Class: 4th year B. Pharm.
Semester-VII
Subject: Industrial Pharmacy-II (BP702T) Unit Wise Questions Bank
Unit-01
2 MARKS Questions
1. Define pilot and scale up?
2. What is the difference between pilot scale and scale-up?
3. Why to conduct pilot plant studies?
4. What are the advantages of pilot studies?
5. What is SUPAC?
6. What is the purpose of SUPAC guidelines?
7. Define platform technology?
5 MARKS short Questions
1. What are the objectives and significance of pilot plants?
2. Explain SUPAC guidelines?
3. Discuss the uses of platform technology?
10 MARKS Long Question
1. Discuss the general factors to be considered in pilot plant scale up technology?
2. Discuss pilot plant scale up consideration for solids dosage solids.
3. Discuss pilot plant scale up consideration for liquid orals.
4. Discuss pilot plant scale up consideration for semi-solids.
5. What are difference platform technology and explain.
Unit-02
02 MARKS Questions
1. Define the technology transfer according to WHO and how it is classified?
2. What is the goal and advantages of technology transfer?
3. What are good manufacturing practices (GMP)?
4. What do you mean by SU & RU
5. Define quality risk management (QRM) and write its principle
6. What do you mean by intercompany and intracompany?
7. What is standard operating procedure (SOP)?
8. What is validation and process validation?
9. What is validation protocol (VP) and validation report (VR)?
10. What is the drug master file (DMF)?
11. What is analytical method transfer?
12. What is design qualification (DQ) and installation qualification (IQ)?
13. What is operational qualification (OQ) and performance qualification (PQ)?
05 MARKS short Questions
1. Explain technology transfer sample protocol in pharmaceuticals
2. Discuss technology transfer from R & D to production as per WHO guidelines?
3. Discuss granularity of TT process (API, excipients, finished products, packaging material)
as per WHO guidelines for TT?
4. Discuss about documentation, premises, and equipments for TT as per WHO guidelines
5. Discuss about qualification and validation for TT as per WHO guidelines?
6. How analytical methods are exchanged in a technology transfer?
10 MARKS Long Question
1. Discuss stage involved in TT in pharmaceutical industry?
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Class: 4th year B. Pharm. Semester-VII
Subject: Industrial Pharmacy-II (BP702T) Unit Wise Questions Bank
Unit-03
02 MARKS Questions
1. What is a regulatory affair? What its goal?
2. What is investigational new drug and application?
3. What is New Drug Application (NDA)?
4. What is clinical trial?
5. What is clinical trial protocol?
6. What are BE & BA studies? Why they are required?
7. Mention the major regulatory bodies in the world?
8. What is the organizational structure of regulatory affairs?
9. Which is the health care product regulated by RA?
10. What is CTD?
05 MARKS short Questions
1. Discuss the role and responsibilities of RA professional.
2. Write a note on Drug development team and their functions.
3. Discuss regulatory authorities and their responsibilities.
4. Write a note on Non-clinical drug development process.
5. Write a note on Investigator’s Brochure (IB).
6. Discuss the different phase of clinical trial.
7. How Bioequivalence are documented.
8. Write a note on clinical Research protocol.
9. Discuss about Management of clinical studies.
10. Discuss the various Modules in CTD.
10 MARKS Long Questions
1. Explain Regulatory Requirement Approval for obtaining NDA.
2. Discuss general consideration of Investigational New drug Application.
Unit-04
02 MARKS Questions
1. Define Total, Quality, Total Quality and Total Quality Management.
2. What are the advantages and disadvantages of TQM?
3. What is the mission of NABL?
4. Mention the advantages of QbD.
5. Define clinical trials and write its importance.
6. What is zero-defect product?
7. What are the objectives of GLP
05 MARKS short Questions
1. Write a note on QBD.
2. Explain Out of Specification (OOS)
3. Write a note on Change Control.
4. Write a note on NABL and GLP.
10 MARKS Long Questions
1. Discuss Six Sigma.
2. Explain ISO9000.
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Class: 4th year B. Pharm. Semester-VII
Subject: Industrial Pharmacy-II (BP702T) Unit Wise Questions Bank
Unit-05
02 MARKS Questions
1. Define DRA.
2. What are the functions of regulatory authority?
3. What is the vision and mission of CDSCO?
4. Write two advantages of the COPP scheme.
5. Write two functions of State Drug Regulatory Authorities (SDRAs)
6. Define standard deviation.
7. What are the Types of COPP.
8. Two functions of Port Offices of CDSCO
9. Write the types of drugs for which COPPs may be issued.
05 MARKS short Questions
1. What is CDSCO? What are the different functions of CDSCO?
2. Write a note on Central Drugs Testing Laboratories (CDTL).
3. Describe the Organization of CDSCO with flow diagram.
4. Describe the WHO Certification Scheme for a Certificate of Pharmaceutical Product
(COPP).
5. Functions of State Drug Regulatory Authorities (SDRAs).
6. Define clinical trials? Why are the clinical trials required?
10 MARKS Long Questions
1. Explain the CDSCO and COPP.
2. Write a note on Drug Technical Advisory Board (DTAB) and its functions.
3. Write a note on Drug Approval of New Drugs in India.
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