Page 30 - Introduction QC
P. 30
GMP Training – Introduction to Quality Control (QC) by www.gmpsop.com
The linearity of an analytical procedure is its ability
(within a given range) to obtain test results which are
LINEARITY
directly proportional to the concentration (amount) of
analyte in the sample
The robustness of an analytical procedure is a
measure of its capacity to remain unaffected by
ROBUSTNESS small, but deliberate variations in method
parameters and provides an indication of its
reliability during normal usage
Managing laboratory instruments
One of the pre-requisites for a reliable and validated method is to ensure that
laboratory instruments are themselves properly qualified. For example, they
must be within calibration, properly maintained and serviced and be compatible
with the laboratory environmental conditions.
The following documents are required for each major laboratory instrument:
instrument history files
calibration certificates
vendor manuals and associated drawings
maintenance and calibration programs and schedules
operating procedures, including safety instructions
software verification and security of electronic data
qualification and validation protocols and reports
If instruments are unreliable, then the test methods themselves are unreliable.
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