WHO药品生产技术转移指南Annex7VIP专享VIP免费

285© World Health OrganizationWHO Technical Report Series, No. 961, 2011Annex 7WHO guidelines on transfer of technology in pharmaceutical manufacturing1. Introduction2. Scope3. Glossary4. Organization and management5. Production: transfer (processing, packaging and cleaning)6. Quality control: analytical method transfer7. Premises and equipment8. Documentation9. Qualifi cation and validationReferences2861 . Introdu ctionThese guiding principles on transfer of technology are intended to serve as a framework which can be applied in a fl exible manner rather than as str ict rigid guidance. Focus has been placed on the quality aspects, in line with WHO’s mandate.1.1 Transfer of processes to an alternat ive site occurs at some stage in the life-cycle of most products, from development, scale-up, manufacturing, production and launch, to the post-approval phase.1.2 Transfer of technology is defi ned as “a logical procedure that controls the transfer of any process together with its documentation and professional expertise between development and manufacture or between manufacture sites”. It is a systemat ic procedure that is followed in order to pass the documented knowledge and exper ience ga ined dur ing development and or commercialization to an appropr iate, responsible and authorized party. Technology transfer embodies both the transfer of documentat ion and the demonstrated ability of the rece iving unit (RU) to effect ively perform the critical elements of the transferred technology, to the satisfaction of all parties and any applicable regulatory bodies.1.3 L iterature searches revealed little information on the subject originating from national or reg ional regulatory b odies. Gu idance on intracompany transfers ...