Preparation and maintenance of distribution records MCQs With Answer

Introduction:

This collection of multiple-choice questions focuses on the preparation and maintenance of distribution records, a critical area in Quality Control & Quality Assurance for M.Pharm students. Proper distribution records ensure traceability, regulatory compliance, product quality during transit, and readiness for recalls. The questions cover regulatory requirements, record elements, cold-chain documentation, electronic record controls, returns and destruction procedures, reconciliation, serialization, and practical aspects of SOPs and investigations. These MCQs are designed to test both conceptual understanding and practical application so students can confidently manage distribution documentation in pharmaceutical operations.

Q1. What is the primary purpose of maintaining distribution records in a pharmaceutical company?

• To provide sales forecasts for marketing
• To document expiry dates only
• To ensure traceability of finished products, enable recalls, and demonstrate regulatory compliance
• To replace batch production records

Correct Answer: To ensure traceability of finished products, enable recalls, and demonstrate regulatory compliance

Q2. Which retention period is commonly taught as a minimum for finished product distribution records under GMP guidance?

• Retain distribution records for 6 months after production
• Retain distribution records for at least one year after the expiry date of the batch
• Retain records only until the product is sold
• Retain records indefinitely without limit

Correct Answer: Retain distribution records for at least one year after the expiry date of the batch

Q3. Which of the following elements should always be included in a distribution record?

• Marketing strategy and customer feedback reports
• Batch number, quantity distributed, date, consignee name and address, transport conditions
• Employee payroll details
• Only the invoice number and total value

Correct Answer: Batch number, quantity distributed, date, consignee name and address, transport conditions

Q4. Who typically holds the primary responsibility for ensuring distribution records are prepared and maintained according to SOPs?

• The Head of Marketing
• The Head of IT
• The Head of Distribution/Logistics under QA oversight
• The cleaning staff supervisor

Correct Answer: The Head of Distribution/Logistics under QA oversight

Q5. What is the main objective of reconciling distribution records with batch production records?

• To validate suppliers’ invoices
• To ensure quantity shipped matches quantity produced and detect discrepancies or missing stock
• To calculate marketing margins
• To determine employee performance bonuses

Correct Answer: To ensure quantity shipped matches quantity produced and detect discrepancies or missing stock

Q6. Which regulatory standard governs the control and integrity of electronic distribution records in many jurisdictions?

• WHO GMP Annex 5 only
• ISO 9001 clauses only
• 21 CFR Part 11 and EU Annex 11 (electronic records and signatures)
• International Labor Organization (ILO) standards

Correct Answer: 21 CFR Part 11 and EU Annex 11 (electronic records and signatures)

Q7. What is the appropriate immediate action when distributed product is returned by a customer?

• Dispose of returned product immediately
• Quarantine returned goods, document the return, perform assessment and testing per SOP before disposition
• Resell the returned product if box appears undamaged
• Donate returned product to staff

Correct Answer: Quarantine returned goods, document the return, perform assessment and testing per SOP before disposition

Q8. For temperature-sensitive shipments, which of the following is an essential element to include in the distribution record?

• Only the courier’s name without temperature details
• Validated cold-chain packaging description and continuous temperature monitoring logs/data logger files for the shipment
• The marketing contact person
• Color of the outer packing

Correct Answer: Validated cold-chain packaging description and continuous temperature monitoring logs/data logger files for the shipment

Q9. How do distribution records support an effective product recall?

• They contain manufacturing formulas used in production
• They list all raw material suppliers only
• They identify all consignees, shipped quantities, and shipment dates to enable rapid retrieval of affected batches
• They are used only for tax accounting

Correct Answer: They identify all consignees, shipped quantities, and shipment dates to enable rapid retrieval of affected batches

Q10. Which documentation is necessary when destroying distributed product as part of a corrective action?

• An informal note in a notebook
• A documented destruction record with reasons, witness signatures, quantity destroyed, and final disposition
• A verbal approval from the warehouse staff
• Only an email without signatures

Correct Answer: A documented destruction record with reasons, witness signatures, quantity destroyed, and final disposition

Q11. Minimum required information on a shipping label for a pharmaceutical finished product typically includes which items?

• Product name, batch number, expiry date, storage conditions and quantity
• Employee ID of the packer and sales price
• Only the distributor’s logo
• Transport company’s internal tracking code only

Correct Answer: Product name, batch number, expiry date, storage conditions and quantity

Q12. Which practice most effectively improves traceability in distribution records?

• Using only generic product descriptions
• Applying serialization/unique identifiers and recording scan events along the supply chain
• Removing batch numbers to simplify records
• Relying solely on verbal confirmations

Correct Answer: Applying serialization/unique identifiers and recording scan events along the supply chain

Q13. What is the purpose of maintaining an audit trail for electronic distribution records?

• To allow anonymous edits without tracking
• To hide changes from auditors
• To provide a secure, time-stamped record of who made changes, when and why, supporting data integrity
• To increase storage costs intentionally

Correct Answer: To provide a secure, time-stamped record of who made changes, when and why, supporting data integrity

Q14. If a discrepancy is found between shipped quantity in the ledger and physical stock, what is the recommended sequence of actions?

• Ignore it if the difference is small
• Investigate immediately, quarantine affected stock, notify QA, and initiate CAPA if required
• Adjust the ledger without investigation
• Destroy remaining stock immediately

Correct Answer: Investigate immediately, quarantine affected stock, notify QA, and initiate CAPA if required

Q15. Why is linking customer complaints to distribution records important?

• To allocate marketing budget by complaint volume
• To determine which distribution routes or consignees and which batches are associated with the issue for investigation
• To increase product price based on complaints
• To delete historical sales data

Correct Answer: To determine which distribution routes or consignees and which batches are associated with the issue for investigation

Q16. How often should reconciliation of distribution records be performed in a well-controlled pharmaceutical facility?

• Never, reconciliation is unnecessary
• Only once every five years
• For each batch at release and periodically (e.g., monthly) for overall ledger reconciliation
• Only when an auditor requests it

Correct Answer: For each batch at release and periodically (e.g., monthly) for overall ledger reconciliation

Q17. Which of the following practices helps ensure the integrity of paper distribution records?

• Allowing unrestricted erasures and no signatures
• Using indelible ink, dating and signing entries, and following controlled amendment procedures
• Keeping records loose without filing
• Copying records only at year-end

Correct Answer: Using indelible ink, dating and signing entries, and following controlled amendment procedures

Q18. What should an SOP for preparation and maintenance of distribution records include?

• Only contact numbers of sales staff
• Procedures for record creation, review, retention, amendment, access control, electronic record controls and destruction
• Only marketing slogans
• Instructions to ignore minor discrepancies

Correct Answer: Procedures for record creation, review, retention, amendment, access control, electronic record controls and destruction

Q19. How does serialization (unique identifiers) in distribution records help combat counterfeit medicines?

• It increases packaging costs without benefits
• It allows verification of legitimate units and tracing the supply chain back to the manufacturer to detect falsified products
• It slows down distribution processes only
• It replaces all quality testing

Correct Answer: It allows verification of legitimate units and tracing the supply chain back to the manufacturer to detect falsified products

Q20. What is the key difference between a batch production record and a distribution record?

• Batch production record documents manufacturing steps and in-process data; distribution record documents movement, consignee details, and shipping conditions of finished goods
• There is no difference; they are identical
• Distribution records document raw material suppliers only
• Batch production records are only used by marketing

Correct Answer: Batch production record documents manufacturing steps and in-process data; distribution record documents movement, consignee details, and shipping conditions of finished goods

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