ISPE releases guide to change management systems

31-Mar-2022

Built upon the ICH Q10 Pharmaceutical Quality System (PQS) model, the programme is an industry-led approach

The International Society for Pharmaceutical Engineering (ISPE) has announced the release of its APQ Guide: Change Management System. This guide provides a framework for assessing and advancing change management (CM) system maturity level by evaluating documentation, change/scope identification, change rationale, and more.

The release is the third in the planned four-part series seeking to improve the state of pharmaceutical quality and ensure sustainable compliance. This series, in turn, is part of the organisation’s ‘Advancing Pharmaceutical Quality’ initiative, a programme aimed to assess and improve a company’s quality management maturity.

Built upon the ICH Q10 Pharmaceutical Quality System (PQS) model, the programme is an industry-led approach that seeks to advance pharmaceutical quality beyond the submission of data for harmonised, reportable metrics. It’s aligned with international initiatives to promote quality, as well as with the FDA’s interest in quality management maturity and rating the maturity of manufacturing facilities, as cited in its 2019 Drug Shortages report.

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“Pharmaceutical companies are required to have a change management system in place, but an inadequate one may result in ineffective changes that require rework or missed opportunities,” said Guide Lead Lori Chelemedos, Founder/Principal Consultant Pac-Side LLC. “This guide focuses on how to evaluate and optimise the system a company has, provides tools that can be used to improve the system, and offers guidance on how to improve and develop a change management system that is appropriate to a company’s maturity level.”

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