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:

1. Introduction

2. Glossary of Terms

3. Background and Landscape for PACS

4. Key elements of a Pharmaceutical quality system for PAC Management

5. PAC Process Tools to Enhance regulatory flexibility

6. Global lifecycle and PAC management

7. Legacy marketed products and ICH Q12

8. Recommendations for harmonization (categorization of changes)

9. Conclusion

10. References

11. Appendix 1

12. Appendix 2