ABSTRACT
The guidelines on general principles of process validation mention three options: prospective process validation, retrospective process validation, and revalidation. In some situations process performance requalification studies may be required prior to undertaking specific revalidation assignments. In most companies, the validation or Chemistry, Manufacturing and Control committee is charged with the responsibility of establishing and operating the complete validation program for the specific manufacturing site. Elements of the validation concept should be incorporated during each of the various stages of the product and process development continuum. In the normal course of events and following a successfully completed preapproval inspection, formal, threebatch process validation is carried out in accordance with the protocol approved during the preapproval inspection. Procedures with respect to establishing change control should be in place before, during, and after the completion of the formal validation program. In addition to the reaction or extraction step, crystallization, milling, and blending unit operations must be subject to qualification and validation.
