Change control is a process used in the pharmaceutical industry to manage and document changes to products, processes, or systems. It’s a proactive approach that helps ensure the safety, quality, and efficacy of pharmaceutical products.
Here are some steps in the change control process:
Initiate a change request
- Document the change request, including the justification, scope, potential risks and benefits, and resources needed
Perform an impact assessment
- Review the proposed change and assess any risks it may create
Approve or reject the change
- Approve the change request plan, reject it, or send it back for modifications
Implement the change
- Create and execute a plan to implement the change across systems, documentation, and processes
Monitor and report
- Monitor the change’s effectiveness and submit documentation of the change to regulatory agencies as required
Change control helps to:
- Prevent unnecessary changes
- Ensure that all changes are well documented
- Avoid disrupting services for no reason
- Identify impacts of change and mitigate potential disruptions
- Ensure that all changes follow systematic processes
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