal for risk-based CMC reviews. Identify appropriate attributes and acceptance criteria for drug substance, drug product, and microbiology which can be used to establish a list of low risk drugs. Identify attributes and acceptance criteria important for establishing the GMP status of manufacturers making the low risk drugs. If you do not have Adobe Acrobat to view the file, please download it from the Adobe website.