as of 2019 - 03 - 18
H.6 WHO guidelines on transfer of technology in pharmaceutical manufacturing (Technical Report Series, No. 961 (2011), Annex 7)
1. Introduction
2. Scope
3. Glossary
4. Organization and management
Project team
5. Production: transfer (processing, packaging and cleaning)
Starting materials
Active pharmaceutical ingredients (API)
Excipients
Information on process and finished pharmaceutical products information
Packaging
Cleaning
Implementation of processing, packaging and cleaning systems
6. Quality control: analytical method transfer
7. Premises and equipment
Premises
Equipment
8. Documentation
9. Qualification and validation
General
References
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