Guide Questions to initiate Specification, Tests and Methods Change Controls/ Stability Change Controls

3.0

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?





