ABSTRACT
The Validation Guidelines issued by the FDA in 1987 define process validation as establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes. The development of a product and its manufacturing process and specifications, the design of the validation protocol, and the demonstration (validation) runs of the full-scale manufacturing process requires scientific judgment based on good scientific data. Specifications, such as hardness and particle size, should be established prior to validation of the process; these specifications should be included in the validation protocol. The control of mixing times and physical characteristics of all ingredients is critical to successful validation of all formulations and processes. When a manufacturer files a manufacturing process in an application, the FDA expects that the process will yield a product that is equivalent to the product on which the biostudy or pivotal clinical study was conducted.
