ABSTRACT
The focus of cleaning validation has, for the most part, been in the finished drug manufacturing segment, since the finished drug product is the product that most directly and immediately touches the patient. However, certain segments of pharmaceutical manufacturing (including segments of finished drug manufacture) have unique challenges because of the nature of the manufacturing or the product use. This chapter covers special issues in cleaning or cleaning validation for several specific industries, including biotechnology, APIs (active pharmaceutical ingredients), manufactured in bulk form contract drug manufacture, clinical trial drug manufacture, and in vitro diagnostic manufacture. Each of these will be discussed below.
