SQA SQA Laboratory Quality Systems 1 — Questions and Answers
Question 1: What is the primary purpose of instrument qualification in a GLP-compliant laboratory?
- To demonstrate that instruments perform consistently within defined operational parameters (Correct answer)
- To reduce instrument maintenance costs over its lifecycle
- To train laboratory technicians on proper instrument use
- To obtain warranties and service contracts from vendors
Correct 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.
Question 2: In a laboratory quality system, what does 'out-of-specification' (OOS) mean?
- A test result that falls outside the established acceptance criteria (Correct answer)
- An instrument that has exceeded its scheduled calibration interval
- A sample that was collected or stored improperly
- A reagent that has passed its expiration date
Correct 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.
Question 3: What is the purpose of a reference standard in an analytical laboratory?
- To serve as a benchmark for calibrating instruments or quantifying test samples (Correct answer)
- To document laboratory procedures and test methods
- To train new analysts on instrument operation
- To validate the laboratory information management system
Correct 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.
Question 4: Which document defines step-by-step instructions for performing a laboratory test method?
- Standard Operating Procedure (SOP) (Correct answer)
- Validation Protocol
- Method Validation Report
- Certificate of Analysis
Correct answer: Standard Operating Procedure (SOP)
An SOP provides detailed step-by-step instructions for performing laboratory procedures to ensure consistency and reproducibility among analysts.
Question 5: What is 'method validation' in the context of a GLP laboratory?
- The process of demonstrating that an analytical method is suitable for its intended purpose (Correct answer)
- Updating a method after a regulatory inspection finding
- Training analysts to use a new laboratory instrument
- Reviewing method SOPs for typographical accuracy
Correct 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.
Question 6: In a laboratory quality system, what is the purpose of an instrument logbook?
- To record usage, maintenance, calibration, and any anomalies for the instrument (Correct answer)
- To store calibration certificates received from the manufacturer
- To list all analysts approved to operate the instrument
- To track reagent lot numbers used with the instrument
Correct 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.
SQA SQA Laboratory Quality Systems 1
What is the primary purpose of instrument qualification in a GLP-compliant laboratory?