This quiz set on “Introduction to validation and qualification concepts” is crafted for M.Pharm students preparing for advanced coursework and exams in Pharmaceutical Validation. It covers core definitions (DQ, IQ, OQ, PQ), process validation stages, cleaning and equipment qualification principles, risk-based approaches, sampling and statistical considerations, and practical regulatory expectations such as change control, revalidation triggers, and media-fill testing. The questions progress from fundamental concepts to applied scenarios and regulatory interpretation, reinforcing critical thinking required in real-world pharmaceutical manufacturing. Use these MCQs to test understanding, identify knowledge gaps, and prepare for filling validation roles or exam questions in master’s-level programs.
Q1. Which document defines the overall validation strategy, responsibilities, scope, and schedule for all validation activities within a pharmaceutical facility?
- Validation Protocol
- Standard Operating Procedure (SOP)
- Validation Master Plan (VMP)
- Quality Manual
Correct Answer: Validation Master Plan (VMP)
Q2. Design Qualification (DQ) primarily ensures which of the following?
- Equipment is installed according to manufacturer’s instructions
- The design of facilities, systems, and equipment meets user requirements and intended purpose
- Operational parameters are verified under working conditions
- The process consistently produces product meeting specifications
Correct Answer: The design of facilities, systems, and equipment meets user requirements and intended purpose
Q3. Installation Qualification (IQ) activities normally include:
- Verification of product quality after commercial production
- Testing the system across its operational ranges
- Documenting that equipment components, utilities, and ancillary systems are installed per design and manufacturer requirements
- Routine cleaning procedures and limits
Correct Answer: Documenting that equipment components, utilities, and ancillary systems are installed per design and manufacturer requirements
Q4. Operational Qualification (OQ) is best described as:
- Confirming that the manufacturing process design is capable of reproducible commercial manufacture
- Testing equipment and systems to demonstrate they function as intended throughout the defined range of operating parameters
- Verifying final product stability over shelf life
- Installing and calibrating equipment components
Correct Answer: Testing equipment and systems to demonstrate they function as intended throughout the defined range of operating parameters
Q5. Performance Qualification (PQ) focuses on which objective?
- Confirming that documented design meets regulatory codes
- Demonstrating that equipment performs effectively and reproducibly under routine, real-world conditions for a specified period, typically using production materials
- Verifying supplier quality systems
- Writing validation protocols
Correct Answer: Demonstrating that equipment performs effectively and reproducibly under routine, real-world conditions for a specified period, typically using production materials
Q6. Which validation approach is risk-based and emphasizes understanding and controlling critical process parameters to ensure critical quality attributes?
- Retrospective validation
- Prospective validation
- Process validation using Quality by Design (QbD) principles
- Commissioning
Correct Answer: Process validation using Quality by Design (QbD) principles
Q7. For process validation of a new solid oral dosage form, what is the commonly accepted number of consecutive conforming batches used in prospective PQ to demonstrate reproducibility?
- 1 batch
- 2 batches
- 3 batches
- 10 batches
Correct Answer: 3 batches
Q8. In cleaning validation, which parameter is the most appropriate primary acceptance criterion?
- Visual cleanliness
- Maximum allowable carryover based on toxicological limits (e.g., TTC or PDE) and assay limits for residues
- Number of cleaning cycles per day
- Time required to rinse equipment
Correct Answer: Maximum allowable carryover based on toxicological limits (e.g., TTC or PDE) and assay limits for residues
Q9. Which of the following best describes “worst case” selection in validation studies?
- Deliberately selecting the easiest process conditions to pass validation
- Selecting conditions or formulations that are most likely to challenge the process or equipment to ensure robustness
- Choosing the most expensive raw materials
- Randomly selecting batches without justification
Correct Answer: Selecting conditions or formulations that are most likely to challenge the process or equipment to ensure robustness
Q10. Bracketing and matrixing strategies are used primarily to:
- Reduce the number of validation tests while still providing adequate coverage of design space
- Increase the number of batches required in PQ
- Ensure every possible combination of conditions is tested exhaustively
- Replace the need for any validation documentation
Correct Answer: Reduce the number of validation tests while still providing adequate coverage of design space
Q11. Which stage of process validation according to FDA guidance focuses on ongoing assurance during routine production and continued monitoring?
- Stage 1 — Process Design
- Stage 2 — Process Performance Qualification
- Stage 3 — Continued Process Verification
- Stage 4 — Stability Validation
Correct Answer: Stage 3 — Continued Process Verification
Q12. A validation protocol typically includes all EXCEPT which of the following elements?
- Objective and scope
- Acceptance criteria and test methods
- Detailed batch manufacturing records for routine production after release
- Responsibilities and change control provisions
Correct Answer: Detailed batch manufacturing records for routine production after release
Q13. Which statistical concept is commonly used to determine whether a process is capable of meeting specification limits consistently?
- Control of vendor documentation
- Process capability indices such as Cp and Cpk
- Using only mean values without variability
- Qualitative visual inspection
Correct Answer: Process capability indices such as Cp and Cpk
Q14. What is the principal purpose of a media-fill (aseptic process simulation) test?
- To qualify equipment installation
- To simulate aseptic manufacturing using growth medium to challenge the process and assess contamination control effectiveness
- To validate cleaning agents
- To test stability of microbial cultures
Correct Answer: To simulate aseptic manufacturing using growth medium to challenge the process and assess contamination control effectiveness
Q15. Which event would most likely trigger revalidation of a process or equipment?
- Minor change in batch record font
- Significant modification in formulation, critical equipment, processing steps, or a change in supplier of a critical raw material
- Routine preventive maintenance performed as scheduled
- Introduction of a new employee
Correct Answer: Significant modification in formulation, critical equipment, processing steps, or a change in supplier of a critical raw material
Q16. Computer System Validation (CSV) differs from traditional equipment validation mainly because it focuses on:
- Physical installation only
- Regulatory filing formats
- Data integrity, lifecycle documentation (requirements, design, testing), and software/application behavior across versions
- Cleaning procedures
Correct Answer: Data integrity, lifecycle documentation (requirements, design, testing), and software/application behavior across versions
Q17. Retrospective validation is best described as:
- Validating processes using prospective studies before commercial manufacture
- Reviewing historical production and quality data from past batches to demonstrate process capability
- Testing equipment during installation
- Validation without any documentation
Correct Answer: Reviewing historical production and quality data from past batches to demonstrate process capability
Q18. Critical Quality Attributes (CQAs) are:
- Attributes of a product that have no impact on patient safety or efficacy
- Physical, chemical, biological or microbiological properties that must be controlled to ensure product quality and patient safety
- Only related to packaging appearance
- Only defined after product launch
Correct Answer: Physical, chemical, biological or microbiological properties that must be controlled to ensure product quality and patient safety
Q19. Which sampling strategy provides a statistically justified plan to demonstrate conformity to acceptance criteria with defined confidence and risk?
- Ad hoc sampling during production
- Risk-based sampling with statistical sample size determination (e.g., using confidence intervals, AQL or acceptance sampling plans)
- Sampling only the first and last units
- Sampling only after product release
Correct Answer: Risk-based sampling with statistical sample size determination (e.g., using confidence intervals, AQL or acceptance sampling plans)
Q20. Which of the following best represents an appropriate element to include in a validation report?
- Only a statement that validation was performed with no supporting data
- Summary of objectives, methods, results, deviations and investigations, conclusion on compliance with acceptance criteria, and recommendations for continued control
- Copy of unrelated SOPs
- Unverified verbal confirmations of testing
Correct Answer: Summary of objectives, methods, results, deviations and investigations, conclusion on compliance with acceptance criteria, and recommendations for continued control
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