as of 2018 - 12 - 03
H.5 WHO good manufacturing practices for sterile pharmaceutical products (Technical Report Series, No. 961 (2011), Annex 6)
Introduction
Table of Content
1. General considerations
2. Quality control
3. Sanitation
4. Manufacture of sterile preparations
Clean room and clean-air device classification
Clean room and clean-air device monitoring
Terminally sterilized products
Aseptic preparation
Processing
5. Sterilization
6. Terminal sterilization
Sterilization by heat
Sterilization by moist heat
Sterilization by dry heat
Sterilization by radiation
Sterilization by gases and fumigants
7. Aseptic processing and sterilization by filtration
8. Isolator technology
9. Blow/fill/seal technology
10. Personnel
11. Premises
12. Equipment
13. Finishing of sterile products
References
Further reading
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