Quality Control in Entrepreneurship MCQs With Answer

Introduction: This quiz collection on Quality Control in Entrepreneurship is tailored for M.Pharm students studying MIP 204T – Entrepreneurship Management. It covers the intersection of pharmaceutical quality control principles and entrepreneurial practices, emphasizing regulatory expectations, process validation, quality systems, and risk-based decision making for startups and small-scale manufacturers. The questions probe practical scenarios—SOPs, GMP, stability testing, analytical methods, CAPA, outsourcing responsibilities, and quality metrics—helping students apply technical QC knowledge to entrepreneurial contexts such as product development, outsourcing, and market release. Use these MCQs to assess readiness for quality-related decisions in pharmaceutical entrepreneurship and to reinforce core QC concepts essential for compliance and patient safety.

Q1. What is the primary objective of quality control (QC) within a pharmaceutical entrepreneurial venture?

• To design marketing strategies for product launch
• To ensure products meet predefined quality specifications through sampling and testing
• To minimize production costs regardless of product attributes
• To increase production speed without documentation

Correct Answer: To ensure products meet predefined quality specifications through sampling and testing

Q2. How does Quality Assurance (QA) differ from Quality Control (QC) in a pharmaceutical startup?

• QA focuses on product testing; QC designs the processes
• QA ensures the system and processes prevent defects; QC detects defects in products
• QA works only in marketing; QC works only in production
• QA and QC are identical and interchangeable

Correct Answer: QA ensures the system and processes prevent defects; QC detects defects in products

Q3. Which regulatory framework is most directly relevant to establishing manufacturing standards for a pharmaceutical entrepreneur?

• Good Distribution Practice (GDP)
• Good Clinical Practice (GCP)
• Good Manufacturing Practice (GMP)
• ISO 9001 for financial audits

Correct Answer: Good Manufacturing Practice (GMP)

Q4. What is the main purpose of Standard Operating Procedures (SOPs) in QC labs of a pharma startup?

• To provide optional suggestions for analysts
• To set step-by-step documented procedures ensuring consistency and traceability of tests
• To replace training requirements for new staff
• To advertise lab capabilities externally

Correct Answer: To set step-by-step documented procedures ensuring consistency and traceability of tests

Q5. CAPA in a pharmaceutical quality system stands for which of the following?

• Corrective and Preventive Action
• Control and Process Analysis
• Compliance and Product Approval
• Calibration and Performance Assessment

Correct Answer: Corrective and Preventive Action

Q6. Which type of validation is essential to demonstrate that an analytical method can reliably quantitate an active pharmaceutical ingredient in the presence of degradation products?

• Equipment qualification
• Stability validation
• Cleaning validation
• Method validation with stability-indicating capability

Correct Answer: Method validation with stability-indicating capability

Q7. What is the primary objective of accelerated stability testing in product development for entrepreneurs?

• To increase production throughput
• To estimate product shelf life and identify likely degradation pathways under stress
• To validate marketing claims
• To train quality personnel

Correct Answer: To estimate product shelf life and identify likely degradation pathways under stress

Q8. Statistical Process Control (SPC) tools, such as control charts, are used in QC to:

• Randomly accept batches without testing
• Monitor process variation and detect shifts or trends that may indicate loss of control
• Replace all laboratory testing with visual checks
• Eliminate the need for SOPs

Correct Answer: Monitor process variation and detect shifts or trends that may indicate loss of control

Q9. In quality terminology, how does verification differ from validation?

• Verification confirms a product meets user needs; validation checks specification compliance
• Verification checks that specified requirements are met; validation confirms the product fulfills its intended use
• They are identical processes with different names
• Verification is only for equipment; validation is only for software

Correct Answer: Verification checks that specified requirements are met; validation confirms the product fulfills its intended use

Q10. What is the role of acceptance criteria in QC testing for batch release?

• They provide optional guidance for investigators
• They define numerical or qualitative limits used to determine if a batch meets release specifications
• They are used only for marketing materials
• They allow each analyst to set personal thresholds

Correct Answer: They define numerical or qualitative limits used to determine if a batch meets release specifications

Q11. Why are statistically designed sampling plans important for QC in manufacturing?

• They ensure every unit is tested before release
• They provide a rational basis to obtain representative samples while balancing cost and risk
• They increase the number of out-of-specification results intentionally
• They replace the need for stability studies

Correct Answer: They provide a rational basis to obtain representative samples while balancing cost and risk

Q12. When a pharmaceutical entrepreneur outsources analytical testing to a contract laboratory, who retains ultimate responsibility for the test results and product quality?

• The contract laboratory alone
• The distributor of the product
• The sponsor/manufacturer (entrepreneur) retains ultimate responsibility
• The courier service transporting samples

Correct Answer: The sponsor/manufacturer (entrepreneur) retains ultimate responsibility

Q13. Which practice is essential for ensuring analytical instruments used in QC provide reliable data?

• Calibrating and qualifying instruments regularly and after any major repair
• Using instruments without maintenance to save costs
• Allowing any staff member to alter calibration settings
• Relying on supplier claims without local verification

Correct Answer: Calibrating and qualifying instruments regularly and after any major repair

Q14. Which root cause analysis tool is particularly useful for categorizing potential causes of a quality failure in manufacturing?

• Pareto chart
• Fishbone (Ishikawa) diagram
• Regression analysis exclusively
• Random sampling table

Correct Answer: Fishbone (Ishikawa) diagram

Q15. What is the main purpose of a change control system in a pharma quality management context?

• To allow immediate undocumented changes to speed up production
• To systematically evaluate and approve changes so product quality and regulatory compliance are preserved
• To document marketing strategy changes only
• To eliminate the need for validation activities

Correct Answer: To systematically evaluate and approve changes so product quality and regulatory compliance are preserved

Q16. Which statement best describes Quality by Design (QbD) as applied to pharmaceutical product development?

• Quality is tested solely at the final product stage
• Quality is achieved by designing a deep understanding of processes and controlling critical attributes from the start
• Quality means reducing documentation requirements
• QbD relies only on end-product inspection

Correct Answer: Quality is achieved by designing a deep understanding of processes and controlling critical attributes from the start

Q17. A stability-indicating analytical method is one that:

• Measures only the active ingredient without separating impurities
• Can accurately and selectively detect the active ingredient in the presence of its degradation products
• Is used only for packaging evaluation
• Requires no validation

Correct Answer: Can accurately and selectively detect the active ingredient in the presence of its degradation products

Q18. For accelerated stability testing, which model is commonly used to predict shelf life under normal storage by relating reaction rates to temperature?

• Henderson-Hasselbalch equation
• Arrhenius model
• Michaelis-Menten kinetics
• Gibbs free energy model

Correct Answer: Arrhenius model

Q19. Which metric is most useful for monitoring QC laboratory performance and identifying systemic issues?

• Number of marketing campaigns
• Out-of-specification (OOS) rate and trend of corrective actions
• Total sales revenue
• Number of social media followers

Correct Answer: Out-of-specification (OOS) rate and trend of corrective actions

Q20. Which types of audits should a pharmaceutical entrepreneur expect as part of a robust quality program?

• Only internal financial audits
• Internal audits, supplier audits, and regulatory inspections
• Only marketing performance audits
• None; audits are unnecessary for small ventures

Correct Answer: Internal audits, supplier audits, and regulatory inspections

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