Reviewer Interview Questions and Answers

The guidelines for OOS investigation involve thorough documentation, root cause analysis, and corrective actions.

• Thoroughly document all relevant information related to the OOS (Out of Specification) event.

• Perform a comprehensive root cause analysis to identify the underlying reasons for the OOS.

• Implement appropriate corrective actions to prevent recurrence of the OOS.

• Follow established regulatory guidelines and industry best practices during the investigation.

• Ensure proper c...read more

Measures to reduce human error

• Provide adequate training and education

• Implement standard operating procedures

• Use checklists and reminders

• Encourage reporting of errors

• Conduct regular audits and reviews

Laboratory incidences can be categorized as pre-analytical, analytical, and post-analytical. Each category requires a different approach to deal with them.

• Pre-analytical incidents include sample collection errors, mislabeling, and transportation issues. To deal with them, proper training of staff, use of standardized protocols, and regular quality control checks are necessary.

• Analytical incidents involve errors in testing procedures, equipment malfunction, and calibration iss...read more

Data Integrity guidelines ensure accuracy, completeness, consistency, and reliability of data throughout its lifecycle.

• Data should be recorded contemporaneously and accurately.

• Data should be attributable, legible, and original.

• Data should be complete, consistent, and enduring.

• Data should be secure, backed up, and retrievable.

• Data should be reviewed, approved, and audited regularly.

• Examples include ALCOA+ principles, 21 CFR Part 11, and GAMP 5.