Page 22 - Introduction QC

GMP Training – Introduction to Quality Control (QC) by www.gmpsop.com

Standard operating procedures provide more detailed
and specific requirements for each of the laboratory
STANDARD quality elements. For example, SOPs describe how to
OPERATING handle a sample, how to conduct an audit, how to
PROCEDURES 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
DOCUMENTS chromatographs, and ancillary records that support
the compliance of the laboratory. Ancillary records
would include calibration reports, training records,
and monitoring of the environment.

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