Preparation and management of quality documentation MCQs With Answer

Preparation and management of quality documentation MCQs With Answer

Effective preparation and management of quality documentation is essential for B. Pharm students to understand pharmaceutical quality systems, Good Documentation Practice (GDP), Standard Operating Procedures (SOPs), batch records, data integrity, and regulatory compliance. This topic covers document lifecycle: creation, review, approval, version control, controlled copies, retention, archiving, and retrieval. Emphasis on validation records, change control, deviation reports, CAPA, audit trails, electronic records (21 CFR Part 11), and training documentation prepares students for industry expectations. Mastering these concepts ensures accurate, traceable, and compliant documentation supporting product quality, patient safety, and successful inspections. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. Which principle of Good Documentation Practice ensures entries are made at the time the activity is performed?

• Attributable
• Contemporaneous
• Legible
• Accurate

Correct Answer: Contemporaneous

Q2. What does ALCOA stand for in the context of data integrity?

• Accurate, Logged, Complete, Original, Authentic
• Attributable, Legible, Contemporaneous, Original, Accurate
• Accountable, Legal, Controlled, Original, Available
• Attributable, Logical, Consistent, Organized, Accessible

Correct Answer: Attributable, Legible, Contemporaneous, Original, Accurate

Q3. Which document defines stepwise manufacturing instructions and specifications for a pharmaceutical product?

• Change control form
• Master formula (Master Batch Record)
• Deviation report
• Training record

Correct Answer: Master formula (Master Batch Record)

Q4. Which of the following is NOT typically part of a document control system?

• Version control and revision history
• Controlled distribution list
• Random deletion of old documents
• Periodic review and approval workflow

Correct Answer: Random deletion of old documents

Q5. What is the primary purpose of an SOP (Standard Operating Procedure)?

• To serve as a marketing document
• To provide detailed, standardized instructions for performing tasks
• To replace training programs entirely
• To record batch yields only

Correct Answer: To provide detailed, standardized instructions for performing tasks

Q6. Which record documents the calibration status of laboratory equipment used in testing?

• Validation protocol
• Calibration certificate/log
• Batch production record
• Quality risk assessment

Correct Answer: Calibration certificate/log

Q7. Which attribute ensures a documented entry can be traced to the person who made it?

• Legibility
• Attributable
• Retained
• Archived

Correct Answer: Attributable

Q8. When an electronic record system is used, which regulation is commonly referenced for electronic signatures and audit trails?

• ICH Q9
• 21 CFR Part 11
• EU GMP Annex 1
• USP General Chapter

Correct Answer: 21 CFR Part 11

Q9. What should be done when a deviation from an SOP occurs during production?

• Ignore it if product looks fine
• Document the deviation, investigate root cause, and implement CAPA if needed
• Immediately destroy all related records
• Make an undocumented verbal note

Correct Answer: Document the deviation, investigate root cause, and implement CAPA if needed

Q10. Which document records the physical execution of a single production batch?

• Master formula
• Batch production record (BPR)
• Quality manual
• Change control report

Correct Answer: Batch production record (BPR)

Q11. How long should GMP documents typically be retained?

• Until the next audit only
• As specified by regulatory requirements and company policy, often several years beyond product shelf life
• One month
• Indefinitely without any retention schedule

Correct Answer: As specified by regulatory requirements and company policy, often several years beyond product shelf life

Q12. Which of the following best describes a controlled copy?

• An uncontrolled draft stored on a personal computer
• A version of a document maintained under the document control system with tracking of distribution and updates
• A photocopy for visitor reference
• A handwritten note on a lab bench

Correct Answer: A version of a document maintained under the document control system with tracking of distribution and updates

Q13. What information should a document header typically include?

• Only the author’s home address
• Document title, identification number, version, and effective date
• Confidential salary details
• Random unrelated notes

Correct Answer: Document title, identification number, version, and effective date

Q14. Which action demonstrates proper correction of an error on a paper record under GDP?

• Use correction fluid to obscure the mistake
• Strike through the error with a single line, initial, date, and write the correct entry
• Tear out the page and never mention it
• Rewrite the whole document without noting previous content

Correct Answer: Strike through the error with a single line, initial, date, and write the correct entry

Q15. What is the main role of a document reviewer/approver in quality documentation?

• To write marketing materials
• To verify technical accuracy, compliance, and approve for release
• To disregard regulatory requirements
• To store documents in personal files only

Correct Answer: To verify technical accuracy, compliance, and approve for release

Q16. Which document provides the plan and acceptance criteria for validating a manufacturing process?

• Validation protocol
• Deviation log
• Inventory list
• Employee handbook

Correct Answer: Validation protocol

Q17. What is the purpose of a training record in document management?

• To record employee vacations
• To document that personnel have been trained, qualified, and authorized to perform tasks
• To replace SOPs completely
• To store recipes for non-pharmaceutical items

Correct Answer: To document that personnel have been trained, qualified, and authorized to perform tasks

Q18. Which practise strengthens the security and integrity of electronic documents?

• Shared anonymous login credentials
• Role-based access control, audit trails, and secure backups
• Printing all documents and discarding originals
• Disabling audit trails to improve performance

Correct Answer: Role-based access control, audit trails, and secure backups

Q19. When issuing a revised SOP, what must be maintained for traceability?

• Only the new version without record of previous versions
• Revision history and archived superseded versions
• Removal of all distribution lists
• Deleting employee signatures

Correct Answer: Revision history and archived superseded versions

Q20. Which document records investigation findings and corrective actions after a quality incident?

• CAPA report (Corrective and Preventive Action)
• Storage log
• Marketing plan
• Daily production checklist

Correct Answer: CAPA report (Corrective and Preventive Action)

Q21. What should be included in a batch record to ensure product traceability?

• Personnel names, materials with lot numbers, equipment IDs, and timestamps
• Only the final yield
• Only supplier phone numbers
• An unrelated company newsletter

Correct Answer: Personnel names, materials with lot numbers, equipment IDs, and timestamps

Q22. Which type of document describes the procedure for handling changes to specifications, equipment, or processes?

• Change control procedure
• Cleaning validation report
• Product label
• Visitor sign-in sheet

Correct Answer: Change control procedure

Q23. What is an audit trail in the context of electronic records?

• A narrative marketing description
• A chronological record showing who made changes, when, and what was changed
• A physical trace of paper documents only
• A graphical chart of batch yields

Correct Answer: A chronological record showing who made changes, when, and what was changed

Q24. Which document is used to record raw material receipt, identification, and release for production?

• Material receipt and release record (or incoming material log)
• Financial invoice only
• Master formula
• Quality manual

Correct Answer: Material receipt and release record (or incoming material log)

Q25. Which practice ensures legibility of handwritten entries in quality records?

• Using faded ink to save paper
• Writing clearly in permanent ink and avoiding abbreviations unless defined
• Using pencil for all official entries
• Making entries on napkins

Correct Answer: Writing clearly in permanent ink and avoiding abbreviations unless defined

Q26. What is the role of SOPs in regulatory inspections?

• They are optional and not reviewed by inspectors
• They demonstrate controlled, consistent operations and form part of evidence during inspections
• They serve only as internal memos
• They are only for marketing personnel

Correct Answer: They demonstrate controlled, consistent operations and form part of evidence during inspections

Q27. Which practice is required when signing paper records to show responsibility?

• Sign using a shared team signature
• Sign with name, printed name or initials, and date in designated signature block
• Sign after the audit without dating
• Leave signature blank to be added later

Correct Answer: Sign with name, printed name or initials, and date in designated signature block

Q28. Which document describes the scope, responsibilities, and overall quality policy of a company?

• Quality manual
• Batch sampling plan
• Equipment logbook
• Material safety data sheet

Correct Answer: Quality manual

Q29. How should superseded paper documents be handled to prevent unintended use?

• Leave them on desks
• Withdraw and archive them with clear marking as superseded
• Burn them in the production area
• Recycle without tracking

Correct Answer: Withdraw and archive them with clear marking as superseded

Q30. Which record demonstrates the results and authorization for release of a finished pharmaceutical batch?

• Final product release certificate and associated QC test records
• Employee timesheet
• Raw material supplier catalogue
• Internal meeting minutes

Correct Answer: Final product release certificate and associated QC test records

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