Glossary Terms (Simple List)
-
Process Parameter (PP)
A process variable, process value or process parameter is the current status of a process under control. An example of this would be the temperature of a furnace. (TR54-4)
An input variable or condition of the manufacturing process that can be directly controlled in the process. Typically, these parameters are physical or chemical (e.g., temperature, process time, column flow rate, column wash volume, reagent concentration, or buffer pH). (TR60-3)
-
Process Performance Attribute (or Process Performance Parameter)
An output variable or outcome that cannot be directly controlled but is an indicator that the process performed as expected. (TR60-2)
-
Process Performance Qualification
Documented verification that a system is capable of consistently performing or controlling the activities of the processes it is required to perform or control, according to written and preapproved specifications, while operating in its specified operating environment. (TR01)
-
Process Performance Qualification (PPQ)
The second element of the Process Qualification. It includes a combination of the actual facility, utilities, equipment, and the trained personnel with the commercial manufacturing process, control procedures, and components to produce commercial batches. A successful PPQ will confirm the process design and demonstrate that the commercial manufacturing process performs as expected. Batches prepared are also called Conformance batches or PPQ batches. (TR60) (TR54-5)
Confirming that the manufacturing process, as designed, is capable of reproducible commercial manufacturing. (TR60-2)
The second stage of process qualification. It includes a combination of the actual facility, utilities, equipment, and trained personnel and the commercial manufacturing process, control procedures, and components to produce commercial batches. A successful PPQ will confirm the process design and demonstrate that the commercial manufacturing process performs as expected. Batches prepared are also called conformance batches or PPQ batches. (TR60-3)
-
Process Performance Qualification Protocol
A written plan preapproved by the quality unit that specifies critical steps, controls, and measurements. The process performance qualification protocol states how process performance qualification or other validation studies will be conducted, identifying sampling, assays, specific acceptance criteria, production equipment, and operating ranges. Results obtained for each study described in the protocol should be evaluated in an associated process validation report. (TR60)
-
Process Performance Qualification Report
A report approved by the quality unit that summarizes specific tests performed, compares the test results with the protocol acceptance criteria, and addresses deviations encountered during the study. (TR60)
-
Process Qualification
Documented verification that a system is capable of consistently performing or controlling the activities of the processes it is required to perform or control, according to written and preapproved specifications, while operating in its specified operating environment. (TR3)
Confirming that the manufacturing process as designed is capable of reproducible commercial manufacturing. (TR54) (TR60) (TR54-5)
-
Process Robustness
Ability of a process to tolerate variability of materials and changes of the process and equipment without negative impact on quality. (TR60)
-
Process Simulation (with microbiological growth media)
Method of evaluating an aseptic process using a microbial growth medium employing methods which closely approximate those used for sterile materials. (TR28)
-
Process Simulation (without microbiological growth media)
Method of evaluating an aseptic process employing methods which closely approximate those used for sterile materials using an appropriate material. (TR28)