ABSTRACT
This chapter discusses regulatory requirement for analytical development and validation. It reviews some useful validation study designs, commonly considered validation, and the corresponding acceptance criteria. The chapter describes statistical methods for analysis of validation data. It introduces a newly proposed method for quality control/assurance of a given quality attribute during the manufacturing process in terms of reliability, repeatability, and reproducibility. Food and Drug Administration (FDA) indicates that the analytical procedure may originate from FDA recognized sources such as a compendial procedure from the United States Pharmacopeia (USP)/National Formulary or a validated procedure submitted that was determined to be acceptable by FDA. In the case of compendial procedures, revalidation may be necessary in the following cases: a submission to the USP of a revised analytical procedure; or the use of an established general procedure with a new product or raw material.
