ABSTRACT
The proper application of pharmaceutical process management methods is grounded in the fact that all aspects of process management are interconnected, directly or indirectly, and is most often applied correctly by veteran employees. Methods, according to the Artisan Model, are analogous to the human senses used in the process of creating hand-crafted products. The methods discussed are nearly the same ones that are found in the quality toolbox. The current state of methods used in pharmaceutical processes can be summed up as too much or too little method accuracy and precision at the incorrect control points. The current quality tools, when applied properly, offer precise, accurate, robust and specific control within the relevant range of the process. The technology uses a narrow spectral range of infrared light to analyse samples in their native state. Motorola's declared success fuelled a whole new industry to lead companies down a path that is not practically measurable even when using today's state-of-the-art technology.
