WHO药品生产技术转移指南Annex7.docxVIP

World Health Organization WHO Technical Report Series, No. 961, 2011 Annex 7 WHO guidelines on transfer of technology in pharmaceutical manufacturing Intr o duction Sc o pe Gl o ssary 4. Organ ization and management 5. Pr o duct ion: transfer (process ing, packag ing and clean ing) 6. Qual ity control: analyt ical method transfer 7. Prem ises and equ ipment 8. D o cumentat ion 9. Qual i?cation and val idation References 285 Introduction These guiding principles on transfer of technology are intended to serve as a framework whi ch can be applied i n a ?exi ble manner rather than as s