Legal requirements and licenses for API industry MCQs With Answer

Introduction

This quiz collection focuses on the legal requirements and licensing framework for the Active Pharmaceutical Ingredient (API) industry, designed specifically for M.Pharm students. It covers national and international regulatory expectations, key regulatory documents (DMF, CEP, CPP), GMP and validation requirements, environmental and controlled-substance permits, and commercial/export obligations. The questions test conceptual understanding and practical compliance knowledge essential for API development, manufacturing, quality assurance and regulatory affairs. Use these MCQs to reinforce your familiarity with regulatory bodies, dossier components, quality systems and licensing pathways that govern safe and legal API production and distribution.

Q1. Which central authority in India is primarily responsible for approval of new drugs, import licensing and national-level drug regulations?

• State Drug Licensing Authority
• Central Drugs Standard Control Organization (CDSCO)
• Pharmaceuticals Export Promotion Council (Pharmexcil)
• Ministry of Environment, Forest and Climate Change

Correct Answer: Central Drugs Standard Control Organization (CDSCO)

Q2. For routine commercial manufacture of APIs within an Indian state, which body issues the manufacturing license?

• Central Drugs Standard Control Organization (CDSCO)
• State Drug Licensing Authority (State FDA)
• Drug Controller General of India (DCGI) separately for each factory
• Ministry of Commerce

Correct Answer: State Drug Licensing Authority (State FDA)

Q3. What is the primary purpose of a Drug Master File (DMF)?

• To provide confidential manufacturing and quality information of an API to regulatory authorities and applicants
• To certify environmental compliance for API manufacture
• To document clinical trial results for the finished product
• To replace the manufacturing license for export

Correct Answer: To provide confidential manufacturing and quality information of an API to regulatory authorities and applicants

Q4. Which international document specifically provides GMP guidance for the manufacture of active pharmaceutical ingredients?

• ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
• ICH Q1A: Stability Testing of New Drug Substances and Products
• WHO TRS Annex: Quality Risk Management only
• ISO 9001: Quality Management Systems for APIs

Correct Answer: ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

Q5. What does a Certificate of Suitability (CEP) issued by EDQM demonstrate for an API?

• Conformity of the substance with the European Pharmacopoeia monograph
• Environmental clearance for API manufacturing
• Approval to market the finished drug product in Europe
• Authorization to export without further documentation

Correct Answer: Conformity of the substance with the European Pharmacopoeia monograph

Q6. Which document is typically requested by importing regulatory authorities to demonstrate product authorization in the exporting country?

• Certificate of Pharmaceutical Product (CPP)
• Manufacturing Purchase Order
• Quality Agreement only
• Environmental Impact Assessment

Correct Answer: Certificate of Pharmaceutical Product (CPP)

Q7. What environmental permission is commonly required before establishing an API manufacturing facility in India?

• Consent to Establish and Consent to Operate from the State Pollution Control Board (SPCB)
• Certificate of Pharmaceutical Product (CPP)
• Export Import Code (IEC) from Customs
• No environmental permissions are required

Correct Answer: Consent to Establish and Consent to Operate from the State Pollution Control Board (SPCB)

Q8. Which of the following best describes the role of a Quality Agreement between an API manufacturer and its customer?

• It defines roles, responsibilities, testing, release and change control activities between manufacturer and buyer
• It is a financial contract for pricing and delivery dates only
• It substitutes for regulatory inspections by authorities
• It provides environmental compliance information

Correct Answer: It defines roles, responsibilities, testing, release and change control activities between manufacturer and buyer

Q9. For import of APIs into India for local sale, which license is generally required?

• Import license (or permission) issued by CDSCO
• State manufacturing license
• Factory license from the Labour Department only
• No license is needed for APIs

Correct Answer: Import license (or permission) issued by CDSCO

Q10. Which regulatory dossier element specifically addresses limits and control of impurities, including potential genotoxic impurities, for an API?

• Specification and impurity profile with validated analytical methods
• Factory layout drawing only
• Packaging material supplier list
• Employee training records only

Correct Answer: Specification and impurity profile with validated analytical methods

Q11. The ALCOA principles in good documentation practices stand for which of the following sets of attributes?

• Attributable, Legible, Contemporaneous, Original, Accurate
• Available, Logged, Copied, Organized, Archived
• Approved, Listed, Checked, Operated, Archived
• Accessible, Legal, Complete, Omitted, Accountable

Correct Answer: Attributable, Legible, Contemporaneous, Original, Accurate

Q12. Which regulatory requirement is most directly used to set shelf-life and storage conditions for an API product?

• Stability study data generated per ICH or regional guidelines
• Batch manufacturing date alone
• Customer preference on storage
• Manufacturer’s financial year

Correct Answer: Stability study data generated per ICH or regional guidelines

Q13. Which Indian law governs the control and licensing of narcotic and psychotropic substances relevant to APIs that are controlled?

• Narcotic Drugs and Psychotropic Substances (NDPS) Act
• Companies Act
• Factory Act only
• Foreign Exchange Management Act (FEMA)

Correct Answer: Narcotic Drugs and Psychotropic Substances (NDPS) Act

Q14. For export to many regulated markets, an API manufacturer is commonly expected to hold which of the following documents?

• GMP certificate issued by the competent national authority and/or a DMF/CEP
• Only a State trade license
• Only local municipal tax receipts
• No documents are required for export

Correct Answer: GMP certificate issued by the competent national authority and/or a DMF/CEP

Q15. Process validation in API manufacture primarily demonstrates what?

• That the process consistently produces material meeting predetermined specifications and quality attributes
• That the manufacturing site has electricity backup
• Proof of cost-effectiveness of the process
• Only that analytical methods are validated

Correct Answer: That the process consistently produces material meeting predetermined specifications and quality attributes

Q16. Which of the following is commonly required to manage hazardous chemical waste from an API plant?

• Authorization and compliance with the State Pollution Control Board and hazardous waste rules
• Only internal housekeeping procedures
• ISO 27001 certification
• No special management is necessary

Correct Answer: Authorization and compliance with the State Pollution Control Board and hazardous waste rules

Q17. Which of the following items would NOT normally be part of an API regulatory dossier submitted for registration?

• Employee payroll records unrelated to quality functions
• Manufacturing process description
• Analytical methods and validation data
• Specification and stability data

Correct Answer: Employee payroll records unrelated to quality functions

Q18. Which international certificate specifically helps demonstrate that an API manufacturer’s quality system complies with European requirements for monograph conformity?

• Certificate of Suitability (CEP) from EDQM
• ISO 14001 Environmental Certificate
• FDA Establishment Registration only
• Local municipal business license

Correct Answer: Certificate of Suitability (CEP) from EDQM

Q19. Which practice helps ensure regulatory readiness and quick response during authority inspections?

• Maintaining up-to-date, organized records, change control documentation and periodic internal audits
• Only keeping verbal knowledge with senior staff
• Storing documents in personal laptops without backups
• Delaying corrective actions until after inspection

Correct Answer: Maintaining up-to-date, organized records, change control documentation and periodic internal audits

Q20. What are potential legal consequences of manufacturing APIs without the required drug manufacturing license?

• Regulatory action including seizure of product, fines, prosecution and shutdown of operations
• Automatic granting of retrospective license without inspection
• Only a warning letter with no further action
• Permission to sell in local markets without restrictions

Correct Answer: Regulatory action including seizure of product, fines, prosecution and shutdown of operations

Download