By Stanley Nusim
Targeting the 3 most important parts that effectively convey an API to market-process improvement, production, and governmental rules and approval-this reference serves as a step by step consultant to the making plans and transparent figuring out of the majority production of APIs. 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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Extra resources for Active Pharmaceutical Ingredients: Development, Manufacturing, and Regulation (Drugs and the Pharmaceutical Sciences)
6. Absence of highly hazardous materials, reactions, or intermediates. 7. , green chemistry). 40 Rosas 8. Probable cost is appropriate to the product. 9. Fits nicely with existing plant running a related process. The relative priorities of these factors vary widely, as they are seldom all present; neither are they fully independent from each other. For example, directness of synthesis may come at the price of a very expensive reactant, or would require that a very hazardous intermediate be made and perhaps isolated.
The above is a partial list of frequent scale-up issues that arise in bulk drug processing with consequences of lower chemical yields, or worse yet, loss of control over the impurity profile, as well as slower processing, excessive damage to microbial cells and crystalline solids, undesirable particle size distributions and any from a wide range of assorted shortfalls in process performance. Understanding, predicting, and dealing with these issues requires more than a modicum of chemical engineering skills, such as fluid mechanics, mass and heat transport, the use of dimensional analysis tools, and mathematical methods for the simulation of events in a new context.
13 depicts the consolidation phase in the know-how vs. applied effort plane. 4. 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.