As B.Pharm students, mastering records and reports under Good Laboratory Practice (GLP) is essential for ensuring data integrity and regulatory compliance in nonclinical labs. This introduction covers GLP documentation principles—ALCOA+ (attributable, legible, contemporaneous, original, accurate, complete), raw data, SOPs, study plans, final reports, audit trails, calibration and reagent logs, sample traceability, corrections, archiving, and Quality Assurance review. Clear record-keeping and standardized reporting support reproducibility, traceability, and successful audits by regulatory authorities. These MCQs focus on practical scenarios, documentation best practices, and common pitfalls in GLP record management to strengthen your competence in pharmaceutical lab documentation. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. Which principle best summarizes GLP requirements for how laboratory entries should be made?
- Anonymous, delayed, and summarized entries
- Attributable, Legible, Contemporaneous, Original, Accurate
- Optional, Loose, Casual, Reproducible, Archived
- Flexible, Verbal, Deferred, Edited, Shared
Correct Answer: Attributable, Legible, Contemporaneous, Original, Accurate
Q2. What is considered “raw data” in a GLP study?
- Only final summarized tables in the report
- Primary observations, original instrument printouts, and signed worksheets
- Only electronic spreadsheets after formatting
- Verbal notes conveyed during meetings
Correct Answer: Primary observations, original instrument printouts, and signed worksheets
Q3. Which record must be signed and dated in GLP documentation?
- Only the final report
- All entries that create or modify data, including corrections
- Only deviations and audit reports
- Only SOPs when created
Correct Answer: All entries that create or modify data, including corrections
Q4. How should a handwritten correction to a laboratory record be made under GLP?
- Erase the original text and re-write the correct value
- Strike through the entry, write the correction nearby, initial and date it, and provide reason if required
- Use white-out to conceal the mistake and rewrite
- Delete the file and recreate a new clean version
Correct Answer: Strike through the entry, write the correction nearby, initial and date it, and provide reason if required
Q5. What is the primary role of Quality Assurance (QA) in GLP?
- To perform all laboratory experiments
- To independently monitor study compliance, records, and reports
- To approve marketing materials for products
- To write SOPs alone without consultation
Correct Answer: To independently monitor study compliance, records, and reports
Q6. Which element is NOT typically part of a GLP study plan (protocol)?
- Study objectives and design
- Detailed statistical analysis plan
- Personal opinions of QA personnel about staff
- List of responsible personnel and facilities
Correct Answer: Personal opinions of QA personnel about staff
Q7. Under GLP, how long should study records generally be retained?
- 24 hours after study completion
- Only until publication of results
- As specified by regulations or sponsor contract, typically several years
- Until staff turnover occurs
Correct Answer: As specified by regulations or sponsor contract, typically several years
Q8. What is an audit trail in electronic GLP records?
- A decorative element in reports
- An immutable history of who changed data, when, and why
- A verbal log kept by the lab manager
- A backup file stored on a removable drive
Correct Answer: An immutable history of who changed data, when, and why
Q9. Which of the following best describes “traceability” in GLP records?
- Ability to estimate market demand
- Linking results back to original samples, methods, and personnel
- Randomized naming of files to protect identities
- Sharing data publicly without identifiers
Correct Answer: Linking results back to original samples, methods, and personnel
Q10. What should a final GLP study report include?
- Only a list of instruments used
- Study objectives, methods, results, discussion, conclusions, and raw data references
- Only the conclusion sentence
- Personal anecdotes from the lab team
Correct Answer: Study objectives, methods, results, discussion, conclusions, and raw data references
Q11. What is the correct action when a deviation from the protocol occurs?
- Ignore it if results look acceptable
- Document the deviation, investigate cause, assess impact, and report appropriately
- Rewrite the protocol to match the deviation without documentation
- Destroy the affected records to avoid scrutiny
Correct Answer: Document the deviation, investigate cause, assess impact, and report appropriately
Q12. Which records are part of equipment maintenance under GLP?
- Calibration certificates, maintenance logs, and qualification records
- Only the purchase invoice
- Only verbal confirmation of working status
- Personal notes of equipment users without dates
Correct Answer: Calibration certificates, maintenance logs, and qualification records
Q13. In GLP, who is responsible for ensuring procedures are followed in the laboratory?
- Only the QA unit
- The study director and laboratory staff following SOPs, with QA oversight
- Solely the sponsor
- The procurement department
Correct Answer: The study director and laboratory staff following SOPs, with QA oversight
Q14. Which descriptor is part of ALCOA+ beyond the original ALCOA elements?
- Ambiguous
- Accessible
- Complete, Consistent, Enduring, Available
- Ad hoc
Correct Answer: Complete, Consistent, Enduring, Available
Q15. What is the preferred method for preserving paper records long-term under GLP?
- Store in unsecured office drawers
- Controlled environmental storage with access control and cataloguing
- Burn after scanning
- Send home with staff
Correct Answer: Controlled environmental storage with access control and cataloguing
Q16. How should electronic records be validated for GLP compliance?
- No validation is needed for trusted devices
- Through documented system validation demonstrating reliability, integrity, and security
- Only by installing antivirus software
- By backing up data to a local laptop weekly
Correct Answer: Through documented system validation demonstrating reliability, integrity, and security
Q17. What information is critical on a sample label in GLP labs?
- Only the sample color
- Unique ID, content, date, origin, and responsible person
- Manager’s favorite code word
- Only the laboratory address
Correct Answer: Unique ID, content, date, origin, and responsible person
Q18. Which practice undermines data integrity in GLP records?
- Timely recording of observations
- Batch editing of raw data without audit trail or justification
- Documented, justified corrections
- Independent QA review
Correct Answer: Batch editing of raw data without audit trail or justification
Q19. What is the function of SOPs in GLP laboratories?
- Provide standardized, written procedures to ensure consistency and compliance
- Replace the need for training
- Serve only as suggestions with no requirement to follow
- Document only the lab’s budget
Correct Answer: Provide standardized, written procedures to ensure consistency and compliance
Q20. Which statement about electronic signatures in GLP is correct?
- Electronic signatures are never allowed
- They are acceptable if secure, attributable, and compliant with applicable regulations
- Any typed name in a file is sufficient
- They should be shared among staff to save time
Correct Answer: They are acceptable if secure, attributable, and compliant with applicable regulations
Q21. When should QA perform inspections during a GLP study?
- Only at the start and never again
- At planned intervals and critical stages, and as needed for deviations
- Only after the final report is submitted
- Only when requested by management informally
Correct Answer: At planned intervals and critical stages, and as needed for deviations
Q22. Which is an appropriate action for archiving study materials?
- Store folders without indexing in a common room
- Index, label, secure, and preserve materials according to retention policy
- Discard everything once the study is published
- Leave materials at the bench for convenience
Correct Answer: Index, label, secure, and preserve materials according to retention policy
Q23. What should a “record of changes” include when preparing a final GLP report?
- Date of change, description, reason, and initials of person making the change
- Only a summary sentence without details
- Only minor typos corrected silently
- Page numbers changed randomly
Correct Answer: Date of change, description, reason, and initials of person making the change
Q24. Which is true about housekeeping of reagent logs in GLP?
- Reagent logs must record receipt, preparation, lot numbers, expiry, and storage conditions
- Reagents need no documentation if used quickly
- Only the chemical name is required without lot or expiry
- Logs should be kept on personal notebooks only
Correct Answer: Reagent logs must record receipt, preparation, lot numbers, expiry, and storage conditions
Q25. How should confidential sponsor information be handled in GLP records?
- Shared freely with all lab visitors
- Restricted access, documented handling, and appropriate confidentiality measures
- Posted on the lab noticeboard
- Left in unlocked cabinets for convenience
Correct Answer: Restricted access, documented handling, and appropriate confidentiality measures
Q26. What is the significance of metadata in electronic GLP data?
- Metadata is irrelevant and can be ignored
- It provides context such as timestamps, user IDs, and instrument settings critical for traceability
- It only stores backup copies of images
- It is a decorative file header
Correct Answer: It provides context such as timestamps, user IDs, and instrument settings critical for traceability
Q27. Which action demonstrates compliance when destroying obsolete GLP records?
- Destroy without documentation to save time
- Follow documented destruction procedures, maintain logs, and obtain required approvals
- Sell them to third parties
- Throw them in regular trash bins
Correct Answer: Follow documented destruction procedures, maintain logs, and obtain required approvals
Q28. What is the correct approach to training records under GLP?
- No records are necessary for training
- Maintain documented evidence of training, competencies, dates, and content for personnel
- Only verbal confirmation is adequate
- Training records can be anonymous and undated
Correct Answer: Maintain documented evidence of training, competencies, dates, and content for personnel
Q29. In reviewing a raw dataset, QA finds missing timestamps. What is the best practice?
- Ignore the issue if numbers look consistent
- Investigate root cause, document findings, and implement corrective action
- Insert timestamps without documentation
- Delete the dataset and start over
Correct Answer: Investigate root cause, document findings, and implement corrective action
Q30. Which international organization provides widely accepted GLP principles for nonclinical safety studies?
- OECD (Organisation for Economic Co-operation and Development)
- WHO (World Health Organization)
- IMF (International Monetary Fund)
- ISO (International Organization for Standardization) for clinical trials
Correct Answer: OECD (Organisation for Economic Co-operation and Development)
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.
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