Maintenance, retention and retrieval of documents MCQs With Answer

Introduction: Maintenance, retention and retrieval of documents is a critical area of Quality Control & Quality Assurance for M.Pharm students. This blog presents targeted MCQs to deepen understanding of document lifecycle in regulated pharmaceutical environments — from creation, version control and storage to retention schedules, archival, retrieval, and secure destruction. Emphasis is on regulatory expectations (data integrity, traceability, ALCOA principles, electronic records, and audit trails), practical best practices for documented procedures, and the role of QA in ensuring availability of records during inspections. These questions are designed to build competence for real-world QA responsibilities and regulatory examinations.

Q1. What is the primary purpose of maintaining and retaining pharmaceutical documents?

• To satisfy internal staff curiosity
• To ensure traceability, reproducibility and regulatory compliance for product quality and patient safety
• To make storage facilities look busy
• To provide marketing material for future promotions

Correct Answer: To ensure traceability, reproducibility and regulatory compliance for product quality and patient safety

Q2. Which set correctly represents the ALCOA+ principles widely applied to pharmaceutical records?

• Attributable, Legible, Contemporaneous, Original, Accurate plus Complete, Consistent, Enduring, Available
• Accessible, Large, Contained, Ordered, Archived
• Authentic, Locked, Compressed, Organized, Archived
• Available, Linked, Checked, Open, Archived

Correct Answer: Attributable, Legible, Contemporaneous, Original, Accurate plus Complete, Consistent, Enduring, Available

Q3. Which regulation in the United States specifically addresses electronic records and electronic signatures?

• 21 CFR Part 820
• 21 CFR Part 11
• ICH Q10
• GMP Annex 11

Correct Answer: 21 CFR Part 11

Q4. Which practice best describes robust version control for controlled documents?

• Overwriting the existing file without keeping history
• Using a unique version number, effective date, change history and documented approval signatures
• Keeping multiple copies on different employee desktops only
• Printing the document and hand-writing changes without approval

Correct Answer: Using a unique version number, effective date, change history and documented approval signatures

Q5. Who is primarily responsible for approving the document retention schedule in a pharmaceutical company?

• Marketing department
• Quality Assurance (QA) unit or department
• External audit firm only
• Warehouse staff

Correct Answer: Quality Assurance (QA) unit or department

Q6. Which statement is commonly recommended by many regulatory agencies regarding retention of Master Batch Records?

• Retain Master Batch Records for at least one year after the product’s expiration date
• Destroy Master Batch Records immediately after batch release
• Keep Master Batch Records only for one month after manufacture
• Retain Master Batch Records for seven days only

Correct Answer: Retain Master Batch Records for at least one year after the product’s expiration date

Q7. Which of the following is an example of a controlled document in a GMP environment?

• Standard Operating Procedure (SOP)
• Personal notes for a student project
• A public brochure advertisement
• Informal lunch menu

Correct Answer: Standard Operating Procedure (SOP)

Q8. What is the primary function of an indexed retrieval system for pharmaceutical documents?

• To make documents harder to find
• To enable quick, reliable location and retrieval of specific records during routine work and inspections
• To encrypt documents so no one can read them
• To replace retention schedules entirely

Correct Answer: To enable quick, reliable location and retrieval of specific records during routine work and inspections

Q9. What must be demonstrated when implementing an Electronic Document Management System (EDMS) in a GMP setting?

• No validation is needed as long as it runs on modern hardware
• The system is validated to ensure accuracy, reliability, consistent performance and ability to detect invalid or altered records
• Only the user interface needs testing
• The system must be open-source

Correct Answer: The system is validated to ensure accuracy, reliability, consistent performance and ability to detect invalid or altered records

Q10. Which characteristic describes a compliant audit trail for electronic records?

• Editable and deletable by any user
• Computer-generated, time-stamped, secure, and tamper-evident
• Stored as plain text on user laptops only
• Available only during working hours

Correct Answer: Computer-generated, time-stamped, secure, and tamper-evident

Q11. What is the correct approach to document destruction after the authorized retention period has elapsed?

• Destruction must follow an approved procedure and be recorded in a destruction log with authorization
• Throw documents in the general office trash without record
• Leave documents on a shelf indefinitely without action
• Allow any employee to decide on-the-spot whether to shred records

Correct Answer: Destruction must follow an approved procedure and be recorded in a destruction log with authorization

Q12. In the context of ALCOA, what is meant by the term “Original”?

• The most recent photocopy of a record
• The first-capture record or a certified true copy that reproduces the first-capture information
• A handwritten note on a napkin
• An unofficial summary created later

Correct Answer: The first-capture record or a certified true copy that reproduces the first-capture information

Q13. Which metric is most appropriate to measure the effectiveness of document retrieval processes during inspections?

• Mean time to retrieve critical inspection documents
• Number of printers in the QA office
• Size of the document storage room in square meters
• Number of colors used in document headers

Correct Answer: Mean time to retrieve critical inspection documents

Q14. When selecting an off-site archival vendor, which factor is most critical to ensure document integrity and retrievability?

• Proximity to a shopping mall
• Environmentally controlled storage, secure access, and documented chain-of-custody with retrieval guarantees
• Vendor’s marketing budget
• Availability of daily pizza delivery

Correct Answer: Environmentally controlled storage, secure access, and documented chain-of-custody with retrieval guarantees

Q15. When a controlled document requires revision, what must be included in the change process?

• Risk assessment, documented reasons for change, approval by authorized personnel, and maintained change history
• Immediate replacement without notification
• Deletion of the previous version without archive
• Informal verbal approval in a meeting with no record

Correct Answer: Risk assessment, documented reasons for change, approval by authorized personnel, and maintained change history

Q16. Which types of records should generally be retained beyond the product’s marketed life or expiry?

• Complaint investigations, adverse event reports and regulatory inspection records
• Only invoices older than ten years
• Old cafeteria menus
• Employee parking permits only

Correct Answer: Complaint investigations, adverse event reports and regulatory inspection records

Q17. Which item is NOT normally considered part of the formal document lifecycle in GMP document control?

• Creation, review, approval, distribution, revision, archival and destruction
• Version control and access control
• Marketing and sales campaign design unrelated to document authority
• Retention scheduling and retrieval indexing

Correct Answer: Marketing and sales campaign design unrelated to document authority

Q18. Why are unique document identifiers (such as document number and version) essential in a controlled document system?

• They help ensure traceability, prevent use of obsolete versions and support auditability
• They make documents harder to cite
• They are used only for decorative purposes
• They prevent any distribution of the document outside the company permanently

Correct Answer: They help ensure traceability, prevent use of obsolete versions and support auditability

Q19. During a regulatory inspection, what is the expected role of the QA department regarding retrieval of documents?

• Provide requested documents promptly, ensure they are authentic and explain their context to inspectors
• Refuse to provide any documents
• Provide only summaries and not original records
• Direct inspectors to external consultants for documents

Correct Answer: Provide requested documents promptly, ensure they are authentic and explain their context to inspectors

Q20. What is an essential element of a compliant electronic records backup strategy?

• Regular, automated backups with secure storage and periodic tested restoration procedures
• Manual copying of files once a year with no test
• Relying solely on the user’s memory to recall data
• Storing backups only on the same single workstation without redundancy

Correct Answer: Regular, automated backups with secure storage and periodic tested restoration procedures

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