Describe what a "change control" process is in GMP.

The change control process in Good Manufacturing Practice (GMP) is crucial for maintaining product quality and ensuring that any modifications to the manufacturing process, equipment, or materials are thoroughly evaluated and documented. This process helps to prevent unintended consequences that could arise from changes, ensuring that product specifications and compliance to regulatory standards are upheld.

By systematically reviewing and approving changes, the process mitigates risks to both product quality and patient safety. It involves steps such as assessing the potential impact of the change, obtaining necessary approvals, implementing the change in a controlled manner, and verifying that the change achieves the intended outcome without adversely affecting the product.

This rigorous approach allows organizations to respond effectively to new information, operational needs, or improvements while maintaining a high standard of quality in their products.