H WHO Guidelines H WHO Guidelines
as of 2019 - 03 - 18
H.5 WHO good manufacturing practices for sterile pharmaceutical products (Technical Report Series, No. 961 (2011), Annex 6)
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
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
Further reading
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