SQA Laboratory Quality Systems Flashcards

What does 'traceability' mean in a GLP laboratory environment?

Answer: The ability to link a measurement back to a reference standard through an unbroken chain of comparisons

Metrological traceability means measurements can be related to a reference through a documented unbroken chain of calibrations, ensuring measurement accuracy.

What is an 'invalidated OOS' result in a pharmaceutical laboratory?

Answer: An OOS result caused by a confirmed laboratory error that can be disregarded with proper documentation

An invalidated OOS is one where a root cause of laboratory error (not product failure) has been scientifically confirmed, allowing the result to be excluded from batch disposition.

Which method validation parameter measures how close test results are to the true value?

Answer: Accuracy

Accuracy (also called trueness) measures how close an analytical result is to the accepted true or reference value of the analyte.

In a GLP laboratory, what is the role of the Study Director?

Answer: To have overall responsibility for the technical conduct and GLP compliance of the study

Under 21 CFR Part 58, the Study Director is the single point of control responsible for the overall conduct and GLP compliance of a nonclinical study.

What is the purpose of a control sample in a laboratory quality system?

Answer: To monitor ongoing analytical performance and detect system errors during testing

Control samples with known values are analyzed alongside test samples to monitor assay performance and detect drift, bias, or random errors.

What is the significance of 'raw data' in a GLP study?

Answer: It is the original unmodified record of laboratory observations legally required to be maintained intact

GLP regulations define raw data as original records that must be preserved intact and are the foundation for study reconstruction and regulatory audit.