Checkpoints and Judgment Principles for Manufacturer Field Inspection for the Registration of Foods for Special Medical Purpose (For Trial)

Checkpoints and Judgment Principles for Manufacturer Field Inspection for the Registration of Foods for Special Medical Purpose (For Trial)

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Basic Information
  • Translated By:Chemlinked
  • Release Date:Jul 14, 2016
    Implement Date:/
     
  • Pages:105
    Format:Electronic Edition (Adobe PDF)
    Language:EN
  • Created on:Jul 28, 2016
    Last Updated On:Jul 28, 2016
     
Background

This regulation is formulated to specify the requirements and judgement principle for field inspection of FSMP registration prior to the entry into Chinese market.

Contents
1. Qualification of manufacturing enterprises
2. R & D capability
3. R&D materials
4. Establishment of production quality management system
5. Production staff
6. Production condition
7. Production area division
8. Requirements for cleaning work area
9. Production equipment
10. Material procurement system and supplier auditing, confirmation and change
11. Material acceptance
12. Material inspection and release
13. Material storage
14. Production water
15. Production operating instruction
16. Material weighing
17. Material charging and manufacturing
18. Material balance checking
19. Site-clearing
20. Batch production records
21. Stability investigation records
22. Inspection capacity
23. Inspection system
24. Inspection quality management system