Record keeping and SOP development MCQs With Answer

Record keeping and SOP development MCQs With Answer – Introduction

This quiz set is designed to help M.Pharm students master core concepts of record keeping and Standard Operating Procedure (SOP) development, essential for pharmaceutical research and quality systems. It covers documentation principles (ALCOA and ALCOA+), SOP structure and lifecycle, controlled document management, data integrity, electronic records compliance (21 CFR Part 11), version and change control, archiving, deviation handling, and training documentation. Each question focuses on real-world practice and regulatory expectations so students can apply theoretical knowledge to laboratory, clinical research, and GMP environments. Use these MCQs to evaluate understanding and prepare for exams and inspections.

Q1. What is the primary purpose of maintaining accurate and contemporaneous laboratory records in pharmaceutical research?

• To create paperwork for administrative staff
• To ensure traceability, reproducibility and data integrity of experimental work
• To collect information for marketing purposes
• To permit unauthorized changes to data later

Correct Answer: To ensure traceability, reproducibility and data integrity of experimental work

Q2. Which of the following best describes the ALCOA principles widely used in pharmaceutical documentation?

• Accurate, Legible, Complete, Original, Available
• Attributable, Legible, Contemporaneous, Original, Accurate
• Accountable, Listed, Copyable, Ordered, Archived
• Anonymous, Legible, Compliant, Organized, Auditable

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

Q3. Which additional attributes are often appended to ALCOA to form ALCOA+?

• Accessible, Portable
• Complete, Consistent, Enduring, Available
• Certified, Legal
• Encrypted, Archived

Correct Answer: Complete, Consistent, Enduring, Available

Q4. Which element is NOT a required component of a well-written SOP?

• Purpose and scope
• Specific step-by-step procedure
• Personal opinions of the author
• Revision history and approval signature

Correct Answer: Personal opinions of the author

Q5. Who is typically responsible for approving and issuing an SOP in a regulated pharmaceutical environment?

• The person who wrote the SOP without review
• An authorized approver designated by the quality unit or management
• Any laboratory intern
• The external vendor

Correct Answer: An authorized approver designated by the quality unit or management

Q6. What is the main purpose of version control in SOP management?

• To randomly change document titles
• To prevent unauthorized reading of SOPs
• To ensure only the current, approved procedure is in use and historical versions are retained
• To increase file size of documents

Correct Answer: To ensure only the current, approved procedure is in use and historical versions are retained

Q7. Under Good Documentation Practices, how should an error in a paper record be corrected?

• Use white-out to hide the mistake and rewrite
• Strike through with a single line, initial, date, and add a reason if necessary
• Erase completely so the record looks neat
• Ask someone else to rewrite the whole page

Correct Answer: Strike through with a single line, initial, date, and add a reason if necessary

Q8. Which regulation specifically addresses electronic records and electronic signatures for FDA-regulated industries?

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

Correct Answer: 21 CFR Part 11

Q9. What is an audit trail in the context of electronic records?

• A printed copy of all electronic files
• A chronological record that shows who made changes, when, and what was changed
• A backup stored on a removable drive
• A list of usernames only

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

Q10. Which action is most appropriate when an SOP requires a minor procedural change that does not affect safety or data integrity?

• Make the change immediately without documenting it
• Initiate change control, revise the SOP, obtain approvals, and update the revision history
• Obsolete the SOP and stop the process permanently
• Ask staff to improvise without formal documentation

Correct Answer: Initiate change control, revise the SOP, obtain approvals, and update the revision history

Q11. Which of the following best describes a Master Document List (MDL)?

• A list of laboratory equipment warranties
• A control list that identifies current versions of controlled documents and where they are used
• A collection of meeting minutes
• A list of unscheduled tasks for personnel

Correct Answer: A control list that identifies current versions of controlled documents and where they are used

Q12. How long should critical research records typically be retained in a pharmaceutical academic or industry setting?

• Indefinitely, with no retention policy
• For a defined period consistent with institutional policy, applicable regulations, and the study sponsor (often several years post-study)
• Only until the next audit
• Until the lab space is needed

Correct Answer: For a defined period consistent with institutional policy, applicable regulations, and the study sponsor (often several years post-study)

Q13. What is the recommended practice for handling handwritten lab notebook entries to meet data integrity?

• Make entries retrospectively at the end of the month
• Make entries contemporaneously in ink, sign and date each entry, and reference related documents
• Type entries in a separate offline document only
• Allow anyone to edit others’ entries without annotation

Correct Answer: Make entries contemporaneously in ink, sign and date each entry, and reference related documents

Q14. Which document would describe the overall framework for document control, including roles, review cycles and archival procedures?

• Equipment manual
• Document Control SOP
• Vendor marketing brochure
• Clinical trial protocol

Correct Answer: Document Control SOP

Q15. What is the difference between a SOP and a Work Instruction?

• SOPs are marketing tools; work instructions are legal documents
• SOPs provide high-level policy and responsibilities; work instructions give detailed step-by-step tasks for specific activities
• There is no difference; they are always identical
• Work instructions are only for cleaning

Correct Answer: SOPs provide high-level policy and responsibilities; work instructions give detailed step-by-step tasks for specific activities

Q16. During an inspection, an inspector asks for training records showing competency in a revised SOP. Which file should you produce?

• Only the old version of the SOP without training records
• Training logs/certificates or records indicating personnel were trained and assessed against the current approved SOP revision
• Personal email exchanges unrelated to training
• Vendor invoices

Correct Answer: Training logs/certificates or records indicating personnel were trained and assessed against the current approved SOP revision

Q17. What should be included in an SOP revision history section?

• Names of everyone who read the SOP
• Revision number, date, summary of changes, author, and approver
• Only the date of creation
• Confidential comments about staff

Correct Answer: Revision number, date, summary of changes, author, and approver

Q18. Which of the following is a key control to ensure electronic data integrity in laboratory systems?

• Shared generic user accounts for convenience
• Unique user IDs, role-based access controls, audit trails and secure backups
• Disabling audit trails to improve performance
• Storing passwords on sticky notes near the workstation

Correct Answer: Unique user IDs, role-based access controls, audit trails and secure backups

Q19. How should deviations from an SOP be managed to meet regulatory expectations?

• Ignore them if no one notices
• Document the deviation, perform root cause analysis, assess impact on data and product, implement corrective/preventive actions, and update documents if necessary
• Delete the original records
• Ask staff to re-run experiments without documenting the prior deviation

Correct Answer: Document the deviation, perform root cause analysis, assess impact on data and product, implement corrective/preventive actions, and update documents if necessary

Q20. Which practice improves retrieval and long-term usability of archived paper and electronic records?

• Storing documents without indexing in random boxes
• Applying a consistent indexing scheme, metadata, environmental controls, and periodic integrity checks
• Archiving solely on obsolete media with no migration plan
• Keeping records only in the memory of senior staff

Correct Answer: Applying a consistent indexing scheme, metadata, environmental controls, and periodic integrity checks

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