SQA SQA Laboratory Quality Systems 2 — Questions and Answers
Question 1: What does 'traceability' mean in a GLP laboratory environment?
- The ability to link a measurement back to a reference standard through an unbroken chain of comparisons (Correct answer)
- Tracking samples from collection to final disposal
- Following laboratory SOPs consistently for every test
- Maintaining records of all analyst training and qualifications
Correct 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.
Question 2: What is an 'invalidated OOS' result in a pharmaceutical laboratory?
- An OOS result caused by a confirmed laboratory error that can be disregarded with proper documentation (Correct answer)
- A result that was below the method's detection limit
- A result not yet reviewed or approved by a supervisor
- An OOS result generated from a stability study sample
Correct 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.
Question 3: Which method validation parameter measures how close test results are to the true value?
- Accuracy (Correct answer)
- Precision
- Specificity
- Linearity
Correct answer: Accuracy
Accuracy (also called trueness) measures how close an analytical result is to the accepted true or reference value of the analyte.
Question 4: In a GLP laboratory, what is the role of the Study Director?
- To have overall responsibility for the technical conduct and GLP compliance of the study (Correct answer)
- To manage laboratory supplies and equipment procurement
- To review all raw data for transcription errors before archiving
- To communicate study results directly to regulatory agencies
Correct 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.
Question 5: What is the purpose of a control sample in a laboratory quality system?
- To monitor ongoing analytical performance and detect system errors during testing (Correct answer)
- To replace reference standards when they become unavailable
- To calibrate automated liquid handling systems
- To validate sample chain of custody documentation
Correct 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.
Question 6: What is the significance of 'raw data' in a GLP study?
- It is the original unmodified record of laboratory observations legally required to be maintained intact (Correct answer)
- It refers only to electronic data captured from automated instruments
- It is a summary report submitted to the study sponsor
- It includes only data entries that have passed supervisory review
Correct 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.
SQA SQA Laboratory Quality Systems 2
What does 'traceability' mean in a GLP laboratory environment?