Introduction: This quiz collection on “Audit checklist for drug industries” is specially designed for M.Pharm students preparing for audits and regulatory compliance roles. It focuses on essential checklist elements used during internal and external audits in pharmaceutical manufacturing—covering documentation, GMP practices, validations, supplier qualification, CAPA, data integrity, laboratory controls, environmental monitoring, and regulatory inspection preparedness. Each question challenges your understanding of audit priorities, rationale behind checklist items, and practical corrective actions. Regular practice with these MCQs will sharpen your ability to identify critical gaps, prioritize findings, and support robust compliance strategies in the drug industry.
Q1. Which item is most critical to include in an audit checklist to verify control of electronic batch records?
- Physical storage location of paper backups
- Audit trail functionality and access controls
- Color of the user interface
- Number of printers available
Correct Answer: Audit trail functionality and access controls
Q2. During a GMP audit, what checklist item directly assesses process consistency for a manufacturing step?
- Review of personnel CVs
- Sampling plan for finished dosage forms
- Evaluation of in-process control data and trend analysis
- Inventory of office supplies
Correct Answer: Evaluation of in-process control data and trend analysis
Q3. Which checklist entry best evaluates supplier quality management during an audit?
- Supplier logo on invoices
- Existence of a supplier qualification and periodic re-evaluation program
- Delivery truck color
- Number of products supplied by vendor
Correct Answer: Existence of a supplier qualification and periodic re-evaluation program
Q4. What should an audit checklist require to verify adequacy of change control?
- Only verbal approvals for minor changes
- Documentation of risk assessment, approvals, and post-implementation review
- Change control log with unresolved items only
- Monthly social media updates
Correct Answer: Documentation of risk assessment, approvals, and post-implementation review
Q5. For cleaning validation, which checklist item confirms effectiveness of cleaning procedures?
- Cleaning frequency schedule without test results
- Validated cleaning method with acceptance limits based on toxicological assessment
- Pictures of cleaning staff
- List of detergents purchased
Correct Answer: Validated cleaning method with acceptance limits based on toxicological assessment
Q6. Which checklist point assesses laboratory data integrity?
- Number of analysts on staff
- Evidence of ALCOA+ principles: attributable, legible, contemporaneous, original, accurate, plus complete, consistent, enduring, and available
- Lab décor and layout
- Preferred lunch timings of analysts
Correct Answer: Evidence of ALCOA+ principles: attributable, legible, contemporaneous, original, accurate, plus complete, consistent, enduring, and available
Q7. What checklist item helps verify stability program compliance during an audit?
- Presence of stability chambers only
- Documented stability protocol, sampling plan, and trending of stability data versus specifications
- Brand of stability chamber
- Stability samples stored in offsite warehouses without records
Correct Answer: Documented stability protocol, sampling plan, and trending of stability data versus specifications
Q8. Which element on the checklist best evaluates recall readiness?
- Count of recall drills performed per year with documented outcomes and traceability of batches
- Number of phone lines in quality department
- Design of company logo
- Size of the marketing team
Correct Answer: Count of recall drills performed per year with documented outcomes and traceability of batches
Q9. To assess environmental monitoring, which checklist item is essential?
- Schedule of office cleaning
- Location-specific viable and non-viable monitoring records with action limits and trend review
- Types of floor tiles used
- Names of cleaning vendors only
Correct Answer: Location-specific viable and non-viable monitoring records with action limits and trend review
Q10. What should an auditor check to confirm adequate calibration control?
- Calibration certificates with traceability to national standards and defined recalibration frequency
- Number of calibrated instruments only
- Whether instruments are under warranty
- Brand names of instrument manufacturers
Correct Answer: Calibration certificates with traceability to national standards and defined recalibration frequency
Q11. Which audit checklist item ensures proper handling of OOS (Out of Specification) results?
- Immediate disposition of batch without investigation
- Formal documented investigation, hypothesis testing, and linkage to CAPA if root cause identified
- Throwing away results and retesting indefinitely
- Only notifying production verbally
Correct Answer: Formal documented investigation, hypothesis testing, and linkage to CAPA if root cause identified
Q12. For personnel training, what is a key checklist verification point?
- Training matrix with documented evidence of competency evaluations and signatures
- Staff social media profiles
- Personnel birthdates
- Number of years the trainer has worked in HR
Correct Answer: Training matrix with documented evidence of competency evaluations and signatures
Q13. Which checklist item is critical to evaluate packaging and labeling controls?
- Design color preferences for labels
- Label reconciliation procedures, control of label stock, and verification at packaging
- Number of label suppliers without qualification
- Storage of empty boxes in reception area
Correct Answer: Label reconciliation procedures, control of label stock, and verification at packaging
Q14. What should an audit checklist include to review water system compliance?
- Water vendor brochures
- Routine microbiological and chemical monitoring data with system maintenance and sanitization records
- Color of water pipes
- Number of faucets in the cafeteria
Correct Answer: Routine microbiological and chemical monitoring data with system maintenance and sanitization records
Q15. Which checklist item helps assess adequacy of batch record review?
- Presence of handwritten notes only
- Complete batch manufacturing records with documented review, approval signatures, and resolution of discrepancies before release
- Photographs of manufacturing floor only
- Marketing brochures for the product
Correct Answer: Complete batch manufacturing records with documented review, approval signatures, and resolution of discrepancies before release
Q16. To evaluate CAPA effectiveness, what should be on the audit checklist?
- CAPA records with root cause analysis, defined corrective/preventive actions, timelines, responsibilities, and verification of effectiveness
- List of CAPA coordinators without action details
- Number of complaints logged only
- CAPA folder color coding
Correct Answer: CAPA records with root cause analysis, defined corrective/preventive actions, timelines, responsibilities, and verification of effectiveness
Q17. Which checklist entry is most relevant to evaluate controlled substance handling in a drug facility?
- Location of cafeteria relative to storage
- Secure storage, access logs, reconciliation records, and regulatory permits
- Number of vending machines on site
- List of office keys issued
Correct Answer: Secure storage, access logs, reconciliation records, and regulatory permits
Q18. What should an auditor look for in the checklist to verify validation status of critical equipment?
- Evidence of completed IQ/OQ/PQ documentation with acceptance criteria and requalification plan
- Date of equipment purchase only
- Manufacturer’s marketing pamphlets
- Color of equipment paint
Correct Answer: Evidence of completed IQ/OQ/PQ documentation with acceptance criteria and requalification plan
Q19. Which checklist item best addresses handling of customer complaints during an audit?
- Complaint log with investigation records, impact assessment on product quality, and closure with trend analysis
- Only the quantity of complaints per month
- Customer names and addresses without investigation
- Sales response templates
Correct Answer: Complaint log with investigation records, impact assessment on product quality, and closure with trend analysis
Q20. To verify regulatory inspection preparedness, which checklist item is most important?
- Availability of a current regulatory binder with GMP policies, inspection history, response templates, and trained spokespeople
- Annual picnic planning documents
- Number of parking slots available for inspectors
- Design of the reception desk
Correct Answer: Availability of a current regulatory binder with GMP policies, inspection history, response templates, and trained spokespeople
