Batch Packaging Records (BPR) MCQs With Answer

Introduction:
Batch Packaging Records (BPR) are vital documents in pharmaceutical manufacturing that capture every detail of the packaging stage for a specific batch. For M.Pharm students studying Documentation & Regulatory Writing, understanding BPRs is essential to ensure product traceability, regulatory compliance, and patient safety. A well-prepared BPR documents packaging materials, equipment, personnel, process parameters, in-process checks, label reconciliation, and final release decisions. It also helps identify deviations, supports investigations, and provides evidence during regulatory inspections. This quiz set explores core concepts, regulatory expectations, best practices, and common pitfalls associated with BPRs to deepen your practical and theoretical knowledge.

Q1. What is the primary purpose of a Batch Packaging Record (BPR)?

• To document the manufacturing process and raw material quantities
• To record the packaging operations and ensure traceability for a specific batch
• To provide financial costing details for product packaging
• To store marketing and distribution plans

Correct Answer: To record the packaging operations and ensure traceability for a specific batch

Q2. Which regulatory concept requires batch records, including BPRs, to be attributable, legible, contemporaneous, original, and accurate?

• Good Clinical Practice (GCP)
• ALCOA principles
• ICH Q9
• Pharmacovigilance guidelines

Correct Answer: ALCOA principles

Q3. Which of the following is a key difference between a Batch Manufacturing Record (BMR) and a Batch Packaging Record (BPR)?

• BMR documents packaging line activities; BPR documents synthesis steps
• BMR includes raw material sourcing; BPR details lab analytical methods
• BMR covers production/manufacturing operations; BPR focuses on packaging, labeling, and final reconciliation
• There is no difference; both are identical documents

Correct Answer: BMR covers production/manufacturing operations; BPR focuses on packaging, labeling, and final reconciliation

Q4. Which element is NOT typically part of a BPR?

• Identification and quantities of packaging materials used
• Packaging line equipment identity and parameters
• Final product stability study data
• Reconciliation of labels and containers

Correct Answer: Final product stability study data

Q5. When reconciling printed labels in a BPR, the expected practice is to:

• Count and record labels only at the start of packaging
• Reconcile labels by quantity and lot number before usage and at the end of packaging
• Trust the label vendor’s packing list without verification
• Record label reconciliation monthly for all batches

Correct Answer: Reconcile labels by quantity and lot number before usage and at the end of packaging

Q6. In the context of BPRs, what does “rejection and recovery” refer to?

• Financial penalties applied for late deliveries
• The process for recording and disposition of rejected packaging materials and salvaging recoverable items
• Marketing strategies for rejected product grades
• Legal actions taken against suppliers

Correct Answer: The process for recording and disposition of rejected packaging materials and salvaging recoverable items

Q7. Which signature practice is considered compliant for paper BPRs?

• Multiple personnel sharing a single signature to save time
• Use of initials without recorded full identity is acceptable
• Each responsible person signs with name, role, and date at the time of the activity
• Signatures can be backdated to match release date

Correct Answer: Each responsible person signs with name, role, and date at the time of the activity

Q8. For electronic Batch Packaging Records (eBPR), which is an important regulatory expectation?

• No audit trail is necessary if access is limited
• Electronic systems must provide secure access, audit trails, and data integrity controls
• Data can be deleted after verification without trace
• Backups are optional if cloud storage is used

Correct Answer: Electronic systems must provide secure access, audit trails, and data integrity controls

Q9. During packaging, an unexpected visual defect is detected in printed cartons. According to BPR best practices, the first action should be:

• Proceed with packaging and note the defect later
• Stop packaging, quarantine affected materials, document the defect, and initiate investigation
• Replace the packaging operator immediately without documenting
• Increase line speed to finish faster and avoid waste

Correct Answer: Stop packaging, quarantine affected materials, document the defect, and initiate investigation

Q10. Which retention period is generally recommended for BPRs in many regulatory jurisdictions?

• One month after batch release
• Until product expiry plus one year, or as per local regulations
• Two years regardless of product shelf life
• Retain only electronic summaries indefinitely

Correct Answer: Until product expiry plus one year, or as per local regulations

Q11. Which entry in a BPR should be made contemporaneously?

• Personal opinions about the batch written at month-end
• Real-time observations like line speed, checks performed, and quantities used
• Future batch projections
• Marketing comments from distribution team

Correct Answer: Real-time observations like line speed, checks performed, and quantities used

Q12. How should deviations observed during packaging be documented in the BPR?

• Ignored if they seem minor
• Logged with description, immediate corrective action, impact assessment, and reference to a deviation/investigation report
• Only discussed verbally among staff
• Recorded in a separate informal notebook not linked to the BPR

Correct Answer: Logged with description, immediate corrective action, impact assessment, and reference to a deviation/investigation report

Q13. Which of the following is essential when recording packaging material batch numbers in the BPR?

• Record only the supplier name without batch numbers
• Record full unique identifiers including material batch/lot number, supplier lot, and container IDs
• Record approximate lot numbers to save time
• Record batch numbers only for secondary packaging

Correct Answer: Record full unique identifiers including material batch/lot number, supplier lot, and container IDs

Q14. Label reconciliation discrepancies of unused labels found after packaging should trigger:

• No action if the quantity is small
• A documented investigation to determine cause, impact, and disposition of extra or missing labels
• Immediate release of product regardless
• Destruction of labels without documentation

Correct Answer: A documented investigation to determine cause, impact, and disposition of extra or missing labels

Q15. Which packaging parameter is commonly recorded in the BPR to ensure consistency?

• Employee shift patterns only
• Packaging line speed, seal integrity parameters, and torque settings
• Supplier payment terms
• Marketing campaign dates

Correct Answer: Packaging line speed, seal integrity parameters, and torque settings

Q16. How should corrections to entries in a paper BPR be made to remain compliant?

• Erase or use correction fluid to hide the original entry
• Strike through the incorrect entry with a single line, initial, date, and write the correct entry nearby
• Completely replace the page without note
• Use a new BPR for corrections only

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

Q17. In BPRs, reconciliation of containers (e.g., bottles) includes which of the following steps?

• Recording only the number used and ignoring leftovers
• Counting received, used, rejected, and remaining containers; documenting disposition of rejects
• Relying solely on machine counters without manual verification
• Recording totals weekly rather than per batch

Correct Answer: Counting received, used, rejected, and remaining containers; documenting disposition of rejects

Q18. Which statement about tamper-evident features and BPRs is true?

• Tamper-evident features do not need to be recorded in the BPR
• BPR should document verification that tamper-evident seals/closures are applied and checked during packaging
• Tamper-evident checks are the responsibility of distribution only
• Tamper-evident features are optional and not subject to documentation

Correct Answer: BPR should document verification that tamper-evident seals/closures are applied and checked during packaging

Q19. When a partial batch packaging is performed (e.g., due to equipment failure), the BPR must include:

• Only final quantities without explanation
• Details of cause, quantities packaged, quarantined material, reconciliation, and disposition plan
• Only the operator’s verbal account
• Just the original batch yield without updates

Correct Answer: Details of cause, quantities packaged, quarantined material, reconciliation, and disposition plan

Q20. Which control is important to prevent mislabeling and must be recorded in the BPR?

• Single-person handling of label application without checks
• Independent label check by a second qualified person before application
• Applying labels based on memory to speed up process
• Delaying label checks until after distribution

Correct Answer: Independent label check by a second qualified person before application

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