ABSTRACT
Process validation is more complicated than its relatively simple and clear definition implies. "Documented evidence" means that process validation studies are documented in validation reports. These reports contain a validation protocol, study results, and study authorizations and approvals, often involving quality assurance, process development, and manufacturing managers. Some of these documents may appear in full or summarized form in license applications, and all must be available during inspection of facilities by regulatory authorities. "High degree of assurance" implies the use of statistical techniques to draw a general inference from a limited number of experiments. "Specific process" suggests that process validation studies are process-and product-specific. "Consistency" speaks to the need to demonstrate product and process consistency over
time, across scales used in development and manufacturing, and with variations in raw materials and operating variables. "Pre-determined ... attributes" relates that acceptance criteria must be defined in the preapproved validation protocol, which determines when a process or processing step can be considered to be validated.
