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|
Meet 2016 – 2017 ISPE International Board of Directors
Wednesday, 24 Aug 2016 19.08
Biotechnology Manufacturing – Transforming Healthcare for Millions
Tuesday, 23 Aug 2016 13.08
Future of Pharma Product Development & Production Systems
Monday, 22 Aug 2016 13.08