The change control system is one of the most important components to the pharmaceutical / biotech industry with regards to a quality management system. A change control system provides assessments within a quality system by tracking, reviewing and approving changes to the following so that necessary assessments to the process can occur before the product / process is impacted by the change(s):
Materials (e.g., specifications, suppliers, or materials handling)
The system must manage the end-to-end change control process including initiating, reviewing, approving, distributing and storing change history. Other aspects are advised to be included, such as, requestor name, reviewer(s) name, date reviewed, approval date and implementation date, which are easily captured through an audit trail and why it is essential for having your change control process in electronic enterprise system.
The process of change is the end result of initiatives aimed at protecting the customer, increasing yield, reducing costs, and streamlining processes. It would be very difficult to manage change control without it being housed in an electronic enterprise system. The core undertaking in a change control system is to evaluate potential impacts and any related consequences in terms of product impact (safety, quality, identity, potency, purity) and current Good Manufacturing Practices (cGMP). The qualification / validation status and product / process license, as well as regulatory filings and prior regulatory approval, must be assessed before a change can be implemented.
A couple of key points to keep in mind when developing, implementing and maintaining a change control system. It's imperative that employees are trained on the change control philosophy and core compliance requirements. Importantly, the system should be flexible enough to allow the control of change while providing contingencies to react to emergencies or temporary changes.
Overall, a change control process in an electronic enterprise system benefits all vested parties including QA/QC managers, regulatory affairs, documentation managers, production personnel, facility managers, operations/maintenance personnel, and compliance auditors.