Process deviations and deviation handling MCQs With Answer

Introduction: Process deviations and deviation handling are critical components of Quality Control and Quality Assurance in pharmaceutical manufacturing. For M.Pharm students, understanding deviations—unplanned events that may affect product quality or compliance—is essential for ensuring patient safety and regulatory conformity. This blog presents focused MCQs to deepen your grasp of deviation classification, investigation steps, root cause analysis tools, risk assessment, CAPA implementation, documentation practices, and regulatory expectations. Each question emphasizes practical decision-making and regulatory rationale, helping you prepare for professional roles in QC/QA as well as exams. Use these questions to test your knowledge and reinforce correct deviation management practices in a GMP environment.

Q1. What best defines a “process deviation” in pharmaceutical manufacturing?

• An unplanned event or departure from approved procedures that may affect product quality or compliance
• A planned change implemented through change control to improve process efficiency
• An analytical result outside specification limits (OOS) only
• Routine process variability within established control limits

Correct Answer: An unplanned event or departure from approved procedures that may affect product quality or compliance

Q2. Which of the following is the most appropriate first step after identifying a deviation?

• Immediately implement corrective actions without documentation
• Quarantine affected materials or products to prevent unintended use
• Close the deviation as minor and continue production
• Notify the regulatory authority before any internal assessment

Correct Answer: Quarantine affected materials or products to prevent unintended use

Q3. Which tool is most suitable for identifying potential root causes in a complex deviation involving multiple contributing factors?

• 5 Whys analysis
• Fishbone (Ishikawa) diagram
• Control chart
• Pareto chart

Correct Answer: Fishbone (Ishikawa) diagram

Q4. How should a deviation that results in a product failing to meet a critical quality attribute be classified initially?

• Minor deviation because it occurred during routine operations
• Major deviation due to potential impact on product safety or efficacy
• Administrative deviation because it involves paperwork
• Trendable event only, no investigation required

Correct Answer: Major deviation due to potential impact on product safety or efficacy

Q5. Which regulatory expectation is most relevant when documenting deviation investigations?

• Document only the final decision, omit interim steps
• Maintain a contemporaneous, thorough and retraceable record of investigation and rationale
• Store records only electronically without backups
• Only notify regulators if product recall is initiated

Correct Answer: Maintain a contemporaneous, thorough and retraceable record of investigation and rationale

Q6. What is the difference between an out-of-specification (OOS) result and a deviation?

• OOS always equals a deviation and requires no separate action
• A deviation is any departure from procedures; an OOS is a specific analytical result outside acceptance criteria that may trigger a deviation investigation
• Deviation pertains only to equipment failures; OOS pertains only to packaging
• There is no distinction; both terms are interchangeable

Correct Answer: A deviation is any departure from procedures; an OOS is a specific analytical result outside acceptance criteria that may trigger a deviation investigation

Q7. Which of the following actions is a corrective action (CA) rather than a preventive action (PA)?

• Updating SOP to prevent recurrence of the identified deviation
• Conducting training after a specific deviation to fix the identified issue
• Implementing a new monitoring plan to detect potential future issues
• Performing risk assessment for a potential future failure mode

Correct Answer: Conducting training after a specific deviation to fix the identified issue

Q8. In CAPA (Corrective and Preventive Action), what is the primary purpose of effectiveness checks?

• To document the initial deviation only
• To verify that corrective/preventive actions have reduced or eliminated the root cause and prevented recurrence
• To speed up deviation closure without evidence
• To allocate blame to responsible personnel

Correct Answer: To verify that corrective/preventive actions have reduced or eliminated the root cause and prevented recurrence

Q9. Which documentation practice is essential when handling deviations to ensure data integrity?

• Allow handwritten alterations without justification
• Use contemporaneous entries, sign/date changes, and provide documented justification for amendments
• Delete previous electronic records when correcting errors
• Rely on verbal approvals recorded later

Correct Answer: Use contemporaneous entries, sign/date changes, and provide documented justification for amendments

Q10. When is a trend analysis of deviations most useful?

• Only after a regulatory inspection
• As a proactive tool to identify recurring issues, systemic weaknesses, and opportunities for improvement
• Only for products that failed stability testing
• To justify not performing corrective actions

Correct Answer: As a proactive tool to identify recurring issues, systemic weaknesses, and opportunities for improvement

Q11. Which investigation outcome would most likely justify reworking a batch rather than rejecting it?

• Evidence of deliberate fraud affecting potency
• Deviation causing noncritical label misprint that can be corrected without compromising product quality
• Contamination with a pathogenic microorganism
• Unknown root cause with unresolved risk to patients

Correct Answer: Deviation causing noncritical label misprint that can be corrected without compromising product quality

Q12. Which statement best describes an emergency deviation?

• An uncontrolled change implemented without documentation or review
• A temporary, documented departure from batch or procedural requirements to prevent loss of life or to maintain product safety, followed by formal investigation
• A planned process improvement under routine change control
• A deviation that is never investigated if production pressures are high

Correct Answer: A temporary, documented departure from batch or procedural requirements to prevent loss of life or to maintain product safety, followed by formal investigation

Q13. What is the most appropriate way to prioritize deviation investigations?

• Investigate deviations in the order they are reported regardless of impact
• Use risk-based prioritization considering impact on patient safety, product quality, and regulatory compliance
• Only investigate deviations that are expensive to fix
• Prioritize deviations that affect packaging aesthetics

Correct Answer: Use risk-based prioritization considering impact on patient safety, product quality, and regulatory compliance

Q14. Which regulatory guideline emphasizes a pharmaceutical quality system including deviation handling and CAPA?

• ICH Q7 (Good Manufacturing Practice for Active Pharmaceutical Ingredients)
• ICH Q10 (Pharmaceutical Quality System)
• ISO 9001 only
• Pharmacopoeia monographs only

Correct Answer: ICH Q10 (Pharmaceutical Quality System)

Q15. Which element should NOT be omitted from a deviation investigation report?

• Root cause analysis and rationale for the chosen corrective/preventive actions
• Names of everyone present on the production floor even if unrelated
• Unverified assumptions without supporting data
• Only informal verbal notes

Correct Answer: Root cause analysis and rationale for the chosen corrective/preventive actions

Q16. How long should deviation records typically be retained according to good documentation practices?

• Until the next batch is produced
• For a defined period consistent with regulatory requirements, product shelf life, and company policy (often several years)
• One week after investigation closure
• Only until the inspector leaves the site

Correct Answer: For a defined period consistent with regulatory requirements, product shelf life, and company policy (often several years)

Q17. Which of the following is an example of a systemic deviation?

• A one-time labeling error caused by a new temporary staff member
• Repeated deviations caused by inadequate SOP design or ineffective training across multiple batches
• A single broken vial during transport with clear cause
• Minor, isolated equipment calibration delay that was documented and corrected

Correct Answer: Repeated deviations caused by inadequate SOP design or ineffective training across multiple batches

Q18. What role does risk assessment play in deciding product disposition after a deviation?

• Risk assessment is optional and rarely used for disposition
• Risk assessment helps determine the impact on safety, efficacy, and quality to guide decisions on release, rework, or rejection
• Risk assessment only applies to commercial manufacturing, not clinical batches
• Risk assessment should be performed after product release

Correct Answer: Risk assessment helps determine the impact on safety, efficacy, and quality to guide decisions on release, rework, or rejection

Q19. Which practice helps prevent recurring deviations related to operator performance?

• Ignore human factors and rely solely on disciplinary measures
• Implement competency-based training, assess effectiveness, and revise SOPs to reduce complexity
• Reduce documentation to avoid reporting deviations
• Increase production pressure to improve familiarity

Correct Answer: Implement competency-based training, assess effectiveness, and revise SOPs to reduce complexity

Q20. When should a deviation be trended and included in the management review?

• Only when there are more than 100 deviations
• Regularly, as part of quality metrics, to identify patterns and support continuous improvement
• Never; trending is unnecessary administrative work
• Only if regulators ask for it during an inspection

Correct Answer: Regularly, as part of quality metrics, to identify patterns and support continuous improvement

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