New ISPE APQ Guide Helps Companies Improve Change Management Systems

ISPE’s Advancing Pharmaceutical Quality (APQ) program recently launched its latest guide, Change Management System with the objective of helping companies evaluate and optimize their change management system. The APQ program is built on the foundation of ICH Q10.

ICH Q10 [R1] sets a clear expectation that companies required an effective change management system. More specifically, a change management system should assure that changes are phase appropriate, performed in a timely and effective manner, and draft continual improvement.

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. This Guide focuses on how to evaluate and optimize 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.

Lori Rae Chelemedos

Founder/Principal Consultant

Pac-Side LLC

What are the benefits of having an effective Change Management System?

The Change Management System is the mechanism by which continual improvements are made. With a robust system in place, companies will find changes can be made in a timely and effective manner. For example, should a company identify a deviation trend such as a piece of equipment or material that is routinely failing, an appointed change owner can work across functions to evaluate the issue, seek a robust solution, and implement that solution promptly using a structured approach.

What are the negative impacts of having an ineffective Change Management System?

It is a regulatory requirement to have a Change Management System. However, many companies have not required the cross-functional collaboration that is necessary to adequately evaluate and implement change. As a consequence, this lack of stakeholder and customer input frequently results in rework and/or missed change opportunities due to gaps in the design of the change.

What are the signs that a company’s Change Management System is inadequate?

There are various signs that a company’s Change Management System is inadequate and range from the way in which records are managed, to poor solution design, to oversights during implementation. More specifically, the system may need additional attention if the information recorded in a change record does not contain enough information for a reader to understand the issue and resulting activities and design, and/or if records are continually late or aging for a long period of time, the ‘problem’ that the change was intended to solve reappears, or there were identified areas that failed during implementation (e.g., some stakeholders did not receive training, etc.).

Why should someone purchase this Guide?

This Guide will help leaders in the pharmaceutical industry understand the expectations of a Change Management System and help them gauge the health of their company’s current Change Management System. It provides guidance on how to approach improvements and develop a plan that is appropriate to a company’s maturity level and will help them understand how the Change Management System integrates into other areas of the FDA’s Pharmaceutical Quality System and how those areas interact with the Change Management System.

What are some of the key takeaways from this Guide?

It is very important to understand the expectations and opportunities at every Change Management process maturity level and to continually be evaluating the current maturity of a company’s systems and related continual improvement. This Guide will help people in the pharmaceutical industry understand expectations and identify aspects of change management where potentially a company can improve, and provide the tools to improve their change management system.

How does the ISPE APQ Guide: Change Management System differ from The ISPE PQLI® Guide: Part 3 – Change Management System?

The PQLI Change Management guide focuses on what a Change Management System is. The APQ Change Management Guide focuses on how to evaluate and optimize the system that a company has.

About APQ

ISPE’s Advancing Pharmaceutical Quality (APQ) program proposes an industry-led approach to advance pharmaceutical quality beyond the submission of data for harmonized, reportable metrics. The basic framework of the program is to “assess and aspire” quality maturity. The program is aligned with international initiatives that promote quality excellence, as well as with the FDA’s interest in quality management maturity and rating the maturity of manufacturing facilities, as cited in their 2019 Drug Shortages report. The result is a program that organizations can leverage to ensure a continuous supply of quality medicines to patients.

The APQ Guide Series provides a practical set of tools and systematic approaches for organizations to proactively advance the maturity and effectiveness of the following PQS elements:

• Corrective and Preventive Action System
• Management Responsibilities and Management Review
• Change Management System
• Process Performance and Product Quality Monitoring System

The ISPE APQ Guide: Management Responsibilities and Management Review focuses specifically on application of the APQ framework to leadership systems.

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