Checklist for Site Transfer Products

Checklist for Site transfer (Technology Transfer) products includes (but not limited to):

1. Product details like product name, label claim, shelf life, market.
2. Master Formula Card.
3. Master Packaging Card.
4. Manufacturing Batch records.
5. Packaging Batch records.
6. Executed batch records of manufacturing and packing preferably three batches.
7. Specifications (Drug substance, Excipients, Packaging materials.)
8. Product Specification (In-process, Release / Regulatory, Stability specifications).
9. Tool drawings / change part details (as applicable), in case of capsule products, capsule shell shade and composition copy.
10. Finished product trade dress /CPV Trend.
11. Analytical Method Validation Documents.
12. Cleaning Method Validation Documents.
13. Process Validation Protocols and Reports including Packaging validation.
14. Finished Product pack and Artwork Details.
15. Stability Data and trend.
16. Product Development report if available from receiving site / R & D.
17. Risk Assessment Report.
18. Critical Process Parameters and Critical Quality Attributes.
19. Real Hold time data.
20. Product Development history / Annual Product Review (preferably of last two years), product recalls, market complaint or any other negative or positive trends.
21. Current Regulatory status.
22. Finished product sample of minimum three recent batches.
23. Any other supporting document (if any) Product Quality Complaints, OOS/OOT trend, Unplanned Deviation history.

Read also:

• Technology Transfer in Pharmaceutical Industry
• Major Steps of Technology Transfer Activities in Pharmaceutical Industry

Resource Person: Ammar Idries