Page 42 - QA and QC

GMP Training – Quality Assurance and Quality Control by www.gmpsop.com

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

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

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