Good Automated Laboratory Practices (GALP) MCQs With Answer

Introduction: Good Automated Laboratory Practices (GALP) are essential for ensuring reliable, reproducible, and compliant laboratory results when using computerized and automated systems in pharmaceutical analysis. This quiz set is designed for M.Pharm students to consolidate concepts such as computerized system validation, data integrity (ALCOA), audit trails, access control, change control, and lifecycle management of laboratory information management systems (LIMS) and instruments. Each question targets practical and regulatory aspects you’ll encounter in real-world lab environments and regulatory inspections. Working through these MCQs will deepen your understanding of how GALP integrates with Good Regulatory Practices to maintain quality, patient safety, and regulatory compliance in pharmaceutical laboratories.

Q1. Which principle best describes the requirement that electronic laboratory data must be attributable, legible, contemporaneous, original, and accurate?

• CSV (Computerized System Validation)
• ALCOA
• CAPA (Corrective and Preventive Action)
• GMP (Good Manufacturing Practice)

Correct Answer: ALCOA

Q2. During computerized system validation (CSV) for a new LIMS, which document defines the specific functions the system must perform from a user perspective?

• Validation Summary Report
• Installation Qualification (IQ)
• User Requirements Specification (URS)
• Standard Operating Procedure (SOP)

Correct Answer: User Requirements Specification (URS)

Q3. Which GALP control ensures that every electronic change to data is recorded with who, when, and what was changed?

• Audit trail
• Batch release signature
• Raw data printout
• Archiving policy

Correct Answer: Audit trail

Q4. Under Good Regulatory Practices, what is the primary purpose of establishing role-based access controls in laboratory systems?

• To reduce network latency
• To restrict user permissions to only necessary functions
• To allow all users to modify archival records
• To automate instrument calibration

Correct Answer: To restrict user permissions to only necessary functions

Q5. Which life-cycle activity explicitly assesses the impact of proposed changes to a validated computerized laboratory system?

• Training
• Change control with risk assessment
• Daily backup
• Archival retrieval testing

Correct Answer: Change control with risk assessment

Q6. Which of the following is a key deliverable of Operational Qualification (OQ) for an automated chromatography system?

• Documented user training records
• Testing that demonstrates system functions perform within specified limits
• Long-term archival strategy
• Supplier audit report

Correct Answer: Testing that demonstrates system functions perform within specified limits

Q7. What is the most appropriate immediate action if an audit trail shows deletion of test results without justification?

• Ignore since deletions are expected
• Initiate an investigation and implement CAPA if required
• Delete the entire dataset to remove inconsistencies
• Archive the system and start a new database

Correct Answer: Initiate an investigation and implement CAPA if required

Q8. In GALP, which attribute ensures that recorded electronic data are preserved in a way that they can be retrieved and reproduced over the required retention period?

• Data availability and integrity
• Instrument calibration
• Preventive maintenance
• Batch reconciliation

Correct Answer: Data availability and integrity

Q9. Which regulatory requirement specifically addresses electronic records and electronic signatures relevant to GALP in many jurisdictions?

• ICH Q10
• 21 CFR Part 11
• Ph. Eur. monograph 2.2
• ISO 9001

Correct Answer: 21 CFR Part 11

Q10. For a validated automated assay, why is periodic re‑qualification or re‑validation necessary?

• To satisfy marketing requirements
• To ensure continued fitness for intended use after changes or time-related drift
• To increase sample throughput
• To enable remote access

Correct Answer: To ensure continued fitness for intended use after changes or time-related drift

Q11. Which control is essential to prevent unauthorized modification of calibration and configuration settings on laboratory instruments?

• Open network access for all users
• Physical and logical access controls with administrative rights restricted
• Removing audit trails to simplify data
• Allowing vendors to directly change settings without documentation

Correct Answer: Physical and logical access controls with administrative rights restricted

Q12. What is the best practice for retaining original electronic raw data generated by automated instruments?

• Store only printed summaries
• Retain original electronic raw data in protected, validated repositories with secure backups
• Export data to spreadsheets and discard originals
• Allow each analyst to keep personal copies without controls

Correct Answer: Retain original electronic raw data in protected, validated repositories with secure backups

Q13. Which of the following is NOT a typical element of Computerized System Validation (CSV) documentation?

• Validation plan
• Functional risk assessment
• User Requirements Specification (URS)
• Marketing brochure for the software

Correct Answer: Marketing brochure for the software

Q14. How should exceptions and electronic record deletions be handled to comply with GALP?

• Silent deletions are acceptable if done by senior staff
• All exceptions and deletions must be justified, documented, and reviewed
• Delete records immediately to conserve storage
• Allow deletions without audit trail if data are backed up

Correct Answer: All exceptions and deletions must be justified, documented, and reviewed

Q15. Which risk-based activity helps prioritize validation and controls for automated laboratory systems?

• Change control without documentation
• Risk assessment focusing on patient safety, product quality, and data integrity
• Extensive testing of irrelevant features
• Random unplanned software upgrades

Correct Answer: Risk assessment focusing on patient safety, product quality, and data integrity

Q16. During an inspection, an auditor asks for evidence that instrument methods are traceable to a validated standard. Which document provides the most direct evidence?

• Method validation report with traceability details
• Employee CVs
• Office supply invoices
• Marketing materials for the instrument vendor

Correct Answer: Method validation report with traceability details

Q17. Which backup strategy aligns with GALP for protecting critical electronic laboratory records?

• No backups, rely on original systems only
• Regular automated backups with offsite copies and tested restore procedures
• Manual copying once a year to a USB drive
• Backup only if there is a system failure

Correct Answer: Regular automated backups with offsite copies and tested restore procedures

Q18. What is the appropriate treatment of obsolete electronic systems that still contain regulated data?

• Delete all data immediately
• Implement retirement plan that preserves, migrates, or archives data with integrity maintained
• Leave systems powered off indefinitely
• Hand over to external parties without documentation

Correct Answer: Implement retirement plan that preserves, migrates, or archives data with integrity maintained

Q19. In GALP, why is training on both technical operation and data integrity principles necessary for laboratory staff using automated systems?

• Only for meeting training quotas
• Because technical skills without understanding data integrity can lead to inadvertent noncompliance
• Training is optional if systems are user-friendly
• To increase system downtime

Correct Answer: Because technical skills without understanding data integrity can lead to inadvertent noncompliance

Q20. Which indicator would most directly suggest a failure in GALP practices during routine monitoring of a laboratory information system?

• Consistent, complete audit trails and timely backups
• Frequent unexplained changes to historical records and missing audit trail entries
• Comprehensive SOPs and recent training records
• Validated backup restores and documented change control

Correct Answer: Frequent unexplained changes to historical records and missing audit trail entries

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