Policy documents, procedures, work instructions and records MCQs With Answer

Introduction: Quality documentation forms the backbone of pharmaceutical Quality Control and Quality Assurance. For M.Pharm students, understanding policy documents, procedures, work instructions and records is essential to ensure compliance with regulatory expectations and Good Manufacturing Practices (GMP). This blog provides focused multiple-choice practice to reinforce concepts such as hierarchy of documents, document control, approval and revision processes, batch and analytical records, stability and validation documentation, deviation handling and corrective actions. These MCQs target deeper comprehension of responsibilities, retention requirements, traceability and practical scenarios commonly encountered in QC/QA roles, helping students prepare for exams and real-world pharmaceutical quality systems.

Q1. Which document establishes the overall intent and direction of an organization regarding quality and compliance?

• Work instruction describing laboratory assay steps
• Quality policy issued by top management
• Standard operating procedure for sampling
• Batch production record

Correct Answer: Quality policy issued by top management

Q2. What is the primary purpose of a Standard Operating Procedure (SOP) in a pharmaceutical setting?

• To record batch quantities and yield
• To define a high-level corporate goal
• To provide step-by-step methods for consistent performance of specific activities
• To serve as a training attendance list

Correct Answer: To provide step-by-step methods for consistent performance of specific activities

Q3. Which document type gives the most detailed, task-specific directions for a single action or tool use in the laboratory?

• Quality manual
• Work instruction
• Regulatory submission dossier
• Validation master plan

Correct Answer: Work instruction

Q4. Which of the following is an example of a record rather than a procedure or policy?

• Certificate of analysis (CoA) for released batch
• Procedure for deviation handling
• Retained sample policy
• Method validation protocol

Correct Answer: Certificate of analysis (CoA) for released batch

Q5. Which element is essential in a controlled document system to ensure traceability of revisions?

• Use of colored paper only
• Version number, revision history and effective date
• Handwritten notes without initials
• Archiving only the most recent document without records

Correct Answer: Version number, revision history and effective date

Q6. In GMP, who is ultimately responsible for approving quality policies and ensuring their implementation?

• Lab analyst
• Quality assurance head or top management
• External auditor
• Suppliers

Correct Answer: Quality assurance head or top management

Q7. How long should critical batch records generally be retained according to common regulatory expectations?

• Until the next batch is produced
• For a period defined in the retention policy, often at least 1–5 years after expiry or as specified by regulation
• Only until laboratory results are published
• Documents need not be retained if scanned

Correct Answer: For a period defined in the retention policy, often at least 1–5 years after expiry or as specified by regulation

Q8. Which document typically outlines the plan, scope and responsibilities for equipment qualification and process validation activities?

• Validation protocol or Validation Master Plan
• Daily logbook
• Training checklist
• Purchase order

Correct Answer: Validation protocol or Validation Master Plan

Q9. Which action is appropriate when an SOP is found to be outdated and affecting product quality?

• Continue using it until a regulatory inspection occurs
• Initiate controlled revision with change control, approval and retraining
• Discard the document without trace
• Allow operators to modify it informally on the shop floor

Correct Answer: Initiate controlled revision with change control, approval and retraining

Q10. What is the main difference between a procedure and a work instruction?

• Procedure is usually high-level describing what to do; work instruction gives detailed how-to steps for specific tasks
• Procedure is only for administrative tasks and work instruction is only for manufacturing
• There is no difference; they are interchangeable terms
• Procedures are informal while work instructions are formal

Correct Answer: Procedure is usually high-level describing what to do; work instruction gives detailed how-to steps for specific tasks

Q11. Which document should include signatures, dates and printed names to demonstrate authorization and accountability?

• Deviation report draft saved only on personal computer
• Controlled SOP without signature page
• Approved controlled documents and records such as batch records, COAs and SOP approvals
• Informal email instructions

Correct Answer: Approved controlled documents and records such as batch records, COAs and SOP approvals

Q12. During an audit, the auditor asks for the history of changes to an SOP. Which record demonstrates this?

• Training matrix
• Document revision history or change log
• Invoice from the printer
• Batch production record

Correct Answer: Document revision history or change log

Q13. Which of the following best describes “record” in QC/QA context?

• A policy stating management intent
• Evidence documenting activities performed and results obtained, providing traceability and accountability
• A draft SOP awaiting approval
• An informal memo between colleagues

Correct Answer: Evidence documenting activities performed and results obtained, providing traceability and accountability

Q14. What is the primary purpose of a change control procedure?

• To permit any change without documentation
• To evaluate, authorize and document changes to systems, equipment, documents or processes to maintain product quality
• To delay improvements indefinitely
• To record staff holidays

Correct Answer: To evaluate, authorize and document changes to systems, equipment, documents or processes to maintain product quality

Q15. Which record would most likely be used to investigate an out-of-specification (OOS) analytical result?

• Employee training attendance certificate only
• Analytical test record with raw data, instrument printouts and chromatograms
• Marketing brochure
• Purchase requisition

Correct Answer: Analytical test record with raw data, instrument printouts and chromatograms

Q16. Which statement about electronic records and signatures (ERES) is correct under regulatory expectations?

• Electronic records require no controls if stored on any personal device
• Electronic records and signatures must be secure, validated, and maintain audit trails equivalent to paper records
• Electronic signatures are not permitted in pharmaceutical industry
• Audit trails are optional for electronic systems

Correct Answer: Electronic records and signatures must be secure, validated, and maintain audit trails equivalent to paper records

Q17. What content is essential in a sampling procedure used for QC testing?

• Sampling location, sample size, sampling method, labeling, and chain of custody
• Only the analyst’s name
• Price of the sample container
• Marketing claims for the product

Correct Answer: Sampling location, sample size, sampling method, labeling, and chain of custody

Q18. Which of these is a key action after issuing a revised SOP that affects many employees?

• Expect employees to read it silently without confirmation
• Provide training or refresher training and document completion before implementation
• Delete the previous training records
• Only notify external auditors

Correct Answer: Provide training or refresher training and document completion before implementation

Q19. A retention policy states how long documents must be kept. Which of the following is NOT a reason for retention?

• To support product investigation and quality trending
• To provide evidence during regulatory inspections
• To enable historical traceability of decisions and manufacturing
• To intentionally obstruct timely disposal of outdated records for no purpose

Correct Answer: To intentionally obstruct timely disposal of outdated records for no purpose

Q20. In the document hierarchy, which sequence correctly orders documents from highest-level directive to most specific operational detail?

• Work instruction → Policy → SOP → Record
• Policy → SOP (procedure) → Work instruction → Record
• Record → Work instruction → SOP → Policy
• Invoice → Policy → SOP → Certificate

Correct Answer: Policy → SOP (procedure) → Work instruction → Record

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