Understanding Product Life Cycle (PLC) and Product Life Cycle Management (PLCM) is essential for B.Pharm students preparing to enter the pharmaceutical industry. This topic covers stages from drug discovery and development, clinical trials, regulatory approval, market introduction, growth, maturity and decline, plus strategies for lifecycle extension, portfolio management, pricing, patent expiry and post-marketing surveillance. Emphasis on quality, cGMP, pharmacovigilance, tech transfer, scale-up and regulatory submissions links science with commercial and safety responsibilities. Familiarity with PLC concepts helps pharmacists plan development timelines, ensure compliance, optimize product performance and manage risks across a drug’s lifespan. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. Which stage of the product life cycle is primarily focused on clinical trials and regulatory approval?
- Introduction stage
- Development stage
- Maturity stage
- Decline stage
Correct Answer: Development stage
Q2. What does PLCM stand for in pharmaceutical industry context?
- Product Labelling and Compliance Management
- Product Life Cycle Management
- Pharmacovigilance Lifecycle Mapping
- Production Logistics and Cost Management
Correct Answer: Product Life Cycle Management
Q3. Which activity is most important during the introduction phase of a pharmaceutical product?
- Maximizing market share through generics
- Conducting phase IV post-marketing studies
- Building awareness and initial physician adoption
- Implementing product discontinuation plans
Correct Answer: Building awareness and initial physician adoption
Q4. Patent expiry most directly influences which PLC stage transition?
- Development to introduction
- Introduction to growth
- Growth to maturity
- Maturity to decline
Correct Answer: Maturity to decline
Q5. Which strategy is commonly used to extend the commercial life of a drug?
- Line extension through new formulations or indications
- Immediate full price reduction on launch
- Stopping pharmacovigilance after two years
- Removing patents before approval
Correct Answer: Line extension through new formulations or indications
Q6. Which regulatory submission is typically required before market introduction of a new drug?
- Marketing Authorization Application (MAA) or New Drug Application (NDA)
- Abbreviated New Drug Application (ANDA)
- Investigational New Drug (IND) application
- Periodic Safety Update Report (PSUR)
Correct Answer: Marketing Authorization Application (MAA) or New Drug Application (NDA)
Q7. Pharmacovigilance is most relevant to which PLC activities?
- Preclinical pharmacology only
- Post-marketing safety monitoring and risk management
- Patent filing and prosecution
- Manufacturing equipment qualification
Correct Answer: Post-marketing safety monitoring and risk management
Q8. What is a key objective of tech transfer during product lifecycle?
- Replace clinical testing with in vitro assays
- Move and scale up manufacturing while maintaining product quality
- Eliminate quality control testing to reduce costs
- Transfer marketing rights to generic manufacturers
Correct Answer: Move and scale up manufacturing while maintaining product quality
Q9. Which of the following best describes the maturity stage of a drug product?
- Rapid sales growth with low competition
- Stable sales with strong competition and pricing pressures
- No clinical data and preclinical only
- Only specialty use in small patient populations
Correct Answer: Stable sales with strong competition and pricing pressures
Q10. What is SUPAC in context of pharmaceutical lifecycle management?
- Guidelines for scale-up and post-approval changes
- Pharmacovigilance reporting standard
- Patent extension program
- Clinical trial randomization method
Correct Answer: Guidelines for scale-up and post-approval changes
Q11. Which study is essential to demonstrate bioequivalence when generics enter the market?
- Phase I safety study
- Bioequivalence (BE) study
- Phase III efficacy trial
- Stability indicating assay validation
Correct Answer: Bioequivalence (BE) study
Q12. During the decline stage, which action is most appropriate from a PLCM perspective?
- Increase promotional spend aggressively
- Consider product withdrawal, lifecycle cost reduction or niche repositioning
- File new patents for the same molecule without data
- Ignore supply chain and quality control
Correct Answer: Consider product withdrawal, lifecycle cost reduction or niche repositioning
Q13. Which metric is commonly used to evaluate commercial performance across PLC stages?
- Number of clinical sites only
- Sales revenue and market share trends
- Amount of raw material ordered
- Number of patent pages filed
Correct Answer: Sales revenue and market share trends
Q14. Which department is primarily responsible for pharmacovigilance activities in a pharmaceutical company?
- Manufacturing
- Regulatory affairs and safety/pharmacovigilance
- Supply chain
- Facilities maintenance
Correct Answer: Regulatory affairs and safety/pharmacovigilance
Q15. Which of the following is a lifecycle strategy to compete with incoming generics?
- Introduce authorized generics or reformulate for extended exclusivity
- Stop manufacturing immediately
- Remove safety warnings from labeling
- Decrease product stability to shorten shelf life
Correct Answer: Introduce authorized generics or reformulate for extended exclusivity
Q16. What role does stability testing play in PLCM?
- Determines expiry dating and storage conditions to support commercialization
- Is irrelevant after approval
- Only used for preclinical studies
- Replaces the need for pharmacovigilance
Correct Answer: Determines expiry dating and storage conditions to support commercialization
Q17. Which cost concept must be managed throughout the product life cycle to maintain profitability?
- Cost of goods sold (COGS) and lifecycle costing
- Petty cash only
- Facility depreciation exclusively
- Payroll for unrelated divisions
Correct Answer: Cost of goods sold (COGS) and lifecycle costing
Q18. Which regulatory activity is essential when making a post-approval change to drug formulation?
- Submit appropriate variation or supplement to regulatory authority
- Only inform marketing team verbally
- Change labeling without notifying authorities
- Stop stability testing permanently
Correct Answer: Submit appropriate variation or supplement to regulatory authority
Q19. Which factor most often triggers a recall during a product’s life cycle?
- New marketing campaign
- Quality or safety issues identified in production or post-marketing surveillance
- Patent renewal
- Successful phase III results
Correct Answer: Quality or safety issues identified in production or post-marketing surveillance
Q20. What is the importance of market access planning in PLCM for B.Pharm graduates?
- It ensures clinical trial randomization
- It aligns pricing, reimbursement and health technology assessment strategies for commercialization
- It replaces the need for quality control
- It focuses only on labelling font size
Correct Answer: It aligns pricing, reimbursement and health technology assessment strategies for commercialization
Q21. Which regulatory document monitors safety periodically after a product is marketed?
- Investigator’s Brochure
- Periodic Safety Update Report (PSUR) or Periodic Benefit-Risk Evaluation Report (PBRER)
- New Drug Application (NDA) only
- Certificate of Analysis for raw material
Correct Answer: Periodic Safety Update Report (PSUR) or Periodic Benefit-Risk Evaluation Report (PBRER)
Q22. In lifecycle management, what is portfolio optimization?
- Selecting and prioritizing products to maximize overall company value
- Discontinuing quality assurance activities
- Only focusing on the oldest product
- Centralizing all manufacturing to one obsolete site
Correct Answer: Selecting and prioritizing products to maximize overall company value
Q23. Which regulatory concept manages small, quality-related post-approval changes without full reapproval?
- Major line extension
- Post-approval change control and minor variation procedures
- Clinical hold
- IND submission
Correct Answer: Post-approval change control and minor variation procedures
Q24. What is the significance of expiration dating in PLCM?
- Determines when to stop clinical trials
- Specifies the shelf life to ensure safety and potency during distribution and use
- Is only a marketing term with no regulatory basis
- Dictates the number of marketing approvals required
Correct Answer: Specifies the shelf life to ensure safety and potency during distribution and use
Q25. Which practice helps maintain product quality during scale-up from lab to commercial manufacturing?
- Skipping process validation to save time
- Performing process validation and robust analytical method development
- Relying solely on visual inspection
- Removing in-process controls
Correct Answer: Performing process validation and robust analytical method development
Q26. Market exclusivity granted by regulatory agencies primarily affects which PLC aspect?
- Clinical trial design only
- Duration before generic competition can enter market
- Packaging design aesthetics
- Pharmacovigilance reporting frequency
Correct Answer: Duration before generic competition can enter market
Q27. Which is a common indicator of the growth stage for a pharmaceutical product?
- Decreasing R&D activities for the molecule
- Increasing prescriptions and expanding distribution
- Immediate removal from market
- Complete shift to over-the-counter without data
Correct Answer: Increasing prescriptions and expanding distribution
Q28. How does lifecycle data analytics support PLCM?
- By predicting demand, optimizing inventory and identifying safety trends
- By eliminating need for regulatory submissions
- By replacing laboratory stability studies
- By designing packaging only for aesthetics
Correct Answer: By predicting demand, optimizing inventory and identifying safety trends
Q29. Which action is part of responsible decommissioning when discontinuing a product?
- Immediate destruction of all documentation
- Ensuring supply continuity, notifying regulators, and managing remaining stock and patient safety
- Refusing to inform distributors
- Halting pharmacovigilance reporting permanently
Correct Answer: Ensuring supply continuity, notifying regulators, and managing remaining stock and patient safety
Q30. Why is cross-functional collaboration important in PLCM?
- Because single departments can manage the entire lifecycle alone
- It integrates R&D, manufacturing, regulatory, quality and commercial teams to ensure compliant and successful product management
- It delays decision-making intentionally
- It eliminates the need for regulatory filings
Correct Answer: It integrates R&D, manufacturing, regulatory, quality and commercial teams to ensure compliant and successful product management
I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.
Mail- Sachin@pharmacyfreak.com