Page 23 - Introduction QC
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GMP Training – Introduction to Quality Control (QC) by www.gmpsop.com
Typical laboratory documentation
The QC laboratory would be expected to have the classes of documents indicated
on the filing cabinet below. These documents would be subject to regulatory
audit.
TYPICAL LABORATORY DOCUMENTATION
Method validation protocols provide documented
evidence that a given test method con and will
consistently generate reliable results.
Validation of an analytical method is the process of
formally establishing that the method will meet the
intended analytical application, e.g. to identify a
PROTOCOLS
specific impurity.
Protocols ore used to formally describe how a test
method is validated. The protocol includes a range of
experiments or tests used to verify the validity of the
method. Some of these tests include precision,
accuracy, linearity, range, selectivity, sensitivity,
ruggedness, robustness, and system suitability.
Calibration records should include the following:
name of the instrument
unique instrument identification
CALIBRATION
limits for calibration - measurement uncertainly
RECORDS
date of calibration
due date for next calibration
details of maintenance. adjustment. or repair (pre
and post calibration)
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