Page 31 - Introduction QC
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GMP Training – Introduction to Quality Control (QC) by www.gmpsop.com
Accurate and traceable laboratory records are vital for a number of reasons. They
are used to verify that all test results are accurate, and that no errors have been
made in calculating results at the lime of batch release. They are used in the
event of a complaint or marketplace problem to confirm that the batch under
review was tested reliably. In some cases, this information may also be used
legally to verify that the laboratory did not make any errors.
Laboratory records are also often audited by regulatory agencies during GMP
inspections or investigations. The official must be satisfied that the right results
have been calculated and entered. Without a fully traceable record, this is very
difficult to prove.
Many laboratories use computer systems to process test data because, if properly
validated and secure, this approach can reduce potential errors in calculations.
The computer system cannot safeguard against incorrectly entered data, so
traceable records including initial observations are also needed.
What do the GMP rules say?
US FDA CFR 211
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