TECHNICAL FILE MAY INCLUDE THE FOLLOWING DOCUMENTS (AS APPROPRIATE)
1. Product description
2. Product classification
3. Life time of the product (shelf life if applicable)
4. Product specification / reference standard (refer note – 1)
5. Material specification
6. Product component and assembly drawings
7. Instruction of use / Label.
8. Process flow chart (brief description of manufacturing process)
9. Inspection procedure & sample test report.
10. Sterilization process validation (where appropriate)
11. EPSP Checklist
12. Undertaking to achieve ISO 13485 / IS 15579 Compliance within 12 months.
13. Copy of repeat orders from Indian Institutions/Overseas clients to demonstrate product acceptance ( waiver in case of new facility may be considered).
14. Layout of Plant
15. Environmental Controls (if applicable)