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PV
Process validation
Валидация процесса
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Статьи |
A process is the controlled interaction of components, equipment, environment, software and personnel to produce a product or achieve an acceptable outcome. Pharmaceutical Services Corporation provides the consulting expertise to demonstrate through appropriate testing that the finished product produced by a specified process meets all release requirements for quality. The process validation protocol describes a plan that demonstrates consistency and reliability in processing and confirms that all component, processing and product specifications are appropriate and attainable under ideal and challenged conditions. The Process Validation effort typically occurs after the Installation Qualification (IQ), Operational Qualification (OQ), and (when required) a Performance Qualification (PQ) have been satisfactorily completed. Successful process validation requires thorough process development, identification of controlled and critical parameters and in-process and final product specifications. Typically at a minimum three (3) consecutive lots of product meeting the established quality specifications are necessary for process validation. These three consecutive lots are completed at the boundaries of critical parameters.
