Documentation requirements in GLP MCQs With Answer

Introduction

Documentation is the backbone of Good Laboratory Practice (GLP) and an essential topic for M. Pharm students preparing for regulatory and quality roles. This blog focuses on documentation requirements in GLP and offers targeted multiple-choice questions with answers to reinforce understanding. You will review principles such as ALCOA(+), proper handling of raw data, SOPs, archiving, electronic records and audit trails, corrections and amendments, signature and authorization practices, chain of custody, deviations and CAPA documentation, and responsibilities for record retention. These MCQs are designed to deepen your practical knowledge, improve exam readiness, and prepare you for real-world compliance challenges in regulated laboratories.

Q1. Which principle best summarizes the requirement that data must be recorded at the time the activity is performed?

• Legibility
• Contemporaneous
• Attributable
• Original

Correct Answer: Contemporaneous

Q2. Which of the following is NOT a core element of ALCOA(+)?

• Attributable
• Legible
• Confidential
• Accurate

Correct Answer: Confidential

Q3. In GLP, the term “raw data” typically refers to:

• Final study report only
• Original records and certified copies from which results are derived
• Summaries prepared for regulatory submission
• Only electronic printouts

Correct Answer: Original records and certified copies from which results are derived

Q4. Which practice is acceptable when correcting a handwritten experimental entry in a GLP lab notebook?

• Obliterate the error with heavy ink and rewrite
• Use correction fluid and initial the change
• Cross out with a single line, add correct entry, initial and date the correction
• Erase and rewrite to keep the entry neat

Correct Answer: Cross out with a single line, add correct entry, initial and date the correction

Q5. Which document should describe the objectives, design, methods and planned analyses of a GLP study?

• Standard Operating Procedure (SOP)
• Study Plan or Protocol
• Final Study Report appendix
• Quality Assurance Audit Report

Correct Answer: Study Plan or Protocol

Q6. What is a critical documentation requirement for an electronic laboratory system used in GLP studies?

• System may be used without validation if backed up daily
• System validation demonstrating it is fit for intended use and reliable
• No documentation needed if paper copies are printed later
• Users can modify audit trails to improve readability

Correct Answer: System validation demonstrating it is fit for intended use and reliable

Q7. Which item is typically part of an SOP document header in GLP?

• Study budget details
• Revision number and effective date
• Personal phone numbers of staff
• Supplier marketing materials

Correct Answer: Revision number and effective date

Q8. Why is an audit trail important for electronic records in GLP?

• To allow unrestricted editing of historical entries
• To document who made changes, when and why, supporting data integrity
• So managers can delete irrelevant entries
• To enable external users to add comments directly

Correct Answer: To document who made changes, when and why, supporting data integrity

Q9. Which record should document any deviation from the approved study plan and the subsequent corrective action?

• Personnel training log
• Deviation/Incident Report with CAPA documentation
• Raw data file summary only
• Supplier certificate of analysis

Correct Answer: Deviation/Incident Report with CAPA documentation

Q10. In GLP archiving, a key requirement for archived records is that they must be:

• Stored in a personal office desk for convenience
• Accessible, protected from damage and retrievable for the retention period
• Destroyed immediately after study completion
• Left unsecured to allow rapid public access

Correct Answer: Accessible, protected from damage and retrievable for the retention period

Q11. Which of the following best describes the role of Quality Assurance (QA) in GLP documentation?

• QA writes the study protocol and performs experiments
• QA conducts independent audits and verifies that records support study conduct
• QA approves financial budgets for studies
• QA is responsible for marketing the final report

Correct Answer: QA conducts independent audits and verifies that records support study conduct

Q12. Chain of custody documentation for samples should include which of the following details?

• Only the sample name
• Transfer dates, responsible persons, condition and storage location
• General lab policies but not signatures
• Budget codes for the experiment

Correct Answer: Transfer dates, responsible persons, condition and storage location

Q13. Which action reflects good practice for signature controls on GLP documents?

• Use a shared electronic ID for the whole department
• Use unique, attributable signatures (handwritten or validated electronic) linked to the individual
• Allow anyone to sign on behalf of absent colleagues with no record
• Remove signatures when scanning documents to save space

Correct Answer: Use unique, attributable signatures (handwritten or validated electronic) linked to the individual

Q14. What should be included in the documentation of method validation under GLP?

• Only the final validated method title
• Full validation records showing parameters tested, results, acceptance criteria and conclusion
• Marketing claims from the instrument vendor
• Only the date when the method was first used

Correct Answer: Full validation records showing parameters tested, results, acceptance criteria and conclusion

Q15. When an electronic file containing raw GLP data is backed up, the backup process should be:

• Undocumented because backups are routine
• Documented, controlled and verifiable to ensure integrity and retrievability
• Handled only by external providers with no records
• Allowed to be overwritten without trace

Correct Answer: Documented, controlled and verifiable to ensure integrity and retrievability

Q16. Which statement about retention periods in GLP is correct?

• Retention periods are irrelevant for GLP compliance
• Retention should follow regulatory and sponsor agreements; records must be retained and retrievable for the agreed period
• Records can be discarded immediately after data analysis
• Only digital records need retention; paper may be discarded

Correct Answer: Retention should follow regulatory and sponsor agreements; records must be retained and retrievable for the agreed period

Q17. Which practice ensures the legibility of paper records over time?

• Use pencil for all entries so they can be erased if needed
• Use permanent ink, avoid fading pens, and store documents in suitable archival conditions
• Expose records to direct sunlight to keep them dry
• Allow multiple corrections without dating or initialing

Correct Answer: Use permanent ink, avoid fading pens, and store documents in suitable archival conditions

Q18. Which document records the final interpretation, conclusions and compliance statement of a GLP study?

• Raw chromatograms only
• Final Study Report
• Instrument maintenance log
• Supplier invoices

Correct Answer: Final Study Report

Q19. How should third-party data (e.g., CRO reports) be handled in GLP documentation?

• Accepted without verification and filed as final
• Evaluated, verified for GLP compliance and accompanied by certificates or original raw data where required
• Discarded to avoid confusion
• Only summarized with no supporting documents

Correct Answer: Evaluated, verified for GLP compliance and accompanied by certificates or original raw data where required

Q20. Which element is essential when documenting electronic signatures under GLP regulations?

• Electronic signatures may be anonymous
• Signatures must be attributable, unique to the individual, and linked to the record so that changes are detectable
• Electronic signatures need no security controls
• Signatures should be applied only to summaries, not original records

Correct Answer: Signatures must be attributable, unique to the individual, and linked to the record so that changes are detectable

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