Page 45 - Introduction QC

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

is notified, the sample is retained, and a
documented investigation is commenced.

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.

Before commencing any assay, the analyst should
refer to the current version of the test method. The
test method should be available at the worksite.

Samples must be processed through qualified and
calibrated instruments. The analyst should be

aware of the status of the instrument before
conducting the test. In particular, the analyst
should pay attention to the instrument calibration
status. If an instrument is out of calibration, do

not proceed with the test. All laboratory
instruments, upon introduction to the laboratory,
should undergo formal qualification.

Many tests require comparison of the sample to an

official reference standard. The some core should
be taken in preparing the reference standard as is
taken when preparing the sample for test. The
analyst should ensure that only the current

approved reference standard should be used. The
reference standard number must be recorded in
the test record.

In all QC testing laboratories, there will be a set al
published and approved specifications for each

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