Page 41 - QA and QC

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

Many test methods require sample preparation
before the test is run. The test method should
describe exactly how the sample is prepared. This

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.

Copyright©www.gmpsop.com. All rights reserved
Unauthorized copying, publishing, transmission and distribution of any part of the content by electronic means are strictly prohibited.
Page 41 of 64