Abstract

In the pursuit of adopting a Risk-Based Approach to Commissioning and Qualification, an Engineering Change Management (ECM) Program can be developed to complement a Quality Change Control Program. An ECM program ensures that all non-critical changes within the GMP space and all changes outside the GMP space are documented, tracked, and managed.

An established ECM program is a critical characteristic indicator of an organization’s maturity level, with regards to its ability to determine the degree and pace of its transition into a Risk-Based Approach for Commissioning and Qualification of equipment, facilities, and related systems.

This presentation will provide a practical and detailed road map of how to develop and implement an ECM program in the pharmaceutical manufacturing industry.

In addition, this presentation will explain the differences between a Change Control Record and Change Management Document. The presentation also includes a risk-based strategy to develop pre-assessment requirements and categorization for the proposed Engineering Changes.