ABSTRACT
In this chapter, emphasis will be placed on the validation of solid dosage forms, from the early stages of product development through pilot scale-up and the commercial manufacturing process. The objective is to present an overview and to discuss aspects of validation in terms of pharmaceutical unit operations; that is, those individual technical operations that comprise the various steps involved in product design and evaluation. The focus of the discussion will be on tablets, but consideration will also be given to hard gelatin capsules. The concept of process validation from its beginnings in the early 1970s through the regulatory aspects associated with current good manufacturing practice (CGMP) regulations and the application thereof to various analytical, quality assurance, pilot plant, production, and sterile produce considerations will be discussed elsewhere in this book [1,2].
