SQA Laboratory Quality Systems Flashcards

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

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

A Laboratory Investigation Report documents the systematic investigation, root cause, and corrective actions for an OOS result, OOT trend, or laboratory deviation.

What does 'specificity' mean in analytical method validation?

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

Specificity is the method's ability to measure the intended analyte without interference from impurities, degradants, excipients, or other matrix components.

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

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

SOP revisions require formal change control, management approval, version control, archival of superseded versions, and documented analyst training before the new version is used.

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

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

Proficiency testing programs send blind samples to laboratories and compare their results to accepted values or peer performance, providing external quality assurance.

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

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

An audit trail is a secure computer-generated record that captures all changes to electronic data including the original value, new value, user ID, date, and reason for change.

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

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

Robustness testing evaluates the method's reliability when small deliberate changes are made to parameters like pH, temperature, or flow rate, revealing which factors require tight control.