The validating packets are offered by the KAMIKA Instruments company as the additional service for customers, who should carry out qualification and validation of the KAMIKA analyzers (according to the requirements of the Good Manufacturing Practise).
According to December 3rd 2002 regulation of Health Ministry in the matter of the Good Manufacturing Practise (Polish Official Gazette #224, item 1882) the below mentioned statements used in the validating packet have the meanings as follows:
| “qualification” | The action providing the proof that each piece of equipment is working correctly and allows to achieve the expected results | |
| “Installation qualification(IQ)” | Documented verification stating that the installations, systems and pieces of equipment, which have been installed or modified, are in conformance with the approved design and the manufacturer’s recommendations | |
| “Operational qualification(OQ)” | Documented verification stating that the installations, systems and pieces of equipment, which have been installed or modified, are functioning in the prescribed operational ranges in accordance with the requirements of the health product manufacturer. | |
| “Performance qualification(PQ)” | Documented verification stating that the installations, systems and pieces of equipment, considered as a whole, are working efficiently and in a repetitive manner in relation to the approved process and product specification | |
| “Design qualification(DQ)” | Documented verification stating that the proposed design of the installation, systems and pieces of equipment is well fitted to the intended target | |
| “validation” | The action intended to achieve a confirmation, in a documented manner and in conformance with rules of the Good Manufacturing Practise, that the procedures, processes, pieces of equipment, materials, operations andsystems lead in reality to the pre-determined results |
The respective documents from the validation packet are composed of ready-to-use forms and detailed records of testing, which confirm that the KAMIKA analyzer fulfils the requirements of the defined stage of the validation process.
The complete qualification of the system’s equipment (EQ) usually consists of the subsequent documentation: design qualification (DQ), system installation and putting into service, installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ).
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