Page 37 - Introduction QC
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GMP Training – Introduction to Quality Control (QC) by www.gmpsop.com
Checking and reviewing records
A critical part of quality control is ensuring the reliability of results.
One way to ensure that the results are error-free is to conduct a second,
independent check of calculations and raw data, by a different analyst or
supervisor.
The following should be checked:
record has been completed to quality control standards
current approved test method and specifications were used
accurate recording or summary of results from chromatograms
calculations are accurate
replicate results are internally consistent
no deviations from approved test method
results reported are consistent with previous trends
Pharmacopoeial monographs provide general conditions for performing test
methods. Pharmacopoeial methods are considered robust that is, they have been
validated in multiple laboratories, but each laboratory will use unique
instrumentation, different analysts and probably prepare samples differently.
This means that pharmacopoeial methods must be verified as suitable for each
laboratory in which they are used: this is a form of validation. Port of the
verification and transfer to the laboratory involves preparing a specific test
method that is validated and used for initial analyst training. It is expected that
companies publish specific in-house methods.
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