Technology transfer is a systemic process of transferring the manufacturing process or technology and analytical method from one manufacturing site to another site.
It should be a logical and systemic procedure that controls the transfer of any process together with its documentation and professional expertise between development and manufacture or between manufacture sites.
Succesfull technology transfer is important to ensure the robustness of process, method and technology, and also confirm the stable and high quality of the product.
The transfer protocol should list the intended sequential stages of the transfer. The protocol should include:
- objective;
- scope;
- key personnel and their responsibilities;
- a parallel comparison of materials, methods and equipment;
- the transfer stages with documented evidence that each critical stage has been satisfactorily accomplished before the next commences;
- identification of critical control points;
- experimental design and acceptance criteria for analytical methods;
- information on trial production batches, qualification batches and process validation;
- change control for any process deviations encountered;
- assessment of end-product;
- arrangements for keeping retention samples of active ingredients, intermediates and finished products, and information on reference substances where applicable; and
- conclusion, including signed-off approval by project manager.
Checklist for Technology Transfer Activities
1. Raw material specification and MOA (Supplier and/or In-house)
2. Finished Product Specification and MOA
3. Product stability study specification and MOA
4. Product tooling details (Size-shape, Dimension, Embossing, Tablet thickness)
5. Packaging material details (Foil/container type, thickness, width etc.)
6. Analytical method validation/verification method and report
7. Analytical Method transfer protocol
8. Hold time study (approved protocol & report)
9. Annexure and/or approved PDS
10. BMR & BPR
11. Equipment Used during manufacturing(with capacity)
12. API source list
13. Product storage guide
14. Safety Data Sheet (Raw Material & Product)
15. PDR