Description

The ISPE Baseline® Guide: Commissioning and Qualification (Second Edition) provides practical guidance on the implementation of a science and risk-based approach for the Commissioning and Qualification (C&Q) of pharmaceutical manufacturing facilities, systems, utilities, and equipment to demonstrate that they are suitable for the intended purpose. The process described in this Guide supports the application of science and risk management approaches, a focus on product and process understanding, and the application of Quality by Design concepts.

This Guide intends to offer a compliant, integrated C&Q approach to making the qualification process efficient and cost-effective. This approach includes a System Risk Assessment process that identifies Critical Aspects and Critical Design Elements. This Guide recognizes industry best practices regarding C&Q and presents concepts that can assist organizations in meeting current regulatory expectations for system qualification.

This Guide discusses key topics that are essential to an integrated C&Q effort, such as:

How to apply Quality Risk Management to C&Q
Best practices for User Requirements Specification, Design Review, Design Qualification, and acceptance and release
Efficient use of a change management process to support C&Q
Good Engineering Practice documentation standards

The intent of this revision to the Guide is to help the pharmaceutical industry simplify and improve the C&Q process by bringing the “best of the best” together into one document. This Guide also combines concepts from regulatory guidances (e.g., from EMA, FDA, ISO). Certain aspects of the C&Q approach described in the previous edition of this Guide are retired and replaced with Quality Risk Management and Good Engineering Practice concepts.

The ISPE Baseline® Guide: Commissioning and Qualification (Second Edition) replaces the following guides:

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