K-Patents PR-23 for K-Patents - Manual (Page 55)

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55
10
Routine Operation Phase
After the instrument is qualified, the instrument can be used to measure analytical data. A
Standard Operating Procedure (SOP) has to be written for the new instrument. Operational
instructions, maintenance and calibration should be included in the SOP. It is unnecessary
to copy the complete operation manual into the SOP. Writing simple instructions referencing
the related manual sections is more effective. The particular tasks and the frequency they
should be performed during maintenance should be clearly stated in the maintenance
section. Tests required to verify the instrument, the acceptance criteria and the frequency for
each test should be covered in the calibration section of the SOP.
Definitions of major and minor repairs, which necessitate partial or full system re-qualification,
should be included as well. For example, the replacement of a Teflon pad in the sample
mixer does not require a full re-qualification. Replacement of optical parts (Prism) will warrant
full requalification.
Good system maintenance starts with the users. Proper care, which can be as simple as
a good system rinsing and clean up after use, will reduce the possibility of system failure
during runs and will extend the useful life of the instrument.
Maintain good usage and service records for the instrument for Good Manufacturing
Practice (GMP) purposes. Records of usage allow the users to be alerted to any system or
instrument calibration failure. The user may have to do an impact assessment to determine
whether the failure would have affected the reliability of the results generated by the system.
The service records will also provide useful information about the system, which may
simplify trouble shooting in some instances.
The GMP requirements dictate that the refractometer calibration verification (see Section
3.1) should be performed at suitable intervals in accordance with an established schedule.
Any instrument failing to meet established specifications shall not be used. Each K-Patents
Pharma Refractometer is recommended to have a calibration verification label applied with
the relevant status information for the system, date of the last calibration verification, who
carried out the verification and the scheduled date for the next verification.