SQA SQA Laboratory Quality Systems 3

Question 1

What is a Laboratory Investigation Report (LIR) used for in a GxP lab?

Accepted Answer

To document root cause analysis and resolution of an OOS result, OOT trend, or laboratory deviation

Answer

To record routine calibration results for all laboratory instruments

Answer

To summarize annual laboratory performance and productivity metrics

Answer

To obtain approval for implementing a new test method

Question 2

What does 'specificity' mean in analytical method validation?

Accepted Answer

The ability of a method to measure the analyte accurately in the presence of other components

Answer

The smallest amount of analyte that can be reliably detected

Answer

The range over which the method gives a proportional linear response

Answer

The agreement between replicate measurements of the same sample

Question 3

In a GLP laboratory, what must happen when an SOP is revised?

Accepted Answer

The revision must go through change control, be approved, archived, and staff must be trained before the new version is used

Answer

The old SOP can be discarded and the new one used immediately upon completion

Answer

Only the laboratory director needs to sign the revised SOP to make it effective

Answer

The revision must be submitted to the FDA for pre-approval before implementation

Question 4

What is the primary purpose of a laboratory proficiency testing program?

Accepted Answer

To evaluate laboratory performance by comparing results to a reference value or peer laboratories

Answer

To certify laboratory analysts for new analytical techniques

Answer

To validate new analytical instruments before routine use

Answer

To assess the accuracy of supplier certificates of analysis

Question 5

What is an 'audit trail' in a computer-based laboratory system?

Accepted Answer

A secure, time-stamped record of all changes made to electronic data, including who made changes and when

Answer

A printed summary of all analytical results generated during a batch

Answer

A log of system downtime events and scheduled maintenance activities

Answer

A report showing all user login and logout times for the system

Question 6

What does 'robustness' testing during analytical method validation assess?

Accepted Answer

The method's capacity to remain unaffected by small, deliberate variations in method parameters

Answer

The method's ability to detect very low concentrations of the analyte

Answer

The reproducibility of results across multiple independent laboratories

Answer

The method's performance when run on different instrument models