TYPE 3 US DMF: CHECKLIST FOR DOCUMENTS

1. Administrative—letters ( we will provide the draft)

2. General Information on the company (company history ,organization
type/structure, name and designation of key personnel for manufacturing/
quality control , plant layout , site plan, certifications)
3. Brand name and common Name of the product for which DMF has to be filed
4. General-information on the product on which DMF has to be filed
5. Physical structure of the product
6. General-properties such as material of construction, dimensions, appearance
7. List of Major Machineries and Testing Equipment used for manufacturing
(along with Model No and suppliers’ name)
8. List of major starting Materials used for manufacturing (along with suppliers
name and test certificate if available))
9. List of major SOP for manufacturing/quality control
10. Description-of-manufacturing-process-and-process-controls
11. List of constituent materials, specifications, COA, Test Methods
12. In process control during manufacturing
13. Process-validation details
14. Specification for the finished Product
15. Analytical-procedures for the finished Product
16. COA for the three latest batches
17. Container-closure-system for shipping the product
18. Specifications and test methods for container/closures
19. Packaging Configuration
20. Statement on storage conditions, expiry date or retest date if applicable
21. Specimen Label
22. Product Images