Report preparation and distribution records MCQs With Answer

Report preparation and distribution records MCQs With Answer is an essential study area for B.Pharm students focusing on accurate documentation, regulatory compliance, and quality systems. This topic covers report preparation, formatting, content requirements, distribution logs, controlled copies, retention, archival, SOPs, GLP/GMP principles, electronic records, audit trails, data integrity (ALCOA+), and chain of custody. Mastery helps in QC/QA activities, regulatory inspections, batch release, and CAPA documentation. Practical skills include creating clear reports, maintaining distribution records, version control, and ensuring authorized access. These core competencies support patient safety and product quality through reliable documentation practices. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary purpose of distribution records in pharmaceutical practice?

• To document formulation recipes used during manufacturing
• To track distribution and receipt of finished products
• To record staff training schedules
• To list laboratory equipment calibration dates

Correct Answer: To track distribution and receipt of finished products

Q2. Which element is essential when preparing a formal quality report?

• Detailed marketing plan
• Clear statement of objective and scope
• Personal opinions of staff
• Only raw data without interpretation

Correct Answer: Clear statement of objective and scope

Q3. ALCOA is a data integrity acronym. What does the “C” stand for?

• Complete
• Contemporaneous
• Consistent
• Confidential

Correct Answer: Contemporaneous

Q4. Which regulation specifically addresses electronic records and electronic signatures in the US?

• ICH Q7
• 21 CFR Part 11
• EU Annex 1
• ISO 9001

Correct Answer: 21 CFR Part 11

Q5. What is a “controlled copy” of a document?

• A draft version for internal review only
• An unofficial copy kept for reference
• An authorized copy issued with distribution control
• A personal note version of the master

Correct Answer: An authorized copy issued with distribution control

Q6. Which section is typically included in a laboratory report?

• Vendor marketing brochure
• Method, results, discussion, and conclusion
• Employee salaries
• Company strategic plan

Correct Answer: Method, results, discussion, and conclusion

Q7. Distribution records should be retained according to:

• Only verbal agreements
• Company SOPs and applicable regulatory requirements
• Employee preference
• Marketing department timelines

Correct Answer: Company SOPs and applicable regulatory requirements

Q8. What is the primary risk of poor report formatting and unclear records?

• Reduced tablet hardness
• Regulatory non-compliance and misinterpretation of data
• Increased advertising costs
• Higher inventory levels

Correct Answer: Regulatory non-compliance and misinterpretation of data

Q9. An audit trail in electronic records is used to:

• Track changes and who made them
• Delete unwanted entries automatically
• Create marketing reports
• Hide authorization signatures

Correct Answer: Track changes and who made them

Q10. Which practice helps ensure distribution records are reliable?

• Allowing multiple untracked edits
• Maintaining version control and signature authorization
• Storing records only on personal devices
• Using ambiguous identifiers

Correct Answer: Maintaining version control and signature authorization

Q11. What is included in a master batch record distribution log?

• Supplier phone numbers only
• Details of shipped batches, recipients, dates, and quantities
• Employee vacation schedules
• Marketing forecasts

Correct Answer: Details of shipped batches, recipients, dates, and quantities

Q12. Which quality system addresses corrective and preventive actions related to reports?

• CAPA
• FIFO
• ERP
• CRM

Correct Answer: CAPA

Q13. When distributing confidential reports, which control is most important?

• Open public posting
• Access restricted to authorized personnel only
• Printing unlimited copies
• Sharing via personal emails

Correct Answer: Access restricted to authorized personnel only

Q14. What does “retention period” refer to in distribution records management?

• Time to wait before first distribution
• Duration records must be stored before disposal
• Time to manufacture a batch
• Period for employee appraisal

Correct Answer: Duration records must be stored before disposal

Q15. Which of the following is a best practice for electronic report backups?

• Single local copy only
• Regular automated backups with off-site storage
• No backups to save space
• Manual copying to random USB drives

Correct Answer: Regular automated backups with off-site storage

Q16. Which document defines who receives specific reports within a company?

• Distribution list or distribution matrix
• Employee handbook
• Marketing campaign plan
• Supplier invoice

Correct Answer: Distribution list or distribution matrix

Q17. Which entry should always be present on a signed report page?

• Signature, printed name, date, and authorized title
• Employee social media handle
• Personal phone number
• Handwritten margin notes without date

Correct Answer: Signature, printed name, date, and authorized title

Q18. A deviation report should document all EXCEPT:

• Description of the deviation
• Immediate containment actions
• Root cause analysis and corrective actions
• Irrelevant rumors about staff

Correct Answer: Irrelevant rumors about staff

Q19. Which is a characteristic of a well-prepared distribution record?

• Ambiguous recipient identifiers
• Clear recipient name, address, batch number, and date
• Missing batch numbers
• Handwritten entries with no signature

Correct Answer: Clear recipient name, address, batch number, and date

Q20. Which practice supports data integrity in report preparation?

• Allowing post-hoc undocumented changes
• Using audit trails and timestamped entries
• Deleting raw data after summary is made
• Sharing passwords among staff

Correct Answer: Using audit trails and timestamped entries

Q21. What is the role of SOPs in report preparation and distribution?

• SOPs are optional suggestions
• They provide standardized procedures and responsibilities
• SOPs are only for production staff
• SOPs replace regulatory requirements

Correct Answer: They provide standardized procedures and responsibilities

Q22. In a distribution log, the “chain of custody” documents:

• Financial transactions only
• Transfer of product custody from one party to another
• Marketing approvals
• Only manufacturing yields

Correct Answer: Transfer of product custody from one party to another

Q23. Which format is preferred for long-term archival of critical records?

• Encrypted electronic format with integrity checks
• Handwritten notes on loose paper
• Photographs stored on a personal phone
• Temporary clipboard files

Correct Answer: Encrypted electronic format with integrity checks

Q24. Version control in report documents ensures:

• Multiple conflicting copies circulate
• The latest approved version is identified and distributed
• No record of changes is kept
• All drafts are treated as final

Correct Answer: The latest approved version is identified and distributed

Q25. During inspections, regulators often review distribution records to verify:

• Product marketing slogans
• Traceability of products and compliance with release procedures
• Employee salaries
• Office supply inventory

Correct Answer: Traceability of products and compliance with release procedures

Q26. What should be done if an error is found in a printed report page?

• Erase it without record
• Follow SOP for corrections: strike-through, initial, date, and remark
• Discard the entire report silently
• Ignore and proceed

Correct Answer: Follow SOP for corrections: strike-through, initial, date, and remark

Q27. Which of these is NOT a component of an effective distribution record?

• Recipient signature upon receipt
• Product batch number and quantity
• Unverified verbal confirmations only
• Date and time of shipment or receipt

Correct Answer: Unverified verbal confirmations only

Q28. How does metadata support electronic distribution records?

• By providing context like author, timestamps, and version
• By deleting original data automatically
• By obscuring user identities
• By converting files to images only

Correct Answer: By providing context like author, timestamps, and version

Q29. Which practice improves traceability during product recall?

• Maintaining detailed distribution records linked to batch numbers
• Removing all shipping labels
• Using generic batch identifiers for all products
• Storing distribution records without dates

Correct Answer: Maintaining detailed distribution records linked to batch numbers

Q30. What is an important consideration when distributing reports externally to regulatory bodies?

• Ensure reports are unsigned and unsigned data only
• Follow confidentiality, authorized distribution list, and required formatting
• Send internal draft versions without approval
• Use personal email accounts for transmission

Correct Answer: Follow confidentiality, authorized distribution list, and required formatting

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