Technology Transfer: A Practical Guide
Technology Transfer: A Practical Guide
There can be few pharmaceutical companies over the last 15 years that have not undergone the maelstrom of take-overs, mergers, downsizing, centres of excellence or product rationalisation. All these events can, and frequently do, result in product or products being transferred between manufacturing sites. At best it will be a product or product type that the receiving site is familiar with, or at worst, one with which they are totally unfamiliar.
The challenges to effect technology transfer in a timely fashion, within budget and achieving savings that have probably been pre-commirted, at the requisite quality are approximately the same for each aspect. This guide provides a "ready reckoner" of the issues to be considered to achieve these objectives, ensuring that the regulatory issues from both a licensing and inspection
perspective are addressed, and maintaining the organisation's integrity for its products and with its shareholders. In considering the technology transfer process reference is made to the situation within the European Union (EU) in the main; however, where useful guides or proposals are available from other regulatory authorities, notably the FDA, these have been included for completeness.
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