SQA Laboratory Quality Systems Flashcards

What is the primary purpose of instrument qualification in a GLP-compliant laboratory?

Answer: To demonstrate that instruments perform consistently within defined operational parameters

Instrument qualification (IQ, OQ, PQ) ensures laboratory instruments are properly installed, operate as intended, and perform consistently for their intended purpose.

In a laboratory quality system, what does 'out-of-specification' (OOS) mean?

Answer: A test result that falls outside the established acceptance criteria

An OOS result is any analytical result that falls outside the specifications or acceptance criteria established in official compendia or by the manufacturer.

What is the purpose of a reference standard in an analytical laboratory?

Answer: To serve as a benchmark for calibrating instruments or quantifying test samples

Reference standards are highly characterized materials used to calibrate instruments or as comparators when quantifying analytes in test samples.

Which document defines step-by-step instructions for performing a laboratory test method?

Answer: Standard Operating Procedure (SOP)

An SOP provides detailed step-by-step instructions for performing laboratory procedures to ensure consistency and reproducibility among analysts.

What is 'method validation' in the context of a GLP laboratory?

Answer: The process of demonstrating that an analytical method is suitable for its intended purpose

Method validation demonstrates through documented studies that an analytical method consistently measures what it is intended to measure with appropriate accuracy, precision, and specificity.

In a laboratory quality system, what is the purpose of an instrument logbook?

Answer: To record usage, maintenance, calibration, and any anomalies for the instrument

Instrument logbooks provide a complete chronological record of use, maintenance, calibration, repairs, and anomalies for GxP traceability and compliance.