Rajiv Gandhi University of Health Sciences, Karnataka

VII Semester B. Pharm Degree Examination – 17-Mar-2021

Time: Three Hours Max. Marks: 75 Marks

INDUSTRIAL PHARMACY - II
Q.P. CODE: 5030
Your answers should be specific to the questions asked
Draw neat labeled diagrams wherever necessary
All the Questions are compulsory

LONG ESSAYS 2 x 10 = 20 Marks

1. What are the different platform technology and explain.
OR
Discuss the granularity of TT process for API and excipients
2. Discuss in detail investigator’s brochure.

SHORT ESSAYS 7 x 5 = 35 Marks

3. What are the objectives and significance of pilot-plant?
OR
Discuss about documentation and premises for TT as per WHO guidelines.
4. How bioequivalence are documented?
OR
Name the various regulatory authorities and write their responsibilities.
5. List out the goals of TT.
6. Explain the different phases of out of specification analysis (OOS).
7. Explain the significance of change control in quality management system.
8. Write a note on state licensing authority.
9. What are the responsibilities of CDSCO?

SHORT ANSWERS 10 x 2 = 20 Marks

10. Name any four general requirements for pilot-plant construction.
11. What are the different parts in batch manufacturing record?
12. What is drug master file?
13. Define technology transfer according to WHO.
14. What is Dossier?
15. What are the types of IND?
16. Define confidentially agreement.
17. What is six sigma?
18. What are the benefits of QbD?
19. Name the different modules of CTD.

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 Rajiv Gandhi University of Health Sciences, Karnataka
VII Semester B. Pharm Degree Examination – 12-Nov-2021

Time: Three Hours Max. Marks: 75 Marks

INDUSTRIAL PHARMACY - II
Q.P. CODE: 5030
Your answers should be specific to the questions asked
Draw neat labeled diagrams wherever necessary
All the Questions are compulsory

LONG ESSAYS 2 x 10 = 20 Marks

1. Explain in detail Pilot plant scale up considerations for Liquid orals. Write a note on platform technology.
OR
What is technology transfer? Discuss the TT protocol, process, packaging and cleaning.
2. Discuss regulatory requirement of NDA approval process, modules of CTD.

SHORT ESSAYS 7 x 5 = 35 Marks

3. Write about USFDA guideline for Good laboratory Practices.
OR
Write a note on different phases of Clinical trials.
4. Write the CDSCO guidelines for BA and BE studies.
OR
Write a note on Total quality management and Quality by design.
5. Discuss the SUPAC guidelines.
6. Explain briefly the handling of out of specification (OOS).
7. Write a note on Certificate of Pharmaceutical Product.
8. Define Documentation, APCTD, FDA, CTD and QbD.
9. Write the general considerations of Pilot plant.

SHORT ANSWERS 10 x 2 = 20 Marks

10. Elements of TQM.
11. Define clinical research protocol.
12. What is innovation and collaboration?
13. Quality control in Technology transfer.
14. What is CMC and preclinical testing?
15. Prospective validation.
16. Detection limit and Quantitation limit.
17. What is investigators brochure?
18. Write about similarity factors and its significance.
19. Write the principles of total quality management.

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 Rajiv Gandhi University of Health Sciences, Karnataka
VII Semester B. Pharm Degree Examination – 15-Jun-2022

Time: Three Hours Max. Marks: 75 Marks

INDUSTRIAL PHARMACY - II
Q.P. CODE: 5030
Your answers should be specific to the questions asked
Draw neat labeled diagrams wherever necessary
All the Questions are compulsory

LONG ESSAYS 2 x 10 = 20 Marks

1. Explain in detail about the significance of pilot-plant scale up study and large scale manufacturing techniques
of Liquid orals.
OR
Discuss technology transfer from R and D to production as per WHO guidelines.
2. Write a note on historical overview of RA.

SHORT ESSAYS 7 x 5 = 35 Marks

3. Explain the protocol for pilot-plant scale up for tablet production.
OR
Discuss the significance of quality risk management studies in technology transfer.
4. Name the various TT agencies in India. Explain TIFAC.
OR
Write the various applications of biostatistics in pharmaceutical product development.
5. What are the contents in the investigator’s brochure?
6. Define TQM. What are the key elements of TQM?
7. Write brief note on QbD concepts? Give its advantages.
8. Explain the different modules of CTD.
9. What are the general requirement for submission of application for issue of COPP?

SHORT ANSWERS 10 x 2 = 20 Marks

10. write two importance of platform technology.
11. What is the purpose of SUPAC guidelines?
12. What is standard operating procedure?
13. Define process validation.
14. What is New drug application?
15. Write the functions of regulatory authorities
16. What are the benefits ISO 9000?
17. Differentiate between assignable and non assignable causes as per OOS.
18. What is CDSCO and COPP?
19. Two functions of state licensing authority.

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 Rajiv Gandhi University of Health Sciences, Karnataka
VII Semester B. Pharm Degree Examination – 17-Nov-2022

Time: Three Hours Max. Marks: 75 Marks

INDUSTRIAL PHARMACY - II
Q.P. CODE: 5030
Your answers should be specific to the questions asked
Draw neat labeled diagrams wherever necessary
All the Questions are compulsory

LONG ESSAYS 2 x 10 = 20 Marks

1. Explain the various general requirements for setting up a pilot plant for pharmaceutical preparation.
OR
Discuss the stages involved in technology transfer in pharmaceutical industry.

2. Discuss general consideration of investigational New drug application.

SHORT ESSAYS 7 x 5 = 35 Marks

3. Discuss the importance of platform technology.
OR
How analytical methods are exchanged in a technology transfer.
4. Explain technology transfer sample protocol in pharmaceuticals.
OR
Write a note on drug development team and their functions.
5. Discuss the different phases of clinical trials.
6. Discuss the objectives and scope of GLP in pharmaceutical industry.
7. Describe the procedure for NABL accreditation.
8. Discuss the scope and objectives of COPP (Certificate of Pharmaceutical Product).
9. Write the functions of Drug Controller General of India (DCGI).

SHORT ANSWERS 10 x 2 = 20 Marks

10. What is the difference between pilot scale and scale up?
11. What is SUPAC?
12. What do you mean by Sending Unit and Receiving Unit
13. What is Operational Qualification (OQ) and Performance Qualification (PQ)
14. What is a regulatory affair? What are its Goals?
15. What are BA-BE studies? What is the need of BA–BE studies?
16. Two advantages of implementing TQM.
17. Enlist the benefits of ISO 14000.
18. Two functions of Drugs technical advisory board (DTAB).
19. What is common technical document (CTD)?
Rajiv Gandhi University of Health Sciences, Karnataka
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 Rajiv Gandhi University of Health Sciences, Karnataka
VII Semester B. Pharm Degree Examination – 31-May-2023

Time: Three Hours Max. Marks: 75 Marks

INDUSTRIAL PHARMACY - II
Q.P. CODE: 5030
Your answers should be specific to the questions asked
Draw neat labeled diagrams wherever necessary
All the Questions are compulsory

LONG ESSAYS 2 x 10 = 20 Marks

1. Explain how master formula records and batch manufacturing records are developed in pilot plant scale up studies.
OR
Discuss quality risk management studies as per ICHQ9 guideline.
2. Discuss the Role of regulatory affairs department in pharma industry.

SHORT ESSAYS 7 x 5 = 35 Marks

3. What is a pilot plant? What is the significance of Pilot Plant scale up techniques?
OR
What are the Barriers of Technology Transfer?
4. Discuss the TT Process of packaging materials.
OR
Explain the Different Phases of drug development.
5. Describe the key elements in managing clinical programs.
6. What are the advantages of Implementing TQM?
7. What is the Benefits of NABL accreditation?
8. Write a note on Central Drugs Testing Laboratories (CDTL).
9. Describe the Organization of CDSCO with flow diagram.

SHORT ANSWERS 10 x 2 = 20 Marks

10. Enlist the significances of batch formula record.
11. How equipment are categorized as per SUPAC guideline
12. Write the two importance of Technology Transfer in Pharmaceutical Industry.
13. Write the primary objectives NRDC.
14. Write two key elements in managing clinical programs.
15. Write the significance BE study.
16. What is zero-defect product?
17. What are the objectives of GLP?
18. Two functions of Port Offices of CDSCO
19. Write the types of drugs for which COPPs may be issued.

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 Rajiv Gandhi University of Health Sciences, Karnataka
VII Semester B. Pharm Degree Examination – 04-Nov-2023

Time: Three Hours Max. Marks: 75 Marks

INDUSTRIAL PHARMACY - II
Q.P. CODE: 5030
Your answers should be specific to the questions asked
Draw neat labeled diagrams wherever necessary
All the Questions are compulsory

LONG ESSAYS 2 x 10 = 20 Marks

1. Give Regulatory Requirements for INDA approval process.
OR
Explain the concepts of Total Quality Management and Quality by Design (QbD).
2. Explain the objectives and functions CDSCO and COPP.

SHORT ESSAYS 7 x 5 = 35 Marks

3. Write a note on scale up process approval changes.
OR
Give the details about Quality Risk Management.
4. Discuss the Technology Transfer agencies in India.
OR
Explain the significance of documentation in BA – BE studies.
5. Write in detail about Pilot plant scale up considerations for solids.
6. Write a note on documentation of finished products and packaging materials.
7. What is clinical research protocols and data presentation?
8. Write the elements of ISO14000.
9. Discuss the significance of GMP.

SHORT ANSWERS 10 x 2 = 20 Marks

10. Write the significance of personnel requirements in pharma industry.
11. Write the guidelines for technology transfer (TT).
12. Write the functions of clinical studies.
13. What is State licensing authority?
14. What are the objectives of NRDC?
15. What are MoUs and confidential agreement?
16. Define qualification and validation.
17. Discuss the Role of Regulatory affairs department.
18. What is six sigma concept and OOS?
19. Enlist salient features of ISO 9000.

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 Rajiv Gandhi University of Health Sciences, Karnataka
VII Semester B. Pharm Degree Examination – 30-May-2024

Time: Three Hours Max. Marks: 75 Marks

INDUSTRIAL PHARMACY - II
Q.P. CODE: 5030
Your answers should be specific to the questions asked
Draw neat labeled diagrams wherever necessary
All the Questions are compulsory

LONG ESSAYS 2 x 10 = 20 Marks

1. Explain the protocol for pilot plant scale up for tablets production.
OR
Discuss the Granularity of TT Process for Active Pharmaceutical Ingredients (API) and excipients.
2. Explicit the data’s to be submitted during New Drug Application (NDA) filing.

SHORT ESSAYS 7 x 5 = 35 Marks

3. Discus the Significance of personnel requirements in pilot plant scale up.
OR
Discuss the Documentation process involved in TT.
4. Differentiate between qualification and validation with suitable examples.
OR
Discuss the Types of studies involved in Pre-clinical Drug Development.
5. Describe the organization of CDSCO with proper flow diagram
6. Write a note on QbD concept as per ICH Q8 Guidelines.
7. Write a note ISO 14000 Guidelines.
8. Write a note on Drug Technical Advisory Board (DTAB) and its functions.
9. Discuss new drugs approval process in India.

SHORT ANSWERS 10 x 2 = 20 Marks

10. What are the different parts of batch manufacturing record?
11. What is platform technology?
12. Write any two reasons for technology transfer in Pharmaceutical Industry.
13. Write the functions of BCIL.
14. List out various Regulatory Authorities.
15. Enlist the key elements in managing clinical programs.
16. Write the four reasons for disqualification of testing facilities.
17. Classify Changes and give examples.
18. What is CTD?
19. Differentiate the assignable and non-assignable causes as per OOS.

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 Rajiv Gandhi University of Health Sciences, Karnataka
VII Semester B. Pharm Degree Examination – 24-Oct-2024

Time: Three Hours Max. Marks: 75 Marks

INDUSTRIAL PHARMACY - II
Q.P. CODE: 5030
Your answers should be specific to the questions asked
Draw neat labeled diagrams wherever necessary
All the Questions are compulsory

LONG ESSAYS 2 x 10 = 20 Marks

1. Explain the requirements for pilot plant scale up of Semisolids.
OR
Define technology transfer? Explain the different stages of technology
2. Explain the functioning of various Drug Development Teams.

SHORT ESSAYS 7 x 5 = 35 Marks

3. Define clinical trials. Why are the clinical trials required?
OR
Write a note on Platform Technology.
4. List out Risk management methodology.
OR
Discuss the Equipment requirements for TT?
5. Discuss the Scope and objectives of Regulatory Affairs.
6. Write a note on Investigator’s Brochure
7. Discuss the approval and implementation of Change control management System in Pharmaceutical Industry.
8. Write the Functions of Drugs Controller General of India (DCGI).
9. Describe the Process to apply for a COPP.

SHORT ANSWERS 10 x 2 = 20 Marks

10. Name the contents of batch manufacturing record.
11. Name any four general requirements for pilot plant construction
12. WHO guidelines for technology transfer.
13. Write salient features of CTD.
14. Write the significances of BA-BE Study.
15. What is ADR reporting
16. Define TQM? What are the key elements of TQM?
17. Enlist the benefits of ISO 14000.
18. List out places of Zonal offices and Sub-zonal offices of CDSCO.
19. What is the scope of COPP?

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