This guidance represents the FDA's current thinking regarding GMPs for manufacturing APIs under an appropriate system for managing quality as developed by ICH. It is also intended to help ensure that APIs meet the quality and purity characteristics that they purport, or are represented, to possess.
The ICH Q7A mini-handbook is used in association with several ISPE training courses:
Attendees of the training course receive a complimentary copy of this publication.
|Formats||Member Price||Nonmember Price|
|Bound Version||$5 / €5||$5 / €5|
Know Before You Go: Process Validation Conferences
Friday, 21 Oct 2016 12.10
Chairman’s Chatter: Collaboration
Thursday, 20 Oct 2016 14.10
Moving to Single-Use Continuous Manufacturing
Wednesday, 19 Oct 2016 12.10