Change controls and stability change controls are crucial processes in ensuring product quality and meeting regulatory requirements in various industries. These controls entail making adjustments to testing procedures, stability protocols, and product specifications, which may have an effect on a product’s stability, efficacy, and safety. As a result, having a methodical strategy and precise instructions on how to start and handle these adjustments is crucial. We will talk about the important guide questions in this post that can assist organizations in successfully beginning and executing stability change controls as well as specification, tests, and method change controls. Businesses can maintain product quality, reduce risks, and guarantee compliance by adhering to these guidelines.
1. Is the name of the product / product code numbers identified?
2. Specify if Test Method or Specifications are impacted?
3. Is there a document that lists the proposed changes (current vs. proposed)?
4. Are proposed Changes Clear?
5. Will new Laboratory equipment be needed for the change?
6. Does this Change require an update to Laboratory Electronic Systems?
7. Is there impact on the Stability Protocols?
2. Has the request been evaluated by the Technology department?
a. Does it require validation exercises?
3. Has the request been evaluated by the Regulatory department?
5. Is the Change on a Stability Protocol?
a. Interval
b. Test
6. Is the Change related to the Expiration Date?
7. Is there any impact on:
a. Procedures
b. Specifications
c. Test methods and specifications
8. Does this Change require an update to Laboratory Electronic Systems?
After reading this blog, we hope you can understand the importance of change control and properly use the proposed checklist and improve on it further.
Now that you know this:- hopefully you are in position to answer the Assignment(s)
Have you been involved in any change control activities in your lab? If yes recollect your activities?
Does your lab have proper SOP for the implementation of change control in your lab? If so are there effective?
Do you clearly identify whether proposed changed is Critical/Major/Minor? If yes what is the criteria?
Do you clearly identify whether proposed changes effect the quality of the product? Stability of the product? If so then it is properly captured and its impact properly assessed?