Ispe Gpg26-Processval Toc
Ispe Gpg26-Processval Toc
Ispe Gpg26-Processval Toc
Table of Contents
1 Introduction.......................................................................................................................7
1.1 Foundation for the Good Practice Guide...................................................................................................... 8
1.2 Global Acceptance/Authorization.................................................................................................................. 9
1.3 Scope.......................................................................................................................................................... 12
1.4 Purpose....................................................................................................................................................... 12
1.5 Benefits....................................................................................................................................................... 13
7 Contract Manufacturing................................................................................................ 99
7.1 Contract Development, Manufacturing, and Packaging Organizations and License Holder Relationship..... 99
7.2 Maintaining Compliance while Ensuring Flexibility..................................................................................... 99
7.3 Best Practices in Stage 1............................................................................................................................ 99
7.4 Best Practices in Stage 2.......................................................................................................................... 101
7.5 Best Practices in Stage 3.......................................................................................................................... 102
7.6 Stage Gate Processes.............................................................................................................................. 102
7.7 Regulatory Audit Expectations.................................................................................................................. 105
7.8 Contract Development, Manufacturing, and Packaging Organizations – Specialized
versus One Source Models...................................................................................................................... 105
ISPE GPG: Process Validation – TOC ©2019 ISPE. All rights reserved. www.ISPE.org
Page 6 ISPE Good Practice Guide:
Practical Implementation of the Lifecycle Approach to Process Validation
8 Change Management....................................................................................................107
8.1 Change Management Principles............................................................................................................... 107
8.2 Changing Manufacturing Sites.................................................................................................................. 109
ISPE GPG: Process Validation – TOC ©2019 ISPE. All rights reserved. www.ISPE.org