Change control in the pharmaceutical industry is a formal, systematic approach to managing all changes and modifications with specific controls and policies. It is a critical component of pharmaceutical quality assurance systems and is used to modify any process or pharmaceutical SOP. The purpose of change control is to ensure that a proposal for a change is properly evaluated, planned, and executed and fully implemented if approved. The change control process is initiated using a change request form, which includes relevant information such as the originator and originating department, existing process, proposed activity/change, risk assessment, and reason for change. Key features of change control include:

• Controlled set of actions: Change control is a controlled set of actions necessary to ensure a change does not negatively impact a products safety, efficacy, quality, or compliance.

• Proactive or reactive: The control may be proactive, as with planned change, or reactive, as a response to mitigate or eliminate the consequences of unplanned change, also known as deviation.

• Automated system: An automated change control system can integrate and streamline the entire change control process, from submission through resolution.

• Wide area of application: Change control is not department-specific, rather the task of the whole company, due to the wide area of application of change control.

To streamline an effective change control process in the pharmaceutical industry, changes should be adequately justified, indicating the shortcomings of the present process, and include the benefits that the proposed change will have on the existing process and the final product. Using an end-to-end EQMS that automates and integrates critical processes will help pharma companies reduce risk and ensure a consistent, efficient approach to the change control process.