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|
Balancing Pre- and Post-Market Control of Health Supplements
Tuesday, 06 Dec 2016 13.12
Biopharmaceutical Manufacturing Process Validation and Quality Risk Management
Monday, 05 Dec 2016 17.12
Know Before You Go: 2016 ISPE Biopharmaceutical Manufacturing Conference
Friday, 02 Dec 2016 17.12