Page 44 - Introduction QC

GMP Training – Introduction to Quality Control (QC) by www.gmpsop.com

may involve simple dilution or more complex
extraction and manipulation. Always refer to the
current test method before setting up the sample.

Once the sample is prepared, it is included in the
test run. Care must be taken to ensure that the

sample is not degraded, e.g. by spillage, exposure
to atmosphere, or temperature degradation on the
bench. Always refer to the current test method for
instructions and how to protect the sample during
testing. Concurrent with testing the sample,
analysts should ensure that the instrument or a
logbook records the sample number, and it traced
exactly to the test result.

For instrumental runs such as HPLC/GC, the test
method usually includes a verification that the
entire instrumental system is performing
satisfactorily on the day of the run. This is called
"system suitability testing" (SST). Non-
instrumental methods may also include control or
equivalent verification systems. The test methods

should describe how the integrity of particular test
runs is verified.

Once the sample has been run, either the
instrument or the analyst will perform a
calculation to arrive of a result. It is essential to
double check all calculations before finalizing

sample results.

All QC laboratories have written procedures for
handling and investigating only result that
appears to be OOS. The analyst should ensure
that as soon as an OOS event occurs, supervision

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