ABSTRACT
Although validation of analytical and manufacturing processes has always been important in pharmaceutical quality control, recent emphasis on their documentation by the FDA has resulted in a more careful look at the implementation of validation procedures. The FDA defines process validation as ‘‘… a documented program which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specification and quality attributes’’ [1]. Pharmaceutical process validation consists of well documented, written procedures that define processes which ensure that a specific pharmaceutical technology is capable of and is attaining that which is specified in official or in-house specifications, e.g., a specified precision and accuracy of an assay procedure or the characteristics of a finished pharmaceutical product. Validation can be categorized as either prospective or retrospective. Prospective validation should be applied to new drug entities or formulations in anticipation of the product’s requirements and expected performance. Berry [2,5] and Nash [3] have reviewed the physical-chemical and pharmaceutical aspects of process validation.
