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. This may include testing equipment at maximum operating capacity to show quantity demands can be met. Once all processes have been qualified the manufacturer should have a complete understanding of the process design and have a framework in place to routinely monitor operations. Only after process qualification has been completed can the manufacturing process begin production for commercial use. Equally important as qualifying processes and equipment is qualifying software and personnel. A well trained staff and accurate, thorough records helps ensure ongoing protection from process faults and quick recovery from otherwise costly process malfunctions. In many countries qualification measures are also required, especially in the
pharmaceutical manufacturing
Pharmaceutical manufacturing is the process of industrial-scale synthesis of pharmaceutical drugs as part of the pharmaceutical industry. The process of drug manufacturing can be broken down into a series of unit operations, such as milling, gra ...
field.
Process qualification should cover the following aspects of manufacturing:
* Facility
* Utilities
* Equipment
* Personnel
* End-to-end manufacturing
* Control protocols and monitoring software.
Process qualification is the second stage of
process validation Process validation is the analysis of data gathered throughout the design and manufacturing of a product in order to confirm that the process can reliably output products of a determined standard. Regulatory authorities like EMA and FDA have publis ...
.
A vital component of process qualification is
process performance qualification protocol. PPQ protocol is essential in defining and maintaining production standards within an organization.
See also
*
Installation qualification
*
Design qualification
*
Performance qualification
*
Process validation Process validation is the analysis of data gathered throughout the design and manufacturing of a product in order to confirm that the process can reliably output products of a determined standard. Regulatory authorities like EMA and FDA have publis ...
References
External links
{{Commons category, HTML
Drugregulations.org
Formal methods
Enterprise modelling
Business process management