Change management in the pharmaceutical industry:  Companies always strive for innovation and continual improvement, and sometimes based on the output of process performance, quality monitoring, and CAPA drive changes in the process or systems. A proper change control process must be in place to effectively initiate a change.

We will discuss change management as per ICH Q10 guidelines – Pharmaceutical Quality System. ICH Q10 provides a comprehensive framework that integrates quality into all aspects of pharmaceutical operations.

A company should have an effective change management system in place. It is important as it ensures continual improvement takes places in a timebound and effective way.

Change management Process:

1. Identify and document the changes based on their impact on product quality and safety.
2. Use Quality risk management to evaluate the proposed changes. These changes must be evaluated in relation to marketing authorization as well as design space.
3. Approval of changes – this should be done by evaluating the changes by expert teams from areas like quality assurance, quality control, regulatory affairs, Production.
4. Implementation: The approved changes must be implemented in a timely and effective manner.
5. After implementation, the imparted changes should be evaluated to confirm the change objectives are met and no negative impact on product quality.
6. Documentation: Changes made should be properly documented. The detailed risk assessments, reasons for change, approval records, implementation plans and their validation results

The change management is an important element of pharmaceutical quality system and other elements include CAPA and Process performance and product quality monitoring systems.

Changes may be planned or unplanned and changes may be major, minor, critical based on their impact on product quality.