Active pharmaceutical ingredient objective

Chemical Development s primary objective is to provide quality active pharmaceutical ingredients (APIs) for company Therapeutic Team programs, on time... 

Characterization starts once the synthetic route has been selected, although there will be opportunities to modify the route if the changes do not impact the final solid state or impurity profile of the final active pharmaceutical ingredient. The primary objective is to understand, through experimentation, the chemical and physical chemical processes involved in the transformation of raw materials to intermediates and products. The primary outcome is a process definition that includes the order of manufacturing steps, process parameter control methodology, process parameter limits, raw material specification, and diagnostic metrics. 

One remarkable achievement of red biotechnology was that, although costs in drug development exploded, the costs for process development of manufacturing processes for proteins were reduced over time. This should also be the goal for small molecule pharmaceuticals, which represent the majority of active pharmaceutical ingredients (APIs). The sustainable production of affordable pharmaceuticals and health-care products should be a priority for biotechnology These objectives are... 

It should be evident that concurrent validation is especially useful as a QA tool. This approach to validation is useful to QA because it enables QA to set its own objectives as criteria for PV. For example, QA seeks to have every process validated. Most pharmaceutical products contain one or two active ingredients. Process validation is very straightforward for them however, a whole new situation exists for a multivitamin/multimineral product. Innovative techniques are thus needed to achieve adequate validation. 

Of all the new drug applications approved by the FDA between 1989 and 2000, by the estimate of the National Institute for Health Care Management (NIHCM), only one-third contained new active ingredients that could—even by a generous description—be considered innovative. (The pharmaceutical industry challeges the objectivity of the NIHCM, a nonprofit foundation, because it is heavily funded by the insurance industry, which has a natural bias toward low drug prices.)... 

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