GAMP 5 Appendix Changes
Main updates to Appendices in GAMP 5
Management Appendices: All management appendices have been reduced but improved to support the main body.
Development Appendices: All development appendices now contain guidelines to aid regulated companies and their suppliers with amending and enhancing their own procedures.
Operational Appendices: The operational appendices explain the arrangement of each operational appendix and the approach used. Information on the main links between various operational processes is supplier.
The operational appendices have been reorganized and now contain 5 new appendices:
- Handover (Appendix O1)
- Incident Management (Appendix O4)
- Corrective and Preventive Action (Appendix O5)
- Repair Activity (Appendix O7)
- System Administration (Appendix O12)
Looking for more on GAMP, why not call us or click on the navigation bar on the left.
 |
 |
|
|
 |
