GMP certification flow :
1. Certification contract signing
2. New factory (workshop) project planing and proposal
3. Custom requirement standards, overall arrangement and design verification
4. Diagram design and review confirmation
5. Project construction, equipment installation and GMP supervision
6. GMP document system establishment
7. GMP Training
8. GMP verification
9. Expert on-site inspection
10. Issuing certification
Certification service :
1.Factory on-site diagnosis, propose rectification suggestion
2. Establish GMP certification group and determine responsibility of each position, set up GMP certification working planing, forming written document.
3. Confirmation of factory decoration, equipment, process pipe installation
4. Factory layout, GMP plane layout; GMP purification system modification, 5 main index (temperature, humidity, static pressure difference, dust particle, CFU), and GMP hardware requirements guidance.
5. Hardware modification, production equipment selection
6. GMP basic knowledge training
7. GMP inspection enforcement regulation training
8. Direct production field management, on-site inspection preparation direction and process verification related contents
9. Quality control system and quality technical document compilation
10. Preparation of software and hardware correction and verification
11. Contact authority to examine product and acceptance.
12. State or province FDA inspection of GMP on-site
