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No rescue missions allowed! d. Successful technology transfer—from early planning for manufacture, process, and plant design, process start-up preliminaries and the actual demonstration that the process works in the commercial plant— rests squarely on the process body of knowledge being as complete as needed by the task and organized to effectively impart knowledge to the downstream organization. Process Development 39 e. Regardless of what organizational arrangement might exist, the bulk process development team needs to assume, hopefully in a collaborative understanding, a leadership role as the bringers of the know-how.

I. The scope and approaches to the dossier are largely in hand, if not in text. 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.

Light chemical processing, if at all. Key duties of this area are to crystallize the final compound as the bulk drug (with the desired chemical and physicochemical attributes). Includes filtration, drying, milling, classification, compacting, blending and packaging. Environ ment is distinctly cleaner than most other areas 3. Aseptic finishing area for bulk drugs (includes solids processing). No chemical processing other than salt formation. Includes all of the above finishing area provisions, but largely in an aseptic processing environment for the preparation of sterile bulk drugs.

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