The Commissioning and Qualification Baseline® Guide provides advice and guidance that may be applied to all types of facilities, utilities, and equipment found in the healthcare industry. The Guide has incorporated comments from industry representatives from all areas and disciplines, FDA Field Investigators, and personnel from the FDA's Center for Drug Evaluation and Research (CDER).
To assist companies in transitioning from traditional impact assessment based qualification approaches to ICH Q9 QRM based approaches found in ASTM E2500 and the ISPE FSE Guide, ISPE now includes Appendix 2 from the ISPE Guide: Science- and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment with purchases of the Baseline Guide: Volume 5 – Commissioning and Qualification. The Appendix contains an update for use with the Commissioning and Qualification Impact Assessment Chapter of the Baseline Guide Volume 5 based on the experiences of project teams, and considers the benefits and application of science-based process understanding. With the Appendix, purchasers of the Baseline Guide Volume 5 will gain knowledge about an updated approach to impact assessments.
If you have previously purchased Baseline Guide: Volume 5 -Commissioning and Qualification, expect an email with download instructions to access this new value added Appendix. If you intend to purchase Baseline Guide: Volume 5 – Commissioning and Qualification, the new value added Appendix is now included.
This free document explains the relationship between the following ISPE Guides.
Download Mapping Document (Adobe PDF 284 KB)