Introduction: Effective storage and maintenance of raw material stores is essential for B. Pharm students to ensure drug quality, safety, and regulatory compliance. This topic covers key concepts such as Good Storage Practices (GSP), temperature and humidity control, quarantine and rejected material procedures, labeling, sampling, stability, shelf life, segregation of APIs and excipients, pest control, and documentation. Understanding storage mapping, data loggers, calibration, container compatibility, and controlled substance requirements helps prevent contamination, degradation, and cross-contamination. These skills support batch release decisions and audit readiness. Practical knowledge of storage conditions, SOPs, and regulatory expectations is critical for pharmaceutical manufacturing and quality assurance. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the primary purpose of placing incoming raw materials in a quarantine area?
- To store materials until needed for production
- To allow materials to acclimate to warehouse temperature
- To segregate materials pending sampling, testing, and release
- To reduce inventory space requirements
Correct Answer: To segregate materials pending sampling, testing, and release
Q2. Which temperature range is generally specified for refrigerated pharmaceutical raw materials?
- 8–15 °C
- 2–8 °C
- 15–25 °C
- −20 to −10 °C
Correct Answer: 2–8 °C
Q3. What is the main advantage of using first-expiry-first-out (FEFO) over FIFO in raw material handling?
- FEFO increases storage capacity
- FEFO reduces expiry-related rejections by using materials nearest expiry first
- FEFO is simpler to implement than FIFO
- FEFO eliminates the need for batch traceability
Correct Answer: FEFO reduces expiry-related rejections by using materials nearest expiry first
Q4. Which control is most effective for hygroscopic raw materials?
- Storing in direct sunlight
- Using open shelving
- Using desiccants and sealed containers with controlled low relative humidity
- Keeping at high humidity to prevent static
Correct Answer: Using desiccants and sealed containers with controlled low relative humidity
Q5. Which document provides safety, handling, and storage information for a chemical raw material?
- Certificate of Analysis (CoA)
- Stability protocol
- Safety Data Sheet (SDS)
- Batch production record
Correct Answer: Safety Data Sheet (SDS)
Q6. What is the purpose of temperature mapping in a warehouse?
- To identify ideal storage locations for aesthetic reasons
- To document temperature distribution and identify hot/cold spots for qualification
- To calibrate weighing balances
- To monitor employee productivity
Correct Answer: To document temperature distribution and identify hot/cold spots for qualification
Q7. Which practice best prevents cross-contamination between potent APIs and other materials?
- Storing potent APIs on the same shelf as excipients
- Segregation in separate locked rooms with dedicated equipment
- Mixing small amounts to dilute potency
- Labeling only the outer pallet
Correct Answer: Segregation in separate locked rooms with dedicated equipment
Q8. How often should temperature and humidity monitoring devices typically be calibrated for GMP storage areas?
- Naturally never required
- Only when an audit demands it
- At defined periodic intervals based on SOP, often annually or as specified
- Every 10 years
Correct Answer: At defined periodic intervals based on SOP, often annually or as specified
Q9. What is a reserve (retention) sample?
- A portion of the raw material retained for future testing in case of dispute
- A single-use sample for immediate production
- Material reserved for promotional use
- The entire received batch kept in cold storage
Correct Answer: A portion of the raw material retained for future testing in case of dispute
Q10. Which is a critical record to maintain for raw material receipt and issue?
- Employee vacation log
- Material receipt and issue log with batch number, quantity, and date
- Maintenance manual for forklifts
- Sales invoices for finished products
Correct Answer: Material receipt and issue log with batch number, quantity, and date
Q11. Which packaging is most suitable for light-sensitive raw materials?
- Clear polyethylene bags
- Amber glass or opaque, light-protective containers
- Open-top barrels
- Transparent PET bottles
Correct Answer: Amber glass or opaque, light-protective containers
Q12. What immediate action is required if stored raw material exceeds specified storage temperature during shipment?
- Use material without further checks
- Reject the material automatically and dispose
- Quarantine and perform risk assessment, testing, and possible investigation
- Relabel and put back into inventory
Correct Answer: Quarantine and perform risk assessment, testing, and possible investigation
Q13. Which regulatory principle directly applies to storage of pharmaceutical raw materials?
- Good Agricultural Practices (GAP)
- Good Manufacturing Practices (GMP)
- International Financial Reporting Standards (IFRS)
- Food Safety Modernization Act (FSMA)
Correct Answer: Good Manufacturing Practices (GMP)
Q14. What is the recommended action for rejected raw materials?
- Return to production after dilution
- Sell immediately to third parties
- Segregate, label as rejected, and follow documented disposition procedures
- Store with quarantine materials without labeling
Correct Answer: Segregate, label as rejected, and follow documented disposition procedures
Q15. Which environmental factor most accelerates chemical degradation of many APIs?
- Low oxygen environment
- High humidity and elevated temperature
- Stable, low temperature
- High vacuum packaging
Correct Answer: High humidity and elevated temperature
Q16. What is the role of a batch number on raw material labels?
- To indicate supplier price
- To enable traceability and identification for quality control and recalls
- To show the weight of the container
- To mark storage shelf location
Correct Answer: To enable traceability and identification for quality control and recalls
Q17. For flammable solvent storage, which is the most appropriate precaution?
- Store near heat sources for faster evaporation
- Use explosion-proof cabinets with proper ventilation and grounding
- Keep in open pallets on the warehouse floor
- Store in direct sunlight to avoid condensation
Correct Answer: Use explosion-proof cabinets with proper ventilation and grounding
Q18. Which sampling practice is compliant with GMP for raw material acceptance?
- Random sampling without SOPs
- Sampling per approved SOP with defined method, sample size, and lot representativeness
- Using visual inspection only
- Taking samples from only the top layer of the container
Correct Answer: Sampling per approved SOP with defined method, sample size, and lot representativeness
Q19. What is a common corrective action when a data logger in a cold store fails?
- Ignore the failure if visual checks look okay
- Immediately investigate, repair/replace device, review temperature records, and assess impact on stored materials
- Discard all materials immediately
- Turn off the alarm permanently
Correct Answer: Immediately investigate, repair/replace device, review temperature records, and assess impact on stored materials
Q20. Which practice is important for pesticide/pest control in raw material stores?
- Use unrestricted pesticide spraying near open materials
- Implement integrated pest management, regular inspections, and non-chemical controls where possible
- Ignore pests unless evident in finished products
- Store food in the same area to distract pests
Correct Answer: Implement integrated pest management, regular inspections, and non-chemical controls where possible
Q21. What is the significance of a Certificate of Analysis (CoA) for incoming materials?
- It is a marketing brochure from the supplier
- It provides supplier batch test results to support release decisions after verification
- It replaces the need for in-house testing
- It is only used for finished products
Correct Answer: It provides supplier batch test results to support release decisions after verification
Q22. Which is the best practice when storing incompatible chemicals?
- Store all chemicals together to save space
- Segregate incompatible chemicals and follow compatibility charts and SDS guidance
- Always neutralize chemicals before storage
- Label incompatibility but keep items adjacent
Correct Answer: Segregate incompatible chemicals and follow compatibility charts and SDS guidance
Q23. What is the purpose of retention period for raw material records in GMP?
- To meet legal, regulatory, and quality requirements for traceability and investigations
- To make warehouse audits longer
- To eliminate the need for current documentation
- To increase storage costs intentionally
Correct Answer: To meet legal, regulatory, and quality requirements for traceability and investigations
Q24. Which of the following best describes “controlled room temperature” for many pharmaceutical materials?
- 50–60 °C
- 15–25 °C with allowed excursions as defined by policy
- 0–5 °C exactly
- Any temperature below ambient
Correct Answer: 15–25 °C with allowed excursions as defined by policy
Q25. Why are sample retention containers stored under the same conditions as the bulk material?
- To save energy
- To ensure sample stability reflects the stored material and supports future testing
- To make sample handling easier
- To encourage faster degradation
Correct Answer: To ensure sample stability reflects the stored material and supports future testing
Q26. How should controlled substances and scheduled drugs be stored in a pharmaceutical facility?
- With general consumables
- In secure, access-controlled areas with strict inventory and reconciliation procedures
- Unlocked for quick access by all staff
- Stored off-site without documentation
Correct Answer: In secure, access-controlled areas with strict inventory and reconciliation procedures
Q27. What does material reconciliation help to detect?
- Only packaging defects
- Discrepancies between recorded and actual inventory indicating loss, theft, or process issues
- The aesthetic appearance of raw materials
- Supplier marketing updates
Correct Answer: Discrepancies between recorded and actual inventory indicating loss, theft, or process issues
Q28. Which action is essential before returning a returned raw material to inventory?
- Place it directly on the shelf by date
- Quarantine and evaluate for condition, contamination, and authorized disposition per SOP
- Mix it with new material
- Relabel with a new batch number
Correct Answer: Quarantine and evaluate for condition, contamination, and authorized disposition per SOP
Q29. Which factor is least likely to be evaluated during a storage area audit?
- Effectiveness of pest control measures
- Availability of adequate lighting for packing aesthetics
- Accuracy of environmental monitoring records
- Proper labeling and segregation of materials
Correct Answer: Availability of adequate lighting for packing aesthetics
Q30. What is the correct approach for handling partial containers of raw material opened during sampling?
- Leave them open for faster reuse
- Seal and label with updated batch, opening date/time, and storage conditions per SOP
- Discard immediately regardless of quantity
- Transfer contents to a different unlabeled container
Correct Answer: Seal and label with updated batch, opening date/time, and storage conditions per SOP
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