Technical Report No. 91 Post-Approval Change Management
- Published
- Sep 2023
- ISBN
- 978-1-945584-41-1
- Pages
- 70
- PDA Item Number
- 43567
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- Format
- PDF Single User
- Member Price
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- Nonmember Price
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This technical report expands on the latest concepts and
tools for improving PAC management, as published in ICH Q12. It provides a
practical guide for the pharmaceutical industry on how to implement PACs within
the framework of an effective pharmaceutical quality system (PQS) and in
alignment with ICH quality guidelines. It recognizes the challenges that the
limited amount of global harmonization among regulators presents with respect to
PACs and attempts to provide some insight on how industry can work with
regulators to improve in this area. Though TR-91 aligns with ICH Q12, it also
provides guidance for non-ICH regions. It suggests how to implement the tools
described in ICH Q12 and provides examples of the concepts that can facilitate
aligned industry understanding for PACs.
Table of Contents
Table of Contents:
- Introduction
- Glossary of Terms
- Background and Landscape for PACS
- Key elements of a Pharmaceutical quality system for PAC Management
- PAC Process Tools to Enhance regulatory flexibility
- Global lifecycle and PAC management
- Legacy marketed products and ICH Q12
- Recommendations for harmonization (categorization of changes)
- Conclusion
- References
- Appendix 1
- Appendix 2
About the Authors