SQA SQA Laboratory Quality Systems 2

Question 1

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

Accepted Answer

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

Answer

Tracking samples from collection to final disposal

Answer

Following laboratory SOPs consistently for every test

Answer

Maintaining records of all analyst training and qualifications

Question 2

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

Accepted Answer

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

Answer

A result that was below the method's detection limit

Answer

A result not yet reviewed or approved by a supervisor

Answer

An OOS result generated from a stability study sample

Question 3

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

Accepted Answer

Accuracy

Answer

Precision

Answer

Specificity

Answer

Linearity

Question 4

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

Accepted Answer

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

Answer

To manage laboratory supplies and equipment procurement

Answer

To review all raw data for transcription errors before archiving

Answer

To communicate study results directly to regulatory agencies

Question 5

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

Accepted Answer

To monitor ongoing analytical performance and detect system errors during testing

Answer

To replace reference standards when they become unavailable

Answer

To calibrate automated liquid handling systems

Answer

To validate sample chain of custody documentation

Question 6

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

Accepted Answer

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

Answer

It refers only to electronic data captured from automated instruments

Answer

It is a summary report submitted to the study sponsor

Answer

It includes only data entries that have passed supervisory review