K-Patents PR-23 for K-Patents Appendix - Manual (Page 45)

Onsite Qualification Protocols and Records: Operational Qualification
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7.5 System qualification
Check that the system is the same as defined in the IQ, with no changes.
Definition of requirements
All system equipment remains the same as for the IQ and the ancillary equipment IQ is valid.
Date Signature Pass Conditional Pass Fail
Conditional pass:
7.6 Setting up the system components and devices
Description of requirements
The Pharma Refractometer system comprised of Refractometer sensor, Pharma mini flow
cell and Indicating transmitter, is assembled and mounted correctly as described in the
Section 3 (this document). Initial startup checks for the Refractometer have been made
according to PROCESS REFRACTOMETER PR-23 INSTRUCTION MANUAL,
Section 5.
Also the ancillary fractionation unit and the sample delivery system (if required) are
connected and the ancillary equipment is switched on and functional checks are made in
accordance with the corresponding operating manuals.
Requirement acceptance values
The system and devices are complete and have been set up in compliance with
the instructions.
Failure to meet any of the acceptance values
Terminate the OQ.
Date Signature Pass Conditional Pass Fail
Conditional pass: