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GMP Training – Introduction to Quality Control (QC) by www.gmpsop.com
8.0 References and attachments
Integrity and accuracy of a test method
The accuracy, precision, and selectivity of test methods is critical to the reliability
of test results.
To ensure the integrity and accuracy of a test method, the following pre-
requisites are recommended:
accurate and unambiguous interpretation of the written method
proper training of the analysts on the method
properly calibrated and maintained equipment
in-built performance checks per run
clear instruction on how to prepare samples
Typical sample processing in the laboratory
The QC lab fallows a series of documented steps to test a sample. Each of these
steps is supported by a current and validated test method, a qualified
instrument, a calibrated reference standard and an approved specification.
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