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Change Control in the FDA-regulated Industry

Change control is the most critical element in a pharmaceutical or biotech company's quality management system - inadequate change control procedures end up creating a huge risk of non-compliance. The FDA's guidance for Industry clearly reinforces the importance of implementing an effective change control procedures as a critical component in an overall quality system - see "Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations (CGMP)". It's important for FDA-regulated companies to be able to implement a quality system that automates change management and change control procedures and ensures that they are in compliance with GxPs and 21 CFR Part 11.

Initiatives to Change
The process of change is the end result of initiatives aimed at improving quality, increasing yield, reducing costs, cutting waste, streamlining processes etc. It would be very difficult to carefully manage change control in a large company or a fast growing organization without an enterprise-wide change control system One of the most important aspects of change control is to maintain a history of changes for audit trail purposes - a capability better facilitated by such systems.

Essential Requirements of Change Control System
The change control system requires a structured approach towards managing change in an environment focused on continuous improvement. The system must manage the end-to-end change control process including initiating, reviewing, approving, distributing and storing change history. Such a system can provide evidence of compliance to FDA. In addition, the system should also help capture relevant information about the objective, nature and scope of change. The scope of the change control program must also cover a broad set of possibilities including changes to product formulation or design, upgrades to facilities, utilities, equipment and computer systems, manufacturing instructions, SOPs, test methods and specifications, any new raw materials as well as any changes in policy.

Change control allows manufacturers to enable certain changes (those that alter specifications, a critical product attribute or bioavailability) as requiring regulatory filings and prior regulatory approval. Implementation of such change control requests is disabled, unless an authorized person can change the status of their change request to "filing completed or secured approval". In addition, a change control system maintains a history of the lifecycle of all change requests - requester name; reviewer(s) name, date reviewed, approval date and name, implementation date etc. Such information is used by FDA during audits to ensure change control procedures are working well. Hence, the major benefit of a change control implementation is that it facilitates a regulatory environment while supporting change for continuous improvement. As a result, change control ensures that the company continues to comply with cGXP.

It's also imperative that employees are better educated on change control methodology and key compliance requirements. Importantly, the system should be flexible enough to allow change control while responding to emergencies or temporary changes by documenting appropriate change justifications.

A change control system provides checks and balances in the quality system by tracking, reviewing and approving changes to materials (e.g., specification, supplier, or materials handling). The implementation also extends change control to suppliers, so that necessary adjustments to the process can be undertaken before processing components impacted by the changes.

Following these critical steps allows for a robust change control system for the enterprise that can help manufacturers manage change and implement continuous improvement in manufacturing.

Key Benefits of Change Control System
The following are the key benefits in using a change control system:

  • Structured and consistent approach towards managing change
  • Documenting the details of change
  • Routing of change requests to appropriate individuals/team for approvals
  • Documentation of change approvals and implementation
  • Maintenance of change history and easy retrieval of information
  • Tracking changes effectively and providing an audit trail
  • Demonstrate compliance to FDA regulations

Overall, companies can see improved benefits for all their stakeholders including QA/QC managers, regulatory affairs specialists, documentation managers, production specialists, facility managers and engineers, operations/maintenance specialists, compliance auditors and R&D tech transfer managers. The benefits are accrued across the extended enterprise. The system also ensures continued compliance with regulations.