By Stanley Nusim

This consultant bargains present and well timed discussions of the method improvement cycle, layout engineering, the approval strategy, qc and coverage, and validation, in addition to plant production actions together with fabrics administration, upkeep, and security.

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There is, of course, no suggestion of the work being completed. Far from it, the consolidation stage is intense in a different way that the development stage was. A great deal of the work ahead is filling blanks (few if the prior work has been done well), refining pilot plant procedures and catching up on the documentation that will support the dossier. Also, the final work on the definition and achievement of the bulk attributes needs to be done to support the final work on the dosage form side and the biobatch and stability studies that will follow.

The Technology Transfer Stage Most of the discussion on the nature and scope of the technology transfer activity is presented in Chapter 3. Nevertheless, the following seems pertinent at this point, as it relates to the technology transfer burden that the bulk process development team carries in addition to its duties on the drug development program: a. A finite effort, even if the midst of a very difficult development stage, must be allocated to look ahead 38 Rosas Figure 13 The consolidation stage in the know-how vs.

12. 3. The Consolidation Stage Although it is not infrequent for a significant bulk process ‘‘loose end’’ to remain tenaciously loose until late in the cycle, by and large the development cycle reaches a stage at which the more difficult development work has been done. To wit: a. The chemical synthesis route is fully defined, albeit sources and specifications of starting materials may still be under negotiation or definition. b. The actual process based on the synthesis route is sufficiently defined and sound pilot plant operating procedures exist or are clearly in the offing.

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