Page 47 - QA and QC
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GMP Training – Quality Assurance and Quality Control by www.gmpsop.com
handle a sample, how to conduct an audit, how to
release a result from the laboratory and how to
manage a complaint. SOPs are generally not specific
to test methods.
Test methods provide specific step-wise direction on
how to properly execute a test procedure in a
TEST METHODS standardized manner. A test method is specific to on
AND analysis and for on instrumental technique such as
SPECIFICATIONS HPLC. Specifications generally accompany test
methods and provide pass/fail criteria and
acceptance criteria for a test method, such as system
suitability or control limits.
Sample and reagent preparation sheets are used to
document the instructions for preparing laboratory
solutions, standards, and working reagents. It is
SAMPLE AND important in a laboratory to provide accurate
REAGENT
PREPARATION instructions and records of these preparations.
SHEETS Usually these sheets are linked to specific test
methods. Equally important are the instructions for
calibrating standard solutions.
Records of testing include laboratory analyst note
books, specific testing sheets, and analytical
printouts, electronic records such as
LABORATORY chromatographs, and ancillary records that support
DOCUMENTS
the compliance of the laboratory. Ancillary records
would include calibration reports, training records,
and monitoring of the environment.
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