Goals of laboratory quality audit MCQs With Answer

Goals of Laboratory Quality Audit MCQs With Answer

This blog presents a focused set of multiple-choice questions on the goals of laboratory quality audits tailored for M.Pharm students. Laboratory quality audits are essential for ensuring compliance with regulatory standards, validating analytical methods, safeguarding data integrity, and driving continuous improvement. The questions dive into technical objectives such as verification of SOPs, equipment calibration, CAPA effectiveness, sample custody, and personnel competence, while also addressing strategic aims like risk-based audit planning and regulatory readiness. Use these MCQs to test conceptual understanding, prepare for practical audit scenarios, and strengthen readiness for inspections and quality assurance responsibilities in pharmaceutical laboratories.

Q1. What is the primary goal of a laboratory quality audit?

• Ensure compliance with regulatory and quality requirements
• Increase laboratory profit margins
• Promote new product development
• Replace external inspections permanently

Correct Answer: Ensure compliance with regulatory and quality requirements

Q2. Which of the following is a core objective when auditing laboratory procedures?

• Verify adequacy, clarity and implementation of standard operating procedures (SOPs)
• Evaluate marketing strategies for test services
• Assess the color scheme of laboratory documentation
• Determine potential for outsourcing all tests

Correct Answer: Verify adequacy, clarity and implementation of standard operating procedures (SOPs)

Q3. A key goal of laboratory audits related to data integrity is to:

• Assess data integrity based on ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, plus Completeness, Consistency, Longevity, and Availability)
• Ensure all raw data are destroyed after five years
• Require handwritten copies of electronic records only
• Encourage informal record-keeping to save time

Correct Answer: Assess data integrity based on ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, plus Completeness, Consistency, Longevity, and Availability)

Q4. During an audit, verifying the CAPA system aims to:

• Identify root causes and verify effectiveness of corrective and preventive actions (CAPA)
• Limit the number of corrective actions issued
• Ensure CAPAs are only implemented for major nonconformances
• Replace internal investigations with CAPA closure forms alone

Correct Answer: Identify root causes and verify effectiveness of corrective and preventive actions (CAPA)

Q5. One important goal of laboratory auditing concerning analytical methods is to:

• Verify that analytical methods are validated and performing within acceptance criteria
• Ensure methods are changed frequently to stay modern
• Keep all methods confidential from auditors
• Use only methods from a single vendor regardless of suitability

Correct Answer: Verify that analytical methods are validated and performing within acceptance criteria

Q6. A laboratory audit should confirm which equipment-related objective?

• Confirm calibration, maintenance and traceability of laboratory equipment
• Verify that equipment is aesthetically pleasing
• Ensure equipment manuals are stored offsite only
• Recommend immediate replacement of all equipment older than two years

Correct Answer: Confirm calibration, maintenance and traceability of laboratory equipment

Q7. Assessing personnel during a laboratory audit primarily seeks to:

• Assess staff competence, training and authorization for assigned laboratory tasks
• Measure staff productivity against sales targets
• Evaluate staff willingness to work overtime weekly
• Rank staff by seniority regardless of competency

Correct Answer: Assess staff competence, training and authorization for assigned laboratory tasks

Q8. Which audit goal focuses on samples and their handling?

• Evaluate sample handling, labeling, storage conditions and chain of custody
• Ensure samples are anonymized for marketing
• Require samples to be kept at room temperature only
• Recommend discarding samples after a single use with no records

Correct Answer: Evaluate sample handling, labeling, storage conditions and chain of custody

Q9. Documentation review during an audit aims to:

• Ensure completeness, accuracy and traceability of records for regulatory and internal review
• Reduce the volume of records by deleting historical data
• Standardize all documents to a single font regardless of content
• Promote informal verbal records over written records

Correct Answer: Ensure completeness, accuracy and traceability of records for regulatory and internal review

Q10. A laboratory quality audit contributes to continuous improvement by:

• Identifying systemic risks and opportunities for process optimization and improvement
• Enforcing a freeze on process changes indefinitely
• Focusing solely on individual human errors without process analysis
• Recommending outsourcing as the primary solution for problems

Correct Answer: Identifying systemic risks and opportunities for process optimization and improvement

Q11. Environmental controls are audited primarily to:

• Verify monitoring and control of laboratory environmental conditions (e.g., temperature, humidity, cleanliness) that affect product quality
• Ensure the laboratory lighting meets aesthetic standards
• Guarantee that all windows remain open for ventilation
• Limit environmental monitoring to annual checks only

Correct Answer: Verify monitoring and control of laboratory environmental conditions (e.g., temperature, humidity, cleanliness) that affect product quality

Q12. When auditing suppliers or contract laboratories, the audit goal is to:

• Assess qualification, performance history, and control measures of suppliers or contract labs
• Require suppliers to reduce prices regardless of quality
• Limit supplier assessment to financial stability only
• Replace supplier evaluation with informal phone checks

Correct Answer: Assess qualification, performance history, and control measures of suppliers or contract labs

Q13. Quality trending and use of control charts in a laboratory are audited to:

• Assess use of quality control charts and trending for ongoing performance monitoring and early detection of shifts
• Ensure all data are presented in narrative form rather than charts
• Restrict trending to once every five years
• Recommend removal of control limits to simplify reporting

Correct Answer: Assess use of quality control charts and trending for ongoing performance monitoring and early detection of shifts

Q14. Change control is audited to ensure that:

• All changes affecting methods, equipment or documentation are assessed, approved and communicated before implementation
• Changes are implemented immediately without review to save time
• Only management can propose changes, not technical staff
• Change documentation is optional for minor equipment adjustments

Correct Answer: All changes affecting methods, equipment or documentation are assessed, approved and communicated before implementation

Q15. A laboratory audit assessing regulatory compliance would check for adherence to:

• Applicable GLP, GMP and other relevant regulatory guidance and standards
• Only company-internal preferences regardless of external standards
• Informal practices that contradict written regulations
• Outdated standards that are no longer in force

Correct Answer: Applicable GLP, GMP and other relevant regulatory guidance and standards

Q16. One goal of audit follow-up is to:

• Ensure corrective actions are implemented timely and their effectiveness is verified
• Keep nonconformances open indefinitely
• Allow immediate closure of issues without verification
• Delegate closure responsibility only to external consultants

Correct Answer: Ensure corrective actions are implemented timely and their effectiveness is verified

Q17. A risk-based audit program is designed to:

• Prioritize audits and allocate resources based on process criticality and potential impact on product quality
• Audit all areas with equal frequency regardless of risk
• Focus only on low-risk activities to show high compliance rates
• Schedule audits randomly without assessing risk

Correct Answer: Prioritize audits and allocate resources based on process criticality and potential impact on product quality

Q18. Ensuring sample integrity during storage and transport is audited to:

• Confirm appropriate storage conditions, chain of custody and protection against contamination or degradation
• Allow sample mixing to save storage space
• Authorize unattended transport without monitoring
• Recommend indefinite storage without retention policies

Correct Answer: Confirm appropriate storage conditions, chain of custody and protection against contamination or degradation

Q19. One of the strategic goals of internal laboratory audits is to:

• Prepare the laboratory for external regulatory inspections by identifying weaknesses and demonstrating continual improvement
• Replace the need for any external inspections permanently
• Focus only on administrative presentation for visitors
• Limit audit findings to non-technical issues

Correct Answer: Prepare the laboratory for external regulatory inspections by identifying weaknesses and demonstrating continual improvement

Q20. Auditing laboratory electronic systems and LIMS commonly aims to:

• Evaluate system validation, user access control, audit trails and electronic record security
• Ensure all users share a single login to simplify access
• Disable audit trails to improve system speed
• Store electronic records only on local unbacked devices

Correct Answer: Evaluate system validation, user access control, audit trails and electronic record security

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