Good Laboratory Practices (GLP) are essential principles that ensure the quality, integrity, and reliability of nonclinical laboratory studies in pharmaceutical research. This concise introduction for B.Pharm students covers GLP general provisions including organization and personnel responsibilities, facilities and equipment requirements, SOPs, documentation and record-keeping, reagent and sample management, data integrity, quality assurance (QA) oversight, calibration and maintenance, audit readiness, deviations and corrective actions, and archival of study records. A solid grasp of GLP prepares you for regulatory inspections, reproducible results, and ethical laboratory conduct during drug development and preclinical testing. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the main purpose of Good Laboratory Practices (GLP)?
- To maximize laboratory output regardless of data quality
- To ensure quality, reliability and integrity of nonclinical study data
- To replace the need for regulatory inspections
- To prioritize speed over documentation
Correct Answer: To ensure quality, reliability and integrity of nonclinical study data
Q2. Which unit is primarily responsible for monitoring compliance with GLP within a test facility?
- Research and Development unit
- Quality Assurance (QA) unit
- Human Resources unit
- Procurement unit
Correct Answer: Quality Assurance (QA) unit
Q3. Which document defines step-by-step methods for routine laboratory operations under GLP?
- Study plan
- Instrument manual
- Standard Operating Procedure (SOP)
- Regulatory approval letter
Correct Answer: Standard Operating Procedure (SOP)
Q4. Under GLP, which of the following is considered primary (raw) data?
- Final summary report only
- Original laboratory notebooks, instrument printouts and electronic records
- Handwritten notes copied into a report without originals
- Marketing brochures
Correct Answer: Original laboratory notebooks, instrument printouts and electronic records
Q5. Which aspect of equipment management is required by GLP?
- Install and never calibrate equipment
- Calibration, maintenance records and appropriate qualification
- Use only brand-new equipment
- Allow any staff to perform calibrations without records
Correct Answer: Calibration, maintenance records and appropriate qualification
Q6. Which of the following best describes “chain of custody” in GLP?
- Process for ordering reagents
- Record of transfer, handling and storage of samples to ensure traceability
- Method for equipment purchase
- Procedure for staff recruitment
Correct Answer: Record of transfer, handling and storage of samples to ensure traceability
Q7. How should deviations from an SOP be handled under GLP?
- Ignore them if results look acceptable
- Record the deviation, investigate root cause and implement corrective actions
- Only report them if an inspector asks
- Erase any evidence of the deviation
Correct Answer: Record the deviation, investigate root cause and implement corrective actions
Q8. Which of the following is an essential element of GLP documentation?
- Vague summaries without dates
- Clear, contemporaneous entries with dates, signatures and version control
- Personal opinions without supporting data
- Unsigned photocopies of records
Correct Answer: Clear, contemporaneous entries with dates, signatures and version control
Q9. What is the recommended retention period for GLP study records generally required by regulators?
- One week
- Varies by regulation but often several years; maintain as specified by local regulations
- Dispose immediately after report submission
- Only keep digital copies without originals
Correct Answer: Varies by regulation but often several years; maintain as specified by local regulations
Q10. Which personnel responsibility is emphasized by GLP?
- Working without training to save time
- Ensuring adequate training, qualifications and job descriptions for assigned tasks
- Allowing anyone to approve study reports
- Delegating QA tasks to untrained interns
Correct Answer: Ensuring adequate training, qualifications and job descriptions for assigned tasks
Q11. Why is equipment validation important in GLP-regulated studies?
- To improve laboratory aesthetics
- To demonstrate that equipment performs as intended and produces reliable data
- To avoid purchasing manuals
- To reduce documentation requirements
Correct Answer: To demonstrate that equipment performs as intended and produces reliable data
Q12. Which of the following best defines “study plan” in GLP?
- Informal email summary of activities
- A formal document outlining objectives, design, methods, and responsibilities for a study
- Marketing plan for the product
- List of staff names without tasks
Correct Answer: A formal document outlining objectives, design, methods, and responsibilities for a study
Q13. Under GLP, how should electronic records be managed?
- Without access controls or audit trails
- With appropriate access controls, backup, audit trails and validation
- Only stored on personal devices
- Printed and destroyed immediately
Correct Answer: With appropriate access controls, backup, audit trails and validation
Q14. What role do audits and inspections play in GLP?
- They are optional and rarely useful
- They verify compliance and identify areas for corrective action and improvement
- They replace the need for SOPs
- They are only for promotional purposes
Correct Answer: They verify compliance and identify areas for corrective action and improvement
Q15. Which term best describes the preservation of data accuracy and completeness in GLP?
- Data obfuscation
- Data integrity
- Data disposal
- Data anonymity
Correct Answer: Data integrity
Q16. How should reagents and chemicals be labeled under GLP?
- With clear identity, concentration, expiry date and hazard information
- Only with the purchase order number
- Labels are optional if staff know the contents
- Using temporary sticky notes that are removed later
Correct Answer: With clear identity, concentration, expiry date and hazard information
Q17. Which practice supports traceability in GLP studies?
- Linking samples, test articles, and results through unique identifiers and records
- Mixing samples without labels
- Replacing records with verbal reports
- Storing all data on a single unlabeled sheet
Correct Answer: Linking samples, test articles, and results through unique identifiers and records
Q18. Who approves the final study report in a GLP environment?
- Any laboratory technician
- Designated responsible scientist(s) and QA review as per facility procedures
- External marketing team
- Supply vendor
Correct Answer: Designated responsible scientist(s) and QA review as per facility procedures
Q19. What should a laboratory do when an out-of-specification (OOS) result is obtained?
- Report it immediately, investigate cause, document corrective actions
- Ignore it and continue the study
- Alter the result to match expectations
- Dispose of the sample without record
Correct Answer: Report it immediately, investigate cause, document corrective actions
Q20. Under GLP, which facility requirement is important to prevent cross-contamination?
- Shared unsegregated storage for all chemicals
- Designated areas for sample storage, proper ventilation and controlled access
- Open-door policy for sample access
- Storing samples on the office desk
Correct Answer: Designated areas for sample storage, proper ventilation and controlled access
Q21. Which of the following is an acceptable way to make corrections in GLP records?
- Erase the original entry and write the new one
- Strike through the error, initial, date and write the correct entry nearby
- Replace the page entirely
- Use white-out to cover mistakes
Correct Answer: Strike through the error, initial, date and write the correct entry nearby
Q22. Which statement about personnel training is true under GLP?
- Training is optional for experienced staff
- Documented initial and ongoing training is required for assigned tasks
- Only QA needs training
- Training records can be verbal confirmations
Correct Answer: Documented initial and ongoing training is required for assigned tasks
Q23. What is the significance of SOP version control in GLP?
- Keeps older obsolete procedures in use
- Ensures the correct and current procedure is used and historical changes are traceable
- Makes procedures harder to follow
- Prevents anyone from updating documents
Correct Answer: Ensures the correct and current procedure is used and historical changes are traceable
Q24. Which activity is NOT consistent with GLP principles?
- Maintaining audit trails for electronic data
- Performing equipment qualification and calibration
- Altering raw data to improve study outcomes
- Documenting deviations and corrective actions
Correct Answer: Altering raw data to improve study outcomes
Q25. Which of the following best describes the role of archives in GLP?
- Temporary storage for redundant copies
- Secure long-term storage of study records to ensure retrieval and integrity
- Public display of confidential data
- Place to discard outdated reports
Correct Answer: Secure long-term storage of study records to ensure retrieval and integrity
Q26. For GLP studies involving animals, what general provision is important?
- There are no special provisions for animal studies
- Animal welfare, ethical approvals, proper housing and trained personnel are required
- Use any animals without records
- Treating animals only as equipment
Correct Answer: Animal welfare, ethical approvals, proper housing and trained personnel are required
Q27. Which record is essential to demonstrate reagent suitability under GLP?
- Vendor advertisement brochure
- Certificate of analysis (CoA), batch records and expiry information
- Personal notes about reagent color
- Receipt without identity or expiration
Correct Answer: Certificate of analysis (CoA), batch records and expiry information
Q28. What is a key characteristic of GLP-compliant reports?
- They are vague to protect proprietary methods
- They are comprehensive, transparent and reproducible with traceable raw data
- They omit methods to save space
- They contain only conclusions without evidence
Correct Answer: They are comprehensive, transparent and reproducible with traceable raw data
Q29. How should corrective and preventive actions (CAPA) be managed in a GLP facility?
- CAPA should be documented, implemented, monitored and verified for effectiveness
- CAPA can be noted informally without follow-up
- Implement CAPA only if requested by staff
- Avoid documenting CAPA to keep records short
Correct Answer: CAPA should be documented, implemented, monitored and verified for effectiveness
Q30. Which of the following best supports reproducibility of experiments under GLP?
- Using undocumented ad-hoc methods
- Detailed SOPs, validated methods, trained personnel and complete records
- Relying solely on memory of procedures
- Changing methods frequently without documentation
Correct Answer: Detailed SOPs, validated methods, trained personnel and complete records
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