ABSTRACT
I. INTRODUCTION Validation has been made a requirement of current good manufacturing practices (CGMPs) for finished Pharmaceuticals in the newly created Subpart L of article 21, Code of Federal Regulations (CFR) 211. Process validation has been defined, in 21CFR 210.3, as establishing, through documented evidence, a high degree of assurance that a specific process (i.e., dispersed systems) will consistently produce a product that meets its predetermined specifications and quality characteristics [1].
