ABSTRACT

IN this closing chapter, an attempt will be made to bring into perspective the desires of the end user for a consistent product lot after lot and the safety of the product for consumption. The importance of this industry is considerable, and its value is difficult to relate to price and efficacy. A review of the terminology and meanings of quality assurance and quality control will be made (frequently known as QA/QC) from the perspective of understanding and appreciating how they apply to this industry and how they may be implemented. An overview of the most important manufacturing practices that are key to delivering a useful and safe ingredient or product will assist members of the industry to fully appreciate the commitment necessary to fulfill customer needs. A small section will be introduced exploring continuous improvement, the ultimate goal of the quality assurance system. Aspects of quality control will be discussed, with the aid of examples, along with reference to some of the difficulties and limitations inherent to this industry, in particular, as it applies to the desire for identity standardization of active components. New analytical tools and methods will be discussed in relation to sophisticated differentiation techniques of the future.