Introduction: Disqualification of testing facilities occurs when laboratory non-compliance threatens the accuracy, reliability, or integrity of pharmaceutical testing. B. Pharm students should understand causes such as data integrity breaches, inadequate method validation, poor documentation, improper sample handling, equipment calibration failures, and weak quality systems. Key regulatory concepts include ISO 17025, NABL accreditation, Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), CAPA, and regulatory inspections. Recognizing risks—contamination, chain of custody lapses, environmental control failures, and inadequate personnel training—helps prevent disqualification and protect public health. This topic integrates laboratory compliance, quality control, and corrective actions essential for pharmaceutical analysts. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is a primary regulatory reason for disqualification of a pharmaceutical testing facility?
- Falsification of analytical raw data
- Minor clerical errors in non-critical records
- Decorative changes in the laboratory
- Staff attending external conferences
Correct Answer: Falsification of analytical raw data
Q2. Which accreditation standard is most commonly recognized for laboratory competency and can influence disqualification decisions?
- ISO/IEC 17025
- GMP (Good Manufacturing Practice)
- GLP (Good Laboratory Practice)
- ICH Q10
Correct Answer: ISO/IEC 17025
Q3. Which of the following is a clear example of a data integrity violation that may lead to disqualification?
- Altering or deleting electronic chromatographic peaks without justification
- Using a validated method for testing
- Calibrating equipment at scheduled intervals
- Keeping signed training records
Correct Answer: Altering or deleting electronic chromatographic peaks without justification
Q4. Failure in which activity undermines the reliability of test results and can trigger regulatory action?
- Method validation and verification
- Posting laboratory photos on social media
- Providing staff with ergonomic chairs
- Purchasing new stationery
Correct Answer: Method validation and verification
Q5. Which laboratory practice is essential to maintain traceability and prevent disqualification?
- Complete chain of custody and sample identification
- Occasional informal verbal instructions
- Anonymous sample labeling
- Discarding sample receipt records after analysis
Correct Answer: Complete chain of custody and sample identification
Q6. Inadequate calibration of which equipment is most likely to cause non-conforming analytical results?
- Analytical balances and HPLC systems
- Office printers
- Break-room refrigerators used for staff lunches
- Decorative laboratory clocks
Correct Answer: Analytical balances and HPLC systems
Q7. Which documentation lapse is commonly cited in reports of facility disqualification?
- Missing or incomplete Standard Operating Procedures (SOPs)
- Excess color printing in reports
- Using digital signatures for approvals
- Excessive archiving of records
Correct Answer: Missing or incomplete Standard Operating Procedures (SOPs)
Q8. How does inadequate environmental monitoring contribute to disqualification risk?
- It allows undetected contamination affecting sample integrity
- It reduces the number of published papers
- It increases energy costs in the facility
- It speeds up analytical run times
Correct Answer: It allows undetected contamination affecting sample integrity
Q9. Which personnel-related issue can lead to a testing facility being disqualified?
- Lack of documented training and competency assessments
- High employee satisfaction scores
- Frequent social events for staff
- Rotating break schedules
Correct Answer: Lack of documented training and competency assessments
Q10. What is the role of CAPA in preventing disqualification of a testing lab?
- Identifying root causes and implementing corrective and preventive actions
- Reducing staff salaries
- Scheduling more non-audited weekends
- Eliminating peer reviews
Correct Answer: Identifying root causes and implementing corrective and preventive actions
Q11. Which regulatory body accreditation in India is most relevant when discussing laboratory disqualification?
- NABL (National Accreditation Board for Testing and Calibration Laboratories)
- US FDA
- EMA (European Medicines Agency)
- WHO prequalification only
Correct Answer: NABL (National Accreditation Board for Testing and Calibration Laboratories)
Q12. What type of audit finding usually has the greatest impact on disqualification decisions?
- Critical non-conformities affecting product safety or data integrity
- Minor formatting issues in reports
- Delays in non-essential procurement
- Suggestions for new laboratory paint color
Correct Answer: Critical non-conformities affecting product safety or data integrity
Q13. Why is sample storage condition monitoring important to avoid disqualification?
- Because temperature or humidity deviations can degrade samples and invalidate results
- Because it increases lab aesthetics
- Because it reduces electricity bills
- Because it shortens instrument run cycles
Correct Answer: Because temperature or humidity deviations can degrade samples and invalidate results
Q14. Which practice helps demonstrate compliance after a detected deviation to prevent disqualification?
- Documented investigation, root cause analysis, and effective CAPA
- Ignoring the deviation if results look acceptable
- Deleting the out-of-spec record
- Resubmitting work without documentation
Correct Answer: Documented investigation, root cause analysis, and effective CAPA
Q15. How does failure to participate in proficiency testing influence facility qualification status?
- It reduces confidence in laboratory competency and may contribute to disqualification
- It improves turnaround time of routine tests
- It increases laboratory revenue
- It has no regulatory relevance
Correct Answer: It reduces confidence in laboratory competency and may contribute to disqualification
Q16. Which record-keeping practice is essential to defend laboratory results during inspections?
- Complete, contemporaneous, and archived raw data with audit trails
- Handwritten notes without dates
- Destroying raw chromatograms after report generation
- Using personal notebooks not linked to sample IDs
Correct Answer: Complete, contemporaneous, and archived raw data with audit trails
Q17. Which of the following laboratory weaknesses most directly indicates a problem with process validation?
- Recurrent out-of-specification (OOS) results without documented investigation
- Excessive lunch breaks
- High-speed internet in the office area
- Frequent changes in test schedules
Correct Answer: Recurrent out-of-specification (OOS) results without documented investigation
Q18. What is the impact of poor vendor control on testing facility qualification?
- Unreliable reagents and reference standards leading to invalid tests
- Improved supplier relationships
- Lower storage costs
- Faster procurement cycles
Correct Answer: Unreliable reagents and reference standards leading to invalid tests
Q19. Which action by a laboratory during inspection can prevent immediate disqualification?
- Providing complete corrective action plans with timelines and evidence
- Refusing to show records
- Altering records on the spot
- Asking inspectors to postpone the audit indefinitely
Correct Answer: Providing complete corrective action plans with timelines and evidence
Q20. Which element of quality management is essential to prevent disqualification related to test methods?
- Robust method transfer, validation, and ongoing verification
- Occasional informal method tweaks
- Unauthorized method sharing via email
- Using legacy methods without performance checks
Correct Answer: Robust method transfer, validation, and ongoing verification
Q21. What consequence can arise from inadequate instrument maintenance records?
- Questioned reliability of results and potential facility disqualification
- Fewer scheduled calibrations
- Improved instrument uptime without documentation
- Decreased need for SOPs
Correct Answer: Questioned reliability of results and potential facility disqualification
Q22. Which of the following is a common root cause for repeated laboratory non-conformities?
- Poor quality culture and lack of management oversight
- Excessive staff recreation facilities
- Too many external trainings
- Over-documentation of trivial tasks
Correct Answer: Poor quality culture and lack of management oversight
Q23. Why is electronic record audit trail tampering a severe issue?
- It destroys the integrity and traceability of analytical data
- It speeds up data review
- It improves file organization
- It reduces storage needs
Correct Answer: It destroys the integrity and traceability of analytical data
Q24. Which preventive measure reduces the risk of facility disqualification related to sample contamination?
- Strict sample handling SOPs and environmental controls
- Allowing open sample exposure on benches
- Using unlabeled containers for convenience
- Sharing consumables across different workflows
Correct Answer: Strict sample handling SOPs and environmental controls
Q25. What documentation should a laboratory keep to show proficiency of analysts?
- Training records, competency assessments, and proficiency test results
- Only employment contracts
- Informal emails about training attendance
- Photographs of staff at work
Correct Answer: Training records, competency assessments, and proficiency test results
Q26. If a lab is disqualified, what immediate regulatory action may occur?
- Suspension of test reports and rejection of results for regulatory submissions
- Automatic increase in funding
- Immediate hiring spree
- Closure of unrelated business units only
Correct Answer: Suspension of test reports and rejection of results for regulatory submissions
Q27. How does improper disposal of hazardous waste contribute to disqualification risk?
- Leads to environmental non-compliance and regulatory penalties
- Reduces laboratory clutter
- Improves reagent availability
- Decreases record-keeping burden
Correct Answer: Leads to environmental non-compliance and regulatory penalties
Q28. Which practice helps restore accreditation after corrective actions following disqualification?
- Comprehensive implementation of CAPA with independent verification
- Ignoring audit recommendations
- Changing laboratory address only
- Replacing only junior staff
Correct Answer: Comprehensive implementation of CAPA with independent verification
Q29. What role does internal auditing play in preventing disqualification?
- Identifies gaps proactively and ensures compliance before external audits
- Replaces the need for external inspections entirely
- Only documents positive findings
- Delays corrective actions indefinitely
Correct Answer: Identifies gaps proactively and ensures compliance before external audits
Q30. Which element in a laboratory quality system demonstrates long-term commitment to avoid disqualification?
- Management review, resource allocation, continuous improvement, and documented quality policy
- Occasional team lunches
- Annual cosmetic renovations
- Ad-hoc decision making without records
Correct Answer: Management review, resource allocation, continuous improvement, and documented quality policy
I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.
Mail- Sachin@pharmacyfreak.com