Chapter II GOOD MANUFACTURING PRACTICE

United Kingdom

1. 3Conformity with good manufacturing practice
2. 4Compliance with clinical trial authorisation
3. 5Pharmaceutical quality system
4. 6Personnel
5. 7Premises and equipment
6. 8Documentation
7. 9Production
8. 10Quality control
9. 11Retention of samples used for quality control
10. 12Responsibilities of the qualified person
11. 13Outsourced operations
12. 14Complaints, product recall and emergency unblinding
13. 15Self-inspection by the manufacturer
14. 16Advanced therapy investigational medicinal products