Change Management from an Authorities' Perspective

Excerpt from the GMP Compliance Adviser, Chapter 1.D Change Management

5 min. reading time | by Dr. Michael Hiob
Published in LOGFILE 17/2025

What are the important aspects of effective change management from an authorities' point of view?

Dr. Michael Hiob gives an overview on the relevant topics to observe when implementing changes in drug manufacturing. A detailed discussion of the change management procedure can be found in the chapter ‘Change Management’ of the GMP Compliance Adviser.

What topics does change management deal with?

Change management is a central component of the Quality Management System in the pharmaceutical industry. It deals with the systematic handling of changes that may occur during the life cycle of a product. Changes are modifications, variations, redefinitions or deletions of GMP-relevant requirements. The aim is to ensure that all changes to processes, products or documentation are documented, evaluated and approved to guarantee the quality and safety of the medicinal products.

In which areas should change management be applied and who is responsible for implementation?

The change management concept must extend to all GMP-regulated areas. Changes to manufacturing authorisations can trigger changes in the GMP area and vice versa. This interdependence must be considered for every change procedure.

Responsibility for change management is not assigned to a specific function holder. Rather, change management is a cross-sectional task involving all those affected by the change. Change procedures should only be planned, implemented, monitored and tracked by people who are familiar with the subject of the change in question. The expertise of the personnel supervising the processes is invaluable, especially concerning the risk assessment and impact assessment of a change.

What are the basic requirements to observe?

Change management must be handled in an interdisciplinary, prospective and risk-based manner and is linked to the lifecycle of the product.

• An interdisciplinary approach ensures that all aspects of a change are thoroughly evaluated, documented and implemented.
• The prospective approach means that changes are planned and assessed with foresight. Procedural instructions must ensure that certain processes and decision-making stages are executed before a change is implemented.
• Manufacturers must control critical aspects of their work procedures over the entire life cycle of the product and process. This includes the concept of change management and the associated Quality Risk Management. The manufacturer implementing a change must be able to prove that he has assessed the associated risks and is able to control them.

What legislation applies to change management?

The legal basis for change management can be found in EU Directive 2001/83/EC and in local legislation such as the German Medicinal Products Act. Requirements on the handling of changes are also to be found in the EU GMP guidelines, particularly in Annex 15 Qualification and Validation. There are several guidelines from the PIC/S and ZLG on the implementation of change management.

What framework conditions are required to enable effective change management?

Effective change management necessitates various framework conditions. This includes being anchored in the company’s quality policy as well as the clear definition of processes, responsibilities and decision-making authority. The resources required for change management must be provided by senior management.

Robust knowledge management is essential to be able to assess changes prospectively and risk-based and implement them efficiently. However, change management not only affects internal processes, but must also be regulated in contract manufacturing relationships. Last but not least, it is important to simplify the change process, avoid points of friction and reduce costs through effective cooperation with the relevant authorities.

How does a change procedure work in detail?

Every change control begins with a trigger, which can be of an internal, external or regulatory nature. The intended change must be described and justified in the change request. The impact of the change is assessed based on the risks. As part of the risk control process, a decision is then made to approve, reject or cancel the change control procedure. Changes may only be implemented after approval has been granted. Additional requirements may have to be met and/or documents adapted. A separate project organisation may also be required for broad scoped changes. Once the change has been implemented, it must be checked whether the intended effectiveness is also achieved. Depending on the type of change, this can be carried out as part of the management review or PQR, for example, or tracked as part of ongoing process verification and deviation management.

How should change management be documented?

The documentation of change management is not limited to the documentation of individual cases. Change management must be anchored in the quality policy and the validation master plan and described in standard operating procedures. In addition, all raw and summary data used in connection with a change must be fully recorded and stored. There are no specific regulatory requirements placed on archiving operating procedures and change control forms. The retention period depends, among others, on the subject of the change.

How is change management audited?

Auditing change management systems is a critical process to ensure that changes comply with EU GMP Guidelines. Contractor and supplier audits and internal audits (self inspections) are critical to maintaining product quality and compliance with regulatory requirements. These inspections should be carried out at regular intervals or following identification of irregularities.

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