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Process performance qualification protocol is a component of process validation: process qualification. This step is vital in maintaining ongoing production quality by recording and having available for review essential conditions, controls, testing, and expected manufacturing outcome of a production process.
Process qualification is the qualification of manufacturing and production processes to confirm they are able to operate at a certain standard during sustained commercial manufacturing. Data covering critical process parameters must be recorded and analyzed to ensure critical quality attributes can be guaranteed throughout production. [ 1 ]
A highly accelerated life test (HALT) is a stress testing methodology for enhancing product reliability in which prototypes are stressed to a much higher degree than expected from actual use in order to identify weaknesses in the design or manufacture of the product. [1]
Tyndallization is a process from the nineteenth century for sterilizing substances, usually food, named after its inventor John Tyndall, that can be used to kill heat-resistant endospores.
Operational qualification (OQ) – Demonstrates that all facets of the process or equipment are operating correctly. Performance qualification (PQ) – Demonstrates that the process or equipment performs as intended in a consistent manner over time. Component qualification (CQ) – is a relatively new term developed in 2005.
An autoclave is a machine used to carry out industrial and scientific processes requiring elevated temperature and pressure in relation to ambient pressure and/or temperature. Autoclaves are used before surgical procedures to perform sterilization and in the chemical industry to cure coatings and vulcanize rubber and for hydrothermal synthesis .
Conformance testing — an element of conformity assessment, and also known as compliance testing, or type testing — is testing or other activities that determine whether a process, product, or service complies with the requirements of a specification, technical standard, contract, or regulation.
Critical quality attributes are evaluated, and critical process parameters taken into account, to confirm product quality. Once the process qualification stage has been successfully accomplished, production can begin. Process Performance Qualification [8] is the second phase of process validation.