ICH Q7 FDA Guidance - Its Structure, History, Application and Writer`s Intent 2019 is an event dedicated to the background of all sections of ICH Q7 guidance and key critical section contents.
ICH Q7 FDA Guidance - Its Structure, History, Application and Writer`s Intent 2019 covers topics such as:
- What caused ICH to take action?
- Why was there a need to write API GMP even though Drug Product GMP (21 CFR Part 210 and 211) already existed?
- Who participated and why?
- How was this need address initially and finally?
- KEY Sections
- Identify Sections of Q7
- How to apply Q7
- Important parts of Key Sections
ICH Q7 FDA Guidance - Its Structure, History, Application and Writer`s Intent 2019 intended for:
- Drug intermediates, excipients, developing, or registration of these with FDA.
- Producing, testing, storing or distributing API
- Repacker or Relabelers of API
- Managers, site managers, Production, Quality, Development, Maintenance, Storage/Distribution Management of API Firms.
