Baseline Guide Volume 5: Commissioning & Qualification

Individual Download

Member Price
$200.00 / €185.00
Non-Member Price
$515.00 / €455.00

Published: March 2001
Pages: 142

Table of Contents

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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).

New Content Added to the Commissioning and Qualification Baseline Guide!

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.

Mapping Document for ISPE Specification and Verification Guides

This free document explains the relationship between the following ISPE Guides.

  • ISPE Baseline Guide, Volume 5: Commissioning and Qualification (Baseline Guide Volume 5)
  • ISPE Guide: Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment (FSE Guide)
  • ISPE Good Practice Guide: Applied Risk Management in Commissioning and Qualification (Applied Risk Management Guide)

Download Mapping Document (Adobe PDF 284 KB)