What does change control mean?
Change control is the process that ensures all requests to change a pharmaceutical product are evaluated, regulated and approved. Change control can be either proactive (planned change introduced in a controlled manner) or reactive (controlling instances of unplanned change).
Why do we need change control in pharma?
Change control procedures are put in place to enable products and services to be changed or improved in a controlled manner. This is done by identifying and/or rectifying any potential risks and monitoring these changes to ensure the product or service hasn’t been negatively affected as a result.
Different types of change
Changes made to a product or service that have been pre-planned, evaluated and validated are called planned changes. These changes will have been through several stages of the change control process before being implemented.
Unplanned change (deviation)
Changes that occur because of unexpected incidents are called unplanned changes or deviations. These changes will require immediate attention as soon as they’re picked up, and organisations should have deviation processes in place to successfully manage these changes and ensure they don’t negatively impact the end product.
Change classification categories
Changes to a product or process are classified based on the severity of their impact. Every change, whether planned or unplanned, falls under one of the following categories:
- Minor change – Typically very small adjustments that affect things like changing some of the text on a product’s packaging, for example.
- Major change – Typically changes that impact a product or service on a much larger scale and require more in-depth analysis before approval to ensure that quality and safety won’t be negatively impacted.
- Critical change – Typically changes that could have a severe impact on all aspects of a product or service, such as modifying key ingredients or switching suppliers. This type of change would require several stages of evaluation and regulatory approval.
Pharma change control process
Key features of change control in pharma include:
- Creating a plan and identifying the steps you wish to take in order to successfully control a planned change (or deal with an unplanned change).
- Securing approval of these changes from the necessary regulatory authority before releasing the changed product to be used.
- Staying up to date with the latest Good Manufacturing Practice (GMP) documents and implementing any changes where necessary.
Pharmaceutical change control jobs
Roles and careers related to pharmaceutical change control include: