Loan license and repacking license MCQs With Answer

Loan license and repacking license MCQs With Answer

This concise introduction explains key concepts of loan license and repacking license for B. Pharm students, focusing on regulatory compliance, Good Manufacturing Practices (GMP), labeling, quality control, documentation and responsibilities under the Drugs and Cosmetics framework. Learn how loan licensing enables manufacturing or packing of finished products at another licensed premises, while repacking covers reshaping or relabeling of already manufactured dosage forms. Emphasis is placed on roles of the licensing authority, mandatory agreements, record keeping, inspection, sample retention and product safety. These keywords—loan license, repacking license, GMP, labeling, quality control, regulatory compliance, CDSCO, State Licensing Authority—will guide deeper regulatory understanding. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is a loan license in pharmaceutical practice?

• Permission allowing one licensee to use another licensed premises to manufacture or pack products on behalf of the license holder
• Temporary export permit for finished products
• Approval to import raw materials for manufacturing
• License to sell drugs directly to consumers

Correct Answer: Permission allowing one licensee to use another licensed premises to manufacture or pack products on behalf of the license holder

Q2. What activity does a repacking license specifically permit?

• Manufacture of active pharmaceutical ingredients (APIs)
• Repackaging or relabeling of already manufactured finished dosage forms for distribution
• Clinical trial conduct for new drugs
• Import of controlled substances

Correct Answer: Repackaging or relabeling of already manufactured finished dosage forms for distribution

Q3. Which authority typically issues manufacturing, loan and repacking licenses in India?

• State Licensing Authority
• World Health Organization (WHO)
• Food and Agriculture Organization (FAO)
• Local municipal corporation

Correct Answer: State Licensing Authority

Q4. Under which primary legislation are loan and repacking licenses governed in India?

• Food Safety and Standards Act
• Drugs and Cosmetics Act, 1940
• Indian Penal Code
• Pharmacy Act

Correct Answer: Drugs and Cosmetics Act, 1940

Q5. Which statement best distinguishes loan license from contract manufacturing?

• Loan license allows production at another licensee’s premises under a formal arrangement; contract manufacturing typically involves outsourcing production to a third-party manufacturer under a commercial contract
• Loan license is only for exports while contract manufacturing is for domestic sales
• Contract manufacturing does not require any license
• Loan license permits clinical trials at manufacturing sites

Correct Answer: Loan license allows production at another licensee’s premises under a formal arrangement; contract manufacturing typically involves outsourcing production to a third-party manufacturer under a commercial contract

Q6. Which document is essential when applying for a loan license?

• Manufacturing agreement or contract between the two licensees
• Patent transfer deed
• Export-import code only
• Clinical trial approval

Correct Answer: Manufacturing agreement or contract between the two licensees

Q7. Who holds primary legal responsibility for product quality in a loan license arrangement?

• Both the loan license holder and the licensee whose premises are used share responsibility
• Only the loan license holder
• Only the premises owner
• Only the distributor

Correct Answer: Both the loan license holder and the licensee whose premises are used share responsibility

Q8. Which of the following is a core GMP requirement relevant to repacking and loan licensing?

• Adequate premises, validated processes, trained personnel and quality control procedures
• Free distribution of samples to consumers
• No record keeping of batches
• Unlimited transfer of license without approval

Correct Answer: Adequate premises, validated processes, trained personnel and quality control procedures

Q9. What labeling information is mandatory for products manufactured under a loan license?

• Name and address of the manufacturing premises, batch number, manufacturing and expiry dates and license details as required by regulations
• Only the marketing company’s logo
• Price and distributor name only
• No labeling is required for loan-manufactured products

Correct Answer: Name and address of the manufacturing premises, batch number, manufacturing and expiry dates and license details as required by regulations

Q10. Which record is particularly important to maintain in both loan licensing and repacking operations?

• Batch manufacturing and packing records with traceability to raw materials and finished products
• Only sales invoices with no production details
• Employee personal diaries
• Advertising plans

Correct Answer: Batch manufacturing and packing records with traceability to raw materials and finished products

Q11. When repacking a product into new primary packaging, what must be evaluated?

• Impact on stability, shelf life and product integrity with appropriate validation studies
• Only the color of the new package
• Whether the distributor prefers the new package
• No evaluation is required for finished products

Correct Answer: Impact on stability, shelf life and product integrity with appropriate validation studies

Q12. Which of the following can trigger an inspection by the licensing authority?

• Routine surveillance, complaint, change in manufacturing arrangements or suspicion of non-compliance
• Only when a company requests an export license
• Inspections never occur for repackers
• Only after ten years of operation

Correct Answer: Routine surveillance, complaint, change in manufacturing arrangements or suspicion of non-compliance

Q13. For a repacking operation, which personnel requirement is essential?

• Trained personnel familiar with aseptic techniques when applicable and packaging validation
• Only accounting staff
• No training is required
• Personnel only need marketing experience

Correct Answer: Trained personnel familiar with aseptic techniques when applicable and packaging validation

Q14. How should retained samples be managed in loan license arrangements?

• Representative retained samples of finished batches should be stored under specified conditions for the period required by regulations
• Samples must be discarded immediately
• Samples should be sold to distributors
• No samples are necessary for repacked items

Correct Answer: Representative retained samples of finished batches should be stored under specified conditions for the period required by regulations

Q15. Which Schedule in Indian regulations primarily deals with Good Manufacturing Practices for drugs?

• Schedule M
• Schedule X
• Schedule Y
• Schedule J

Correct Answer: Schedule M

Q16. Who is normally responsible for pharmacovigilance and adverse drug reaction reporting when a product is manufactured under loan license?

• Both the marketing (loan license) firm and the manufacturer share responsibilities, with the marketing authorization holder having primary pharmacovigilance obligations
• The distributor only
• The packaging supplier only
• No pharmacovigilance is needed for repacked products

Correct Answer: Both the marketing (loan license) firm and the manufacturer share responsibilities, with the marketing authorization holder having primary pharmacovigilance obligations

Q17. Which activity would typically require a separate repacking license?

• Repacking bulk finished tablets into consumer packs with a change in pack size or label
• Simple transfer of paperwork between offices
• Storage of finished goods in a bonded warehouse without repacking
• Sales promotion events

Correct Answer: Repacking bulk finished tablets into consumer packs with a change in pack size or label

Q18. What is a common regulatory consequence of operating repacking or loan manufacturing without proper license?

• License cancellation, monetary penalties and possible prosecution
• Automatic renewal of license
• Awards and recognition
• Immediate patent approval

Correct Answer: License cancellation, monetary penalties and possible prosecution

Q19. In a loan licensing arrangement, which party’s name typically appears on the product label as the marketing authorization holder?

• The loan license holder or marketing authorization holder whose product is being manufactured or packed
• The premises owner only
• The raw material supplier
• The courier service used for distribution

Correct Answer: The loan license holder or marketing authorization holder whose product is being manufactured or packed

Q20. Which factor is critical when repacking sterile parenteral products?

• Aseptic processing environments, validated sterile procedures and sterility assurance
• Only one-year shelf life
• Color of the outer carton
• Lowering supplier invoices

Correct Answer: Aseptic processing environments, validated sterile procedures and sterility assurance

Q21. Which of the following best describes relabeling as distinct from repacking?

• Relabeling changes or updates label information on the existing container without changing primary packaging; repacking changes the primary container or pack size
• Relabeling is illegal in all circumstances
• Repacking only changes the chemical composition of the drug
• Relabeling always increases product potency

Correct Answer: Relabeling changes or updates label information on the existing container without changing primary packaging; repacking changes the primary container or pack size

Q22. Which one is NOT typically included in a loan license agreement?

• Agreement to transfer ownership title of the original manufacturer’s license permanently
• Details of responsibilities for quality control and batch records
• Terms for supply of raw materials and finished goods handling
• Liability clauses and duration of the arrangement

Correct Answer: Agreement to transfer ownership title of the original manufacturer’s license permanently

Q23. For repacking, why is validation of the packing process necessary?

• To ensure reproducibility, packaging integrity, correct labeling and maintenance of product quality
• Only to reduce labor costs
• Validation is optional and not scientifically important
• To increase the product price arbitrarily

Correct Answer: To ensure reproducibility, packaging integrity, correct labeling and maintenance of product quality

Q24. Which practice improves traceability in loan license and repacking operations?

• Maintaining batch numbers, raw material lot references and full batch records linking inward and outward movement
• Using generic labels with no batch numbers
• Destroying production records monthly
• Not documenting any manufacturing dates

Correct Answer: Maintaining batch numbers, raw material lot references and full batch records linking inward and outward movement

Q25. What should be done if repacking changes packaging that might affect product shelf-life?

• Conduct stability studies or provide supportive data to justify shelf-life under new packaging conditions
• Immediately double the labeled expiry date without testing
• Remove the expiry date from the label
• Only change the outer carton color

Correct Answer: Conduct stability studies or provide supportive data to justify shelf-life under new packaging conditions

Q26. Are manufacturing licenses generally transferable from one company to another?

• No, manufacturing and related licenses are generally non-transferable without prior approval from the licensing authority
• Yes, licenses can be transferred freely without any approval
• Licenses transfer automatically on sale of any asset
• Transfer is only possible through international bodies

Correct Answer: No, manufacturing and related licenses are generally non-transferable without prior approval from the licensing authority

Q27. Which routine practice reduces risk of cross-contamination during repacking?

• Dedicated areas, proper cleaning procedures and controlled material flow
• Mixing different products in the same line without cleaning
• Allowing free movement between warehouses and production floor
• Using unlabelled containers for all products

Correct Answer: Dedicated areas, proper cleaning procedures and controlled material flow

Q28. Which of the following is the first step when applying for a loan or repacking license?

• Submission of an application with required supporting documents to the licensing authority
• Immediate start of production without approval
• Publishing advertisements about the new product
• Signing a distribution agreement only

Correct Answer: Submission of an application with required supporting documents to the licensing authority

Q29. What is an essential label statement for repacked medicinal products?

• Clear indication of the name/identity of the product, batch number, manufacturing/packing date, expiry date and name of the repacker or manufacturer as required
• Only the price and barcode
• Manufacturer’s secret code only
• Distributor’s phone number only

Correct Answer: Clear indication of the name/identity of the product, batch number, manufacturing/packing date, expiry date and name of the repacker or manufacturer as required

Q30. What is a primary objective of having loan license and repacking regulations?

• To protect public health by ensuring that outsourced manufacturing and repacking maintain product quality, safety, traceability and regulatory compliance
• To create unnecessary paperwork for companies
• To restrict market access for small firms only
• To eliminate the need for quality control laboratories

Correct Answer: To protect public health by ensuring that outsourced manufacturing and repacking maintain product quality, safety, traceability and regulatory compliance

G S Sachin

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