PDA Technical Glossary

A documented program that provides a high level of scientific assurance that a manufacturing process will reliably produce acceptable product. The proof of validation is obtained through rational experimental design and the evaluation of data, preferably beginning from the process development phase and continuing through the commercial production phase. (TR01) A documented program that provides a high degree of assurance that a specific process, method, or system will consistently produce a result meeting predetermined acceptance criteria. (TR26) (TR57) (TR70) (TR74) Documented testing, performed under highly controlled conditions, which demonstrates that a process consistently produces a result that meets predetermined acceptance a result that meets predetermined acceptance criteria. Used to test processes, methods, and systems for which conditions can be controlled in the real world (i.e., after completion of testing, when the process is in use). Transportation processes can be qualified but not validated; in the real world, it is not possible to exert control over all parameters that could affect the transportation process (e.g., weather, customs, traffic delays, mechanical failures, etc.). (TR58) A documented program that provides a high de­gree of assurance that a specific process, method, or system will consistently produce a result meeting predetermined acceptance criteria. (Note: Vali­dation is a lifecycle program which may include development and qualification activities for one or more elements/systems that form a process.) (TR54-5) A documented program that provides a high degree of assurance that a specific process, method, or system will consistently produce a result meeting pre-determined acceptance criteria (17). (TR60-3)

A documented prospective study intended to demonstrate suitability for the intended use of previously validated methods, specifically for new products and/or processes. (TR57)

A virus used for characterization of viral clearance of the process when the purpose is to characterize the capacity of the manufacturing process to remove and/or inactivate viruses in general, i.e., to characterize the robustness of the purification process. (TR47)

A virus used in process evaluation studies that either is the virus, or of the same species as a virus known to or possible to contaminate the cell substrate or any other reagents or materials used in the production process. (TR47)

Absence of materials that would adulterate a product when inspected with the eyes. (TR70)

See Porosity. (TR45)

The maximum volume that can be processed through a filter area. It is the volumetric capacity of the filter for a given process fluid and generally expressed in L/m2. (TR41) (TR47)