This text is written by two leading quality specialists and serves as a quick guide reviewing the basic concepts associated with the transfer of product development between manufacturing sites, often to different parts of the world where cultural and management differences abound. It is a "hot" topic which is brought down to earth, covering key activities, documentation, reporting, and post-transfer reporting for manufacturing professionals.
The purpose of this guide is to offer specific guidance on the key aspects, how such issues should be managed, how to document the outcomes to satisfy both internal and external regulators, and suggestions as to the personnel involved within the process. A checklist is included to act as an aide memoire to ensure coverage of these key steps.
Topics covered include the technology transfer team, key activities such as timelines, regulatory issues, process scope determination, documentation, validation (including process, cleaning, analytical, validation, protocol; as well as packaging issues, stability, reports, and post transfer evaluation).
| ISBN | 1904282148 | | DEWEY edition | DC21 | | ISBN13 | 9781904282143
(What's this?) | | Pages | 50 | | Publisher | Sue Horwood Publishing Limited (SHPL) | | Published in | West Sussex | | Imprint | Sue Horwood Publishing Limited (SHPL) | | Height (mm) | 290 | | Format | Paperback | | Width (mm) | 210 | | Publication date | 14 Aug 2002 | | Spine width (mm) | 3 | | DEWEY | 615.19 | | Academic level | Undergraduate, Postgraduate, Professional / Scholarly |
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Purpose. Scope. The technology transfer team. Technology transfer - key activities: timelines; regulatory issues; determining the process scope - managing change; documentation; validation - process validation, cleaning validation, analytical validation, protocol; packaging issues; stability requirements; training. The technology transfer report: contents; approval process. Post-transfer evaluation. Technology transfer checklist. Sources of information. Related websites.
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