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Technology transfer packages

Qualifying a third party requires that detailed synthesis, analytical, and GMP information are provided to the third party. This is usually passed to the third party in a technology transfer package (see later). Eventually the third party is registered in the NDA as a supplier who has committed to meet an agreed analytical specification. For materials well back in the synthesis and for raw materials, including solvents, one may need no more than basic analytical release information—appearance, identity, purity (sometimes it may be necessary to set limits on specific impurities). [Pg.129]

Pilot plant processes and manufacturing activities include formulation and process development studies, clinical supply manufacture, and technology evaluation, scale-up, and transfer. Packaging for stability and clinical studies may also occur in the pilot plant, but these activities are often performed in separate, well-defined facilities. It is beyond the scope of this article to discuss all of these areas in detail. Since pilot plant construction is often driven by the strategic necessities defined earlier, only these areas are addressed. [Pg.2892]

The transfer package should be presented to the receiving lab in an understandable format a review of this documentation is considered training and is part of the technology transfer. [Pg.436]

The last cycle, from July 2006 to June 2009, follows the key-note technology transfer. The corresponding goals and work packages are to be described in more detail in Chap. 7. Not every subproject of IMPROVE has a transfer phase. There are 6 transfer subprojects which got through the review process of DFG. Another CRC subproject transfers its research results on the basis of other funding. The Collaborative Research Center 476 has been finished in June 2006. The new Transfer Center (TC 61) was established for this fourth cycle. [Pg.68]

Help promote technology transfer so that the recovery of plastic materials keeps pace with new packaging designs and... [Pg.165]

The revival of the pharmaceutical industry of Ethiopia after the boom and crash is largely attributed to policy reforms, investment and manufacturing incentive packages. One important phenomenon that stands out is joint ventures. Through the initiative of joint ventures, a foreclosed factory revived, an old factory was upgraded, new factories were established, and enhanced technology transfer included localization of technical knowledge within Ethiopia. [Pg.73]

While a complete technology package is essential, the transfer of technology can be enhanced by ... [Pg.53]

Adequate time and resources spent preparing the technology package help ensure an efficient and comprehensive transfer of information and knowledge, and therefore, play an important part in carrying out a safe project. [Pg.56]

Most tolls involve the transfer of proprietary information from one party to the other, typically from the client company to the toller. Each party should have maintained a log of transferred documents or software code to make the return of proprietary documents a simple matter. An initial list of the documents should have been referenced in the contract or as part of the technology package. Keeping records of additional documents transferred during the course of the toll will help eliminate confusion at the end of the project. The toller may need to retain documents appropriate for their process safety system needs. [Pg.138]


See other pages where Technology transfer packages is mentioned: [Pg.497]    [Pg.20]    [Pg.396]    [Pg.15]    [Pg.567]    [Pg.143]    [Pg.497]    [Pg.20]    [Pg.396]    [Pg.15]    [Pg.567]    [Pg.143]    [Pg.42]    [Pg.604]    [Pg.210]    [Pg.43]    [Pg.68]    [Pg.241]    [Pg.327]    [Pg.139]    [Pg.327]    [Pg.3717]    [Pg.3725]    [Pg.3]    [Pg.176]    [Pg.331]    [Pg.158]    [Pg.618]    [Pg.727]    [Pg.501]    [Pg.122]    [Pg.755]    [Pg.122]    [Pg.459]    [Pg.345]    [Pg.480]    [Pg.2172]    [Pg.67]    [Pg.598]    [Pg.499]    [Pg.57]    [Pg.294]    [Pg.245]    [Pg.250]   
See also in sourсe #XX -- [ Pg.122 , Pg.142 ]




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