ABSTRACT
It has been more than a decade since the publication of the Food and Drug Administration (FDA) Guidelines on Process Validation (1). The intervening years have seen the creation of a whole industry devoted to educating pharmaceutical scientists in the areas of preparing validation protocols and validation reports. These scientists include the R&D analytical chemist in methods development and stability services, the formulation scientist, the analytical chemist in the quality control laboratory, and the validation specialist. However, guidance has been lacking on methods to use for establishing the ‘‘predetermined specifications’’ crucial to any validation study. We appear to have the format and syntax of the protocols correct, but are still failing to receive passing grades in this all-important area, as measured by the number of FD-483’s and ‘‘Warning Letters’’ issued in the area of process validation.
