GDP personnel and documentation requirements MCQs With Answer

Introduction: GDP personnel and documentation requirements MCQs With Answer is a focused quiz set designed for M.Pharm students preparing for advanced regulatory and quality assurance roles. These multiple-choice questions cover core aspects of Good Distribution Practices (GDP) with emphasis on personnel qualification, responsibilities, training, supervision, and comprehensive documentation practices such as SOPs, batch records, temperature logs, chain-of-custody, and data integrity principles. The questions probe deeper into compliance expectations, record retention, electronic versus paper records, and audit trail requirements to strengthen your conceptual understanding and practical readiness for inspections and quality operations in pharmaceutical distribution.

Q1. Which GDP principle specifically requires that personnel involved in distribution activities must have documented training records linked to their assigned duties?

• Competency-based training documented in personnel records
• General orientation without documentation
• On-the-job learning without records
• Informal supervision notes

Correct Answer: Competency-based training documented in personnel records

Q2. Under GDP, who is ultimately responsible for ensuring the adequacy of documentation systems within a distribution organization?

• Quality unit with documented authority and independence
• Logistics supervisor only
• External auditor after each inspection
• Individual warehouse employees

Correct Answer: Quality unit with documented authority and independence

Q3. Which document best defines the stepwise process for receipt, storage, picking and dispatch of medicinal products in a distribution center?

• Standard Operating Procedure (SOP) for warehouse operations
• Employee job description
• Invoice and packing list
• Emergency response plan

Correct Answer: Standard Operating Procedure (SOP) for warehouse operations

Q4. What documentation practice is essential to demonstrate traceability of a specific batch from manufacturer to customer?

• Complete chain-of-custody records including batch numbers and transaction dates
• Only retain shipping invoices without batch numbers
• Verbal confirmation recorded in meeting minutes
• Single consolidated monthly shipment summary

Correct Answer: Complete chain-of-custody records including batch numbers and transaction dates

Q5. Which ALCOA element is primarily upheld by electronic audit trails that record who performed an action and when?

• Attributable
• Legible
• Contemporaneous
• Original

Correct Answer: Attributable

Q6. For temperature-sensitive products, what documentation is required to demonstrate compliance during storage and transport?

• Validated temperature mapping and continuous temperature monitoring records
• One-time thermometer reading at receipt
• Driver’s statement of temperature control
• Customer acceptance note only

Correct Answer: Validated temperature mapping and continuous temperature monitoring records

Q7. Which personnel-related document is most critical to determine competence for loading and unloading hazardous medicinal consignments?

• Training records specific to handling hazardous medicinal consignments
• General employment contract
• Payroll records
• Annual company newsletter

Correct Answer: Training records specific to handling hazardous medicinal consignments

Q8. In GDP, how long should distribution records normally be retained to satisfy regulatory traceability requirements?

• At least as long as the shelf-life of the product plus one regulatory-specified period
• One month after dispatch
• Only until a customer confirms receipt
• Retain indefinitely without review

Correct Answer: At least as long as the shelf-life of the product plus one regulatory-specified period

Q9. Which documentation control measure prevents unauthorized changes to critical distribution records?

• Document change control with version numbering and approval signatures
• Allowing local clerks to edit files freely
• Storing only the latest file without revision history
• Printing and discarding older records weekly

Correct Answer: Document change control with version numbering and approval signatures

Q10. Which of the following best describes an effective training program for GDP personnel?

• Risk-based training curriculum, documented assessments and periodic refreshers
• One-time presentation during induction only
• Self-study with no assessments
• Training by peers without formal records

Correct Answer: Risk-based training curriculum, documented assessments and periodic refreshers

Q11. What is the primary purpose of a consignment note in GDP documentation?

• To provide shipment details, custody transfer evidence and recipient acknowledgment
• To replace product labeling
• To serve as an employment contract for drivers
• To list only invoice totals without batch details

Correct Answer: To provide shipment details, custody transfer evidence and recipient acknowledgment

Q12. How should deviations discovered in distribution records be handled according to GDP?

• Documented deviation report, root cause analysis, corrective and preventive actions, and management review
• Ignore minor deviations and proceed
• Correct records without documenting the change
• Delete the deviating records to avoid escalation

Correct Answer: Documented deviation report, root cause analysis, corrective and preventive actions, and management review

Q13. Which attribute of documentation ensures entries can be read and interpreted throughout the record retention period?

• Legibility and durable media
• Use of shorthand or scribbles
• Faded pencil on low-quality paper
• Temporary sticky notes attached to records

Correct Answer: Legibility and durable media

Q14. For electronic distribution records, what regulatory expectation ensures the authenticity and reliability of data?

• Validated electronic systems with secure access, audit trails and backup procedures
• Random deletion of older audit trails
• Single shared login for convenience
• Unvalidated spreadsheets emailed between staff

Correct Answer: Validated electronic systems with secure access, audit trails and backup procedures

Q15. Which personnel control helps prevent conflicts of interest and reduces risk of fraud in distribution activities?

• Separation of duties for ordering, receiving and record reconciliation
• Assigning all tasks to a single individual for speed
• Allowing drivers to authorize receipt themselves
• Combining finance and warehouse roles without checks

Correct Answer: Separation of duties for ordering, receiving and record reconciliation

Q16. Which record should be reviewed and signed by the quality unit before release of a batch for distribution?

• Batch distribution record including checks, reconciliations and storage conditions
• Casual delivery note without verification
• Internal memo with no signatures
• Job applicant resume

Correct Answer: Batch distribution record including checks, reconciliations and storage conditions

Q17. What documentation is recommended to demonstrate the competency of personnel responsible for temperature-controlled transport?

• Training certificates, transport qualification records and temperature monitoring reports
• Driver’s informal verbal assurance
• Vehicle registration only
• Receipt stamps without temperature data

Correct Answer: Training certificates, transport qualification records and temperature monitoring reports

Q18. Which practice supports integrity of manual records in a GDP environment?

• Use of indelible ink, dated entries, printed name and signature for each record entry
• Use of pencil that can be erased
• Allowing retrospective undocumented additions
• Crossing out and rewriting without initial/signature

Correct Answer: Use of indelible ink, dated entries, printed name and signature for each record entry

Q19. What is the regulatory expectation when outsourcing distribution activities regarding documentation?

• Formal written contract specifying responsibilities, record access, audit rights and documentation retention
• Verbal agreement with no documentation
• Outsourcer handles records with no oversight
• No requirement to define roles and responsibilities

Correct Answer: Formal written contract specifying responsibilities, record access, audit rights and documentation retention

Q20. Which indicator in documentation best demonstrates that personnel understand and follow GDP procedures?

• Completed training assessments, observed competency checks and documented deviations with corrective actions
• High staff turnover without training records
• Unverified oral confirmations of compliance
• Empty training logs

Correct Answer: Completed training assessments, observed competency checks and documented deviations with corrective actions

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