USFDA life cycle approach to process validation MCQs With Answer

Introduction

This quiz set explores the US FDA’s lifecycle approach to process validation, tailored for M.Pharm students preparing for advanced exams. The lifecycle model emphasizes a scientific, data-driven, and risk-based framework across three stages: Process Design, Process Qualification, and Continued Process Verification. Questions here cover core concepts such as identification of Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs), development of a control strategy, PPQ execution, statistical tools for monitoring, regulatory expectations, revalidation triggers, and quality systems integration. These MCQs are designed to deepen understanding, reinforce practical knowledge, and prepare students for real-world application of FDA expectations during product and process development.

Q1. What are the three stages of the US FDA lifecycle approach to process validation?

• Process Design, Process Qualification, Continued Process Verification
• Installation Qualification, Operational Qualification, Performance Qualification
• Prospective Validation, Concurrent Validation, Retrospective Validation
• Design of Experiments, Risk Assessment, Out-of-Specification Investigation

Correct Answer: Process Design, Process Qualification, Continued Process Verification

Q2. Which FDA guidance document formally introduced the lifecycle approach to process validation in 2011?

• Guidance for Industry: Process Validation — General Principles and Practices
• Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing
• Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations
• Guidance for Industry: Analytical Procedures and Methods Validation

Correct Answer: Guidance for Industry: Process Validation — General Principles and Practices

Q3. In Stage 1 (Process Design), what is the primary activity?

• Define the commercial manufacturing process and establish design space
• Execute PPQ batches to confirm process capability
• Implement routine monitoring and trending plans
• Perform installation and operational qualification of equipment

Correct Answer: Define the commercial manufacturing process and establish design space

Q4. Which term describes product attributes that must be controlled to ensure product quality?

• Critical Quality Attributes (CQAs)
• Operational Qualification Parameters (OQPs)
• Design Basis Elements (DBEs)
• Equipment Qualification Metrics (EQMs)

Correct Answer: Critical Quality Attributes (CQAs)

Q5. During Stage 2 (Process Qualification), what is the key deliverable?

• Process Performance Qualification (PPQ) demonstrating reproducible commercial manufacturing
• Initial risk assessment to identify CQAs
• Drafting the Validation Master Plan without execution
• Routine environmental monitoring program only

Correct Answer: Process Performance Qualification (PPQ) demonstrating reproducible commercial manufacturing

Q6. Continued Process Verification (Stage 3) primarily focuses on:

• Ongoing monitoring and control of the process to ensure it remains in a state of control
• Building equipment and facility infrastructure
• Initial identification of CPPs and CQAs
• Only stability testing of finished product

Correct Answer: Ongoing monitoring and control of the process to ensure it remains in a state of control

Q7. Which of the following best describes a Control Strategy in the lifecycle approach?

• A planned set of controls, derived from product and process understanding, that ensures product quality
• A list of equipment maintenance intervals only
• A sampling plan that replaces all in-process controls
• A single Critical Process Parameter to be monitored

Correct Answer: A planned set of controls, derived from product and process understanding, that ensures product quality

Q8. Which statistical measure is commonly used to assess process capability during PPQ?

• Process Capability Index (Cpk)
• Standard Error of the Mean (SEM)
• Coefficient of Determination (R²)
• Pearson Correlation Coefficient (r)

Correct Answer: Process Capability Index (Cpk)

Q9. Under the lifecycle approach, when is retrospective validation considered acceptable?

• For well-established, stable processes with extensive historical data and justified rationale
• Always, for any new product launch without prior process knowledge
• Never, retrospective validation is prohibited by FDA
• Only for sterile parenteral products manufactured in single-use systems

Correct Answer: For well-established, stable processes with extensive historical data and justified rationale

Q10. Which risk assessment tool is frequently used to prioritize potential failure modes affecting CQAs?

• Failure Mode and Effects Analysis (FMEA)
• Root Cause Analysis (RCA)
• Principal Component Analysis (PCA)
• Design of Experiments (DoE)

Correct Answer: Failure Mode and Effects Analysis (FMEA)

Q11. What is the purpose of Design of Experiments (DoE) in Stage 1?

• To systematically explore factor effects and interactions to define robust operating ranges
• To qualify utilities and services in the facility
• To document batch manufacturing records for release
• To monitor product stability under accelerated conditions

Correct Answer: To systematically explore factor effects and interactions to define robust operating ranges

Q12. Which of the following is considered a trigger for revalidation under the lifecycle approach?

• Significant change to materials, equipment, process parameters, or manufacturing site
• Routine preventive maintenance performed as scheduled
• Change in supplier contact information without material change
• Minor formatting changes to batch records

Correct Answer: Significant change to materials, equipment, process parameters, or manufacturing site

Q13. What role does data trending play in Continued Process Verification?

• It identifies process drift or trends that may indicate loss of control and need for corrective action
• It replaces the need for any in-process testing
• It is used only for cleaning validation data
• It is limited to visual inspection findings and non-statistical review

Correct Answer: It identifies process drift or trends that may indicate loss of control and need for corrective action

Q14. Which element is NOT typically part of a PPQ protocol?

• Marketing strategy and sales forecasts
• Acceptance criteria for CQAs and CPPs
• Number of production-scale batches to be executed
• Sampling and testing plans

Correct Answer: Marketing strategy and sales forecasts

Q15. How does Quality by Design (QbD) relate to the lifecycle approach?

• QbD provides product and process understanding used to establish design space and control strategy
• QbD is an alternative regulatory pathway unrelated to lifecycle validation
• QbD mandates retrospective validation for all products
• QbD requires elimination of in-process controls in favor of final product testing only

Correct Answer: QbD provides product and process understanding used to establish design space and control strategy

Q16. What is the significance of establishing a design space?

• Operating within the design space is not considered a change and provides regulatory flexibility
• It identifies the exact single setpoint for all process parameters to never be varied
• It is a marketing claim with no regulatory implications
• It exempts the manufacturer from GMP requirements

Correct Answer: Operating within the design space is not considered a change and provides regulatory flexibility

Q17. Which monitoring approach is emphasized in Stage 3 for timely detection of process deviations?

• Real-time or near real-time monitoring and appropriate statistical control
• Annual review of a single retained sample only
• Exclusive use of end-product testing without in-process checks
• Visual inspection of operators only

Correct Answer: Real-time or near real-time monitoring and appropriate statistical control

Q18. What is the recommended action when an OOS result suggests the process is trending out of control during continued verification?

• Investigate root cause, perform risk assessment, and take appropriate corrective and preventive actions (CAPA)
• Ignore the result if one batch previously passed all tests
• Immediately change the product specification to fit results
• Delay investigation until annual product quality review

Correct Answer: Investigate root cause, perform risk assessment, and take appropriate corrective and preventive actions (CAPA)

Q19. In the lifecycle model, what documentation is central to managing and coordinating all validation activities?

• Validation Master Plan (VMP)
• Daily production logbook without summary
• Marketing authorization dossier only
• Supplier brochures and promotional materials

Correct Answer: Validation Master Plan (VMP)

Q20. Which one of the following best describes a surrogate parameter used in process monitoring?

• An indirect measurement correlated to a CQA that can be monitored more rapidly or continuously
• An unrelated environmental measurement used for facility aesthetics
• A marketing metric used to assess product acceptance
• A parameter that replaces all laboratory testing permanently

Correct Answer: An indirect measurement correlated to a CQA that can be monitored more rapidly or continuously

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