1. Is the process new, or a change to an existing one?
2. Has the request been evaluated by the Regulatory department?
3. Has the request been evaluated by the Environmental Health and Safety Department?
4. Has the request been evaluated to establish Validation Recommendations?
5. Requires Characterization (for new Active Pharmaceutical Ingredient [API]):
6. Experimental number necessary?
7. Requires testing of incoming material?
a. Full
b. Other type
9. Documentation from the Supplier required?
a. Certification of a validated process
b. Letter of reference (updated Drug Master File [DMF])
10. Supplier plant audit necessary?
12. Are there copies of the supplier drawings (current vs. proposed), if components are affected?
13. Is there a comparison of the current and proposed dimensions, if components are affected?
14. Is there a comparison between the current and the proposed process, for manufacturing process changes?
15. Is there a list of finished products impacted, including their respective markets?
16. Pilot batches necessary?
17. Revised component specification?
18. Aseptic Process Evaluation needed?
20. Closure Integrity Studies needed?
21. Identify Impacted Lots
22. Stability Recommendations?
a. Stability requirements?
23. List the Procedures affected by the change?
25. Micro Laboratory Tests/ Chemistry Laboratory Test required?
27. Specification Tests and methods revision needed?
28. Master Batch Record revision needed? (Specify Sections)
29. For Component Changes, is there a Planning Impact Evaluation?
30. Does this Change require an update to Laboratory electronic systems?