K-Patents PR-23 for K-Patents Appendix - Manual (Page 43)

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43
7
Onsite Qualification Protocols and
Records: Operational Qualification
Operational Qualification (OQ) is documented verification stating that the equipment and
systems, as installed for the first time or after repairs and major incidents, perform as
intended throughout the required operating ranges. The OQ is to ensure that the K-Patents
Pharma refractometer meets predefined specifications, and all system components function
correctly and according to specifications within a specific environment.
7.1 Individual module and system components check
Checking the operation of the refractometer as an individual module, and as a system that
comprises also of the Pharma mini flow cell, the Computer, the Ethernet connection, the
Computer communication software and Ancillary equipment such as fractionation unit.
● Operational check on the Refractometer consists of Refractive index n
D
accuracy,
linearity and short-term repeatability and reproducibility verification tests with Cargille
standard refractive index n
D
liquids.
● In addition to the system components, testing functional challenge, testing the system
software operation, should be conducted.
● Stage by stage operational procedure checking. A pre-determined set of instructions
can be input stage by stage into the system. The system responses are then
compared to the expected outcome of the instructions to determine any problems in
their fulfillment.
● Sign off when successfully completed.
7.2 Installation Qualification has been performed
successfully
Description of Requirement
An Installation Qualification has been performed for the system.
Requirement Acceptance values
The Installation Qualification has been carried out successfully with the required approval.
Date of Installation Qualification:
Performed by:
Do not proceed with the Operational Qualification until a valid Installation Qualification has
been successfully completed and signed off.