8 routine operation phase, Routine operation phase – K-Patents PR-23 for K-Patents Appendix User Manual

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After the instrument is qualified, it 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 down 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
re-qualification.

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 cases.

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 on the system, date of the last calibration verification, who
carried out the verification and the scheduled date for the next verification.

Routine Operation Phase