A- GMP
1. General considerations
2. Quality control
3. Sanitation
4. Manufacture of sterile preparations
5. Sterilization
6. Terminal sterilization
7. Aseptic processing and sterilization by filtration 88
8. Personnel
9. Premises
10. Equipment
11. Finishing of sterile products
B- Guidelines on pre-approval inspections
1. General
2. Glossary
3. Objectives
4. Priorities
5. Preparation for the inspection
6. Carrying out the inspection
7. Sample collection and testing
8. Follow-up regulatory/administrative decisions
18(hours)