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Change control guidelines are designed to mitigate the risks associated with product modifications, and strict adherence to these guidelines is important. Identifying the attributes of change should begin early in the development cycle, encompassing the manufacture of products for pre-clinical and clinical testing, as well as throughout the product life cycle. Every change in design or manufacturing processes must be thoroughly documented according to regulatory guidelines.

Typically, the control of changes is overseen by a change control committee or designated individuals, depending on the size and complexity of an organization. All discussions, meeting minutes, emails, and notes associated with changes must be included in change documentation, regardless of the number of people involved. A controlled change is defined by the establishment of all necessary documents, approvals, and data, while uncontrolled changes can lead to compliance violations if not properly reviewed and approved by quality control.

The specific processes involved in change control may vary depending on the organization, but they should include certain minimum requirements. A change request form is completed and submitted, with details such as the description of the change, potential impact on other documents, and dates of approval. The change control staff reviews the request form to assess the significance of the change and its alignment with current good manufacturing practices (CGMP). Once reviewed and approved, the change control staff submits the necessary documentation to the appropriate regulatory authorities.

While change control may seem straightforward for smaller-scale businesses, it becomes more complex as the organization grows and handles additional processes and products. However, there are solutions to streamline document collaboration through enhanced document sharing and meeting software. Storing documents in a centralized digital location with clear revision/change history, such as SharePoint, can reduce the need for additional (or manual) documentation.

When developing or optimizing change control procedures, it is important to consider the regulatory perspective. While there may be regional differences between regulatory agencies such as the FDA, ISO, and the EU, the general principles covered by CGMP guidelines include having written procedures for proposed changes, providing supporting data to demonstrate the quality of revised processes, ensuring all changes are controlled and documented, and recording and justifying any deviations from established control procedures.

For more information on change control procedures as part of ISO 13485 certification for medical devices, reach out to PJR via phone: (248) 358-3388 or email: [email protected].

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