Testing facility operations under GLP MCQs With Answer

Introduction

Testing facility operations under GLP (Good Laboratory Practice) ensure reliable, reproducible, and auditable non‑clinical laboratory data essential for drug development. This introduction covers core concepts B.Pharm students must know: GLP principles, quality assurance, SOPs, documentation and record‑keeping, equipment calibration and maintenance, validation, personnel training, sample handling, data integrity (ALCOA+), audits, deviations and CAPA. Understanding facility layout, environmental monitoring, reagent control, and archiving strengthens compliance awareness. These topics link regulatory expectations with daily laboratory practices so students can design, execute and review studies that meet GLP standards. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. Which principle is central to GLP to ensure raw data traceability?

• Good manufacturing practice
• ALCOA (Attributable, Legible, Contemporaneous, Original, Accurate)
• Risk assessment matrix
• Statistical sampling only

Correct Answer: ALCOA (Attributable, Legible, Contemporaneous, Original, Accurate)

Q2. Who is responsible for implementing GLP within a testing facility?

• Regulatory inspector only
• The study director and facility management
• External auditors
• Equipment manufacturers

Correct Answer: The study director and facility management

Q3. Which document describes step‑by‑step laboratory procedures under GLP?

• Batch production record
• Standard Operating Procedure (SOP)
• Marketing authorization
• Clinical protocol

Correct Answer: Standard Operating Procedure (SOP)

Q4. What does IQ/OQ/PQ stand for in equipment qualification?

• Installation, Operational, Performance Qualification
• Inspection, Observation, Performance Quality
• Initial, Ongoing, Periodic Qualification
• Internal, Outside, Primary Qualification

Correct Answer: Installation, Operational, Performance Qualification

Q5. Which practice prevents unauthorized changes to electronic raw data?

• Open spreadsheet sharing
• User access controls and audit trails
• Printing then discarding electronic files
• Saving files only on local desktops

Correct Answer: User access controls and audit trails

Q6. What is the role of Quality Assurance (QA) in a GLP laboratory?

• Performing all analytical testing
• Ensuring compliance through monitoring and audits
• Marketing laboratory services
• Approving budgets only

Correct Answer: Ensuring compliance through monitoring and audits

Q7. Which of the following best describes a deviation in GLP?

• An intentional change to improve results
• An unexpected departure from an SOP or protocol
• A scheduled maintenance activity
• A routine training session

Correct Answer: An unexpected departure from an SOP or protocol

Q8. What is a CAPA in the context of GLP?

• Corrective and Preventive Action
• Calibration and Performance Assessment
• Certified Analytical Performance Audit
• Control of Analytical Process Activities

Correct Answer: Corrective and Preventive Action

Q9. Which record must be retained as GLP raw data?

• Only summarized reports
• Primary observations, instrument printouts and original chromatograms
• Marketing brochures
• Only electronic spreadsheets without backups

Correct Answer: Primary observations, instrument printouts and original chromatograms

Q10. What is the primary purpose of instrument calibration in GLP?

• To reduce operator workload
• To ensure accuracy and reliability of measurements
• To validate marketing claims
• To comply with tax regulations

Correct Answer: To ensure accuracy and reliability of measurements

Q11. How often should personnel training records be updated under GLP?

• Only at hiring
• Regularly and whenever job tasks or SOPs change
• Only before inspections
• Never, training is optional

Correct Answer: Regularly and whenever job tasks or SOPs change

Q12. Which practice supports sample chain of custody?

• Unlabeled storage in a common fridge
• Documented labeling, transfer logs and secure storage
• Verbal instructions only
• Allowing anyone to remove samples freely

Correct Answer: Documented labeling, transfer logs and secure storage

Q13. What is the difference between GLP and GMP?

• GLP covers manufacturing; GMP covers research studies
• GLP applies to non‑clinical laboratory studies; GMP applies to manufacturing of medicinal products
• They are identical programs with different names
• GMP is only for food industry

Correct Answer: GLP applies to non‑clinical laboratory studies; GMP applies to manufacturing of medicinal products

Q14. Which element is essential for data integrity beyond ALCOA?

• ALCOA is sufficient; no other elements
• ALCOA+ including completeness, consistency and longevity
• Only confidentiality matters
• Only speed of data entry

Correct Answer: ALCOA+ including completeness, consistency and longevity

Q15. What should be included in an analytical method validation under GLP?

• Only the SOP title
• Parameters such as accuracy, precision, specificity, linearity and robustness
• Only calibration status of instruments
• Only personnel names

Correct Answer: Parameters such as accuracy, precision, specificity, linearity and robustness

Q16. How are archives handled under GLP?

• Discarded after one month
• Stored securely with index, access controls and retention schedule
• Left on bench tops
• Sent to off‑site trash

Correct Answer: Stored securely with index, access controls and retention schedule

Q17. What is the function of the study director in GLP studies?

• To manufacture products
• To take overall responsibility for the conduct of the study and its interpretation
• To perform only administrative tasks
• To audit unrelated facilities

Correct Answer: To take overall responsibility for the conduct of the study and its interpretation

Q18. Which activity is part of environmental monitoring in a GLP testing facility?

• Testing marketing strategies
• Monitoring temperature, humidity and contamination levels
• Conducting staff interviews
• Measuring sales figures

Correct Answer: Monitoring temperature, humidity and contamination levels

Q19. What is required when reagents are prepared in a GLP lab?

• No labeling is needed
• Labeling with identity, concentration, preparation date and analyst initials
• Keeping reagent recipes secret
• Storing reagents without documentation

Correct Answer: Labeling with identity, concentration, preparation date and analyst initials

Q20. When should a GLP facility perform an internal audit?

• Never, only external bodies audit
• Periodically as part of QA oversight and after major changes or deviations
• Only when products fail stability tests
• Only at the time of facility closure

Correct Answer: Periodically as part of QA oversight and after major changes or deviations

Q21. Which is a correct practice for corrective actions after a deviation?

• Ignore minor deviations
• Investigate root cause, implement corrective and preventive actions, and document outcomes
• Replace the personnel without investigation
• Hide the deviation from QA

Correct Answer: Investigate root cause, implement corrective and preventive actions, and document outcomes

Q22. How should electronic records be backed up under GLP?

• Not necessary if printed reports exist
• Regular, secure backups with validated restore procedures
• Backups only on USB drives kept on benches
• By emailing datasets to personal accounts

Correct Answer: Regular, secure backups with validated restore procedures

Q23. What is the importance of retention samples in GLP testing?

• They are decorative only
• To allow reanalysis if disputes or stability issues arise
• To be discarded immediately
• To be used in staff training experiments

Correct Answer: To allow reanalysis if disputes or stability issues arise

Q24. Which document outlines the objectives and design of a non‑clinical GLP study?

• Study plan or protocol
• Invoice
• Marketing brief
• Employee handbook

Correct Answer: Study plan or protocol

Q25. What is the correct response to an out‑of‑specification (OOS) result?

• Automatically discard the sample
• Investigate, document findings, and perform appropriate follow‑up actions
• Adjust the result to meet limits
• Ignore and proceed

Correct Answer: Investigate, document findings, and perform appropriate follow‑up actions

Q26. Which of the following supports traceability of consumables?

• Batch numbers, supplier certificates and receipt records
• Using unlabelled generic bottles
• Only verbal confirmation of supply
• Discarding supplier documents

Correct Answer: Batch numbers, supplier certificates and receipt records

Q27. For method transfer between labs under GLP, what is essential?

• No documentation is required
• Comparative validation, documented procedures and training
• Only a phone call approval
• Transfer without verifying equipment

Correct Answer: Comparative validation, documented procedures and training

Q28. Which practice improves laboratory safety and compliance in a GLP facility?

• Skipping personal protective equipment
• Regular safety training, risk assessments and proper disposal procedures
• Storing chemicals without labels
• Allowing food in testing areas

Correct Answer: Regular safety training, risk assessments and proper disposal procedures

Q29. What is documented during a calibration event?

• Only the date is noted
• Instrument identity, standard used, results, date and analyst signature
• Only the manufacturer name
• Calibration is never documented

Correct Answer: Instrument identity, standard used, results, date and analyst signature

Q30. Which regulatory concept requires GLP facilities to make records available during inspections?

• Confidentiality only
• Inspections and audit trails for regulatory compliance
• Marketing privilege
• Intellectual property withholding

Correct Answer: Inspections and audit trails for regulatory compliance

G S Sachin

I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.

Mail- Sachin@pharmacyfreak.com