Storage and handling procedures for finished goods and raw materials are essential topics for B.Pharm students, linking pharmaceutical quality, safety, and regulatory compliance. This introduction covers key concepts such as temperature and humidity control, segregation of quarantined and rejected lots, traceability and labeling, First Expiry First Out (FEFO) and FIFO inventory systems, cold chain and controlled room storage, environmental monitoring, packaging and contamination prevention, documentation and batch records, pest control, and Good Manufacturing/Distribution Practices (GMP/GDP). Understanding these procedures ensures product stability, prevents mix-ups and recalls, and maintains patient safety across the supply chain. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. Which inventory method prioritizes dispatch based on earliest expiration date to minimize product expiry?
- First In First Out (FIFO)
- Last In First Out (LIFO)
- First Expiry First Out (FEFO)
- Just-In-Time (JIT)
Correct Answer: First Expiry First Out (FEFO)
Q2. Which of the following is a regulatory requirement specifically related to storage and distribution of pharmaceutical products?
- Good Laboratory Practice (GLP)
- Good Manufacturing Practice (GMP)
- Good Distribution Practice (GDP)
- Good Clinical Practice (GCP)
Correct Answer: Good Distribution Practice (GDP)
Q3. What is the primary purpose of environmental monitoring in storage areas?
- To improve packaging aesthetics
- To measure temperature only
- To detect and control contamination risks such as microbial load, dust, and humidity
- To reduce inventory turnover
Correct Answer: To detect and control contamination risks such as microbial load, dust, and humidity
Q4. Which record is essential to demonstrate that a cold chain was maintained during storage and transport?
- Material Safety Data Sheet (MSDS)
- Temperature log with calibrated data loggers
- Purchase order
- Billing invoice
Correct Answer: Temperature log with calibrated data loggers
Q5. In a pharmaceutical warehouse, quarantined raw materials should be:
- Stored together with released materials for convenience
- Segregated and clearly labeled pending quality testing
- Used immediately to avoid wastage
- Sent to production without documentation
Correct Answer: Segregated and clearly labeled pending quality testing
Q6. Which of the following is a key element of Good Storage Practices (GSP)?
- Ignoring labeling once stored
- Regular pest control, temperature control, and recorded inspections
- Mixing different classes of hazardous and non-hazardous goods randomly
- Allowing unrestricted access to all staff
Correct Answer: Regular pest control, temperature control, and recorded inspections
Q7. What is the correct action when a lot is identified as suspected contaminated during incoming inspection?
- Place it in quarantine and initiate investigation
- Return it to the supplier immediately without documentation
- Store it on the top shelf with other released lots
- Use it in production to meet deadlines
Correct Answer: Place it in quarantine and initiate investigation
Q8. Which storage parameter most directly affects hydrolytic degradation of moisture-sensitive drugs?
- Lighting intensity
- Humidity control
- Floor load capacity
- Inventory rotation method
Correct Answer: Humidity control
Q9. What documentation is critical to ensure traceability of finished goods from production to dispatch?
- Certificate of Analysis only
- Batch records, shipping records, and inventory ledgers
- Only the packing slip
- Only the supplier invoice
Correct Answer: Batch records, shipping records, and inventory ledgers
Q10. For highly temperature-sensitive vaccines, what storage practice is essential?
- Store at ambient room temperature
- Maintain validated cold chain with temperature monitoring and alarm systems
- Freeze all vaccines to be safe
- Store them with other frozen food items
Correct Answer: Maintain validated cold chain with temperature monitoring and alarm systems
Q11. Which is the most appropriate way to store flammable solvents in a pharmaceutical warehouse?
- On open wooden pallets near exits
- In approved flammable storage cabinets with proper bonding and grounding
- Next to oxidizing agents to save space
- Under direct sunlight to evaporate vapors
Correct Answer: In approved flammable storage cabinets with proper bonding and grounding
Q12. What does the acronym MSDS (or SDS) stand for and why is it important in handling materials?
- Manufacturing Standard Data Sheet; used for batch sizing
- Material Safety Data Sheet (Safety Data Sheet); provides hazard, handling, and emergency information
- Material Stock Data Summary; used for inventory count only
- Manufacturing Safety Design Sheet; used for plant layout
Correct Answer: Material Safety Data Sheet (Safety Data Sheet); provides hazard, handling, and emergency information
Q13. Which practice helps prevent cross-contamination between different drug products in storage?
- Storing similar-looking products together to save space
- Segregation by product family, dedicated shelving, and clear labeling
- Mixing returned goods with released stock
- Using only color codes without labels
Correct Answer: Segregation by product family, dedicated shelving, and clear labeling
Q14. Why is calibration of temperature and humidity monitoring devices important in pharmaceutical storage?
- To enhance the appearance of documentation
- To ensure accurate environmental data for compliance and product stability
- To allow manual approximation of conditions
- To avoid having to replace sensors
Correct Answer: To ensure accurate environmental data for compliance and product stability
Q15. What is a key control for handling returned finished goods to prevent reintroduction of compromised products?
- Place them back on shelf immediately to minimize losses
- Quarantine returns, inspect, document, and decide disposition based on quality assessment
- Destroy all returns without assessment
- Resell returns without testing to recover costs
Correct Answer: Quarantine returns, inspect, document, and decide disposition based on quality assessment
Q16. Which factor is least relevant when designing storage for pharmaceutical raw materials?
- Compatibility and segregation requirements
- Ambient temperature and humidity control needs
- Proximity to canteen area for staff convenience
- Security and restricted access
Correct Answer: Proximity to canteen area for staff convenience
Q17. What is the correct labeling requirement for rejected or retained samples in a warehouse?
- No label is required if kept separately
- Clear identification as “Rejected” or “Retained” with date, batch number, and reason
- Only a handwritten note by any staff member
- Label as “For Use” to avoid confusion
Correct Answer: Clear identification as “Rejected” or “Retained” with date, batch number, and reason
Q18. How often should pest control measures and inspections be documented in a pharmaceutical storage facility?
- Never documented; only done ad hoc
- Regularly, according to facility SOPs with dated records and corrective actions
- Only when pests are seen
- Only during regulatory inspections
Correct Answer: Regularly, according to facility SOPs with dated records and corrective actions
Q19. Which practice improves traceability in the event of a product recall?
- Randomly mixing batch numbers during packing
- Maintaining complete batch-wise records, serial numbers, and shipment logs
- Destroying old shipping documents monthly
- Not recording which batches were dispatched
Correct Answer: Maintaining complete batch-wise records, serial numbers, and shipment logs
Q20. Which is a common cause of degradation for light-sensitive pharmaceutical products in storage?
- Exposure to high humidity only
- Exposure to ultraviolet and visible light due to inadequate light protection
- Low inventory turnover
- Excessive cold storage below specified ranges only
Correct Answer: Exposure to ultraviolet and visible light due to inadequate light protection
Q21. What must be included in the procedure for sampling raw materials from storage?
- Random sampling without documentation
- A documented sampling plan, representative technique, sample size, and chain-of-custody record
- Only the quality manager’s verbal approval
- Sampling only from the surface of pallets to save time
Correct Answer: A documented sampling plan, representative technique, sample size, and chain-of-custody record
Q22. Which of the following is NOT an element of a validated cold chain for finished pharmaceuticals?
- Calibrated temperature-controlled storage and transport units
- Temperature excursion handling procedures
- Unrecorded manual temperature checks once a month
- Continuous monitoring and alarm systems
Correct Answer: Unrecorded manual temperature checks once a month
Q23. How should hazardous pharmaceutical waste be handled in storage areas?
- Mixed with general waste for convenience
- Stored in designated, labeled containers and disposed following regulations
- Left in production areas indefinitely
- Sold as raw material to third parties
Correct Answer: Stored in designated, labeled containers and disposed following regulations
Q24. Which control reduces risk of mix-ups during order picking in a warehouse?
- Single-person operations without checks
- Use of barcode/RFID verification and double-check procedures
- Blind picking based on memory
- Removing labels from packages to simplify handling
Correct Answer: Use of barcode/RFID verification and double-check procedures
Q25. What is the role of packaging in maintaining storage stability of finished pharmaceutical products?
- Packaging is only for marketing and has no stability role
- Proper packaging provides physical protection, barrier to moisture/light, and labeling for storage conditions
- Packaging should always be minimal to reduce cost regardless of stability needs
- Packaging replaces the need for controlled storage conditions
Correct Answer: Proper packaging provides physical protection, barrier to moisture/light, and labeling for storage conditions
Q26. When should a warehouse conduct a temperature excursion investigation?
- Only if a regulatory inspector asks
- Whenever recorded temperatures fall outside validated limits
- Only for excursions lasting more than a year
- Excursions need not be investigated if products appear normal
Correct Answer: Whenever recorded temperatures fall outside validated limits
Q27. Why is training of warehouse personnel important in pharmaceutical storage?
- Training is optional and only for managerial staff
- Training ensures correct handling, documentation, hygiene, emergency response, and regulatory compliance
- Training replaces the need for SOPs
- Training is only required for drivers
Correct Answer: Training ensures correct handling, documentation, hygiene, emergency response, and regulatory compliance
Q28. Which of the following best describes “access control” in a pharmaceutical storage facility?
- Allowing unrestricted access to all storage zones
- Implementing controlled entry, visitor logs, and role-based access to sensitive areas
- Only locking the main gate at night
- Relying on verbal authorization for entry
Correct Answer: Implementing controlled entry, visitor logs, and role-based access to sensitive areas
Q29. What is the significance of lot segregation in storage of APIs and excipients?
- It is unnecessary if labels are present
- Prevents cross-contamination, mix-ups, and ensures traceability of each lot
- It increases handling time without benefits
- Segregation is only for finished goods, not raw materials
Correct Answer: Prevents cross-contamination, mix-ups, and ensures traceability of each lot
Q30. Which approach is recommended for handling suspected counterfeit or tampered finished products found in store?
- Return them to stock to avoid losses
- Quarantine, inform quality/regulatory unit, preserve evidence, and notify authorities if required
- Destroy them immediately without documentation
- Mix them with waste without record
Correct Answer: Quarantine, inform quality/regulatory unit, preserve evidence, and notify authorities if required
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