Industrial Pharmacy 2 Important Questions are most helpful for the B.Pharm 7th semester examination. You can also download the suggestions PDF.
Pilot Plant Scale Up Techniques
Very Short Answer Questions
1) Define pilot plant scale-up technique.
2) Define dry blending method.
3) What is wet granulation?
4) Enlist steps of liquid manufacturing process.
5) Write full form of SUPAC and ANDAs.
6) Give the test documentation for level 1 site changes.
7) Mention the test documentation for level 2 site changes.
8) Enumerate types of platform technologies.
Short Answer Questions
1) Give significance of pilot plant studies.
2) Write a note on space requirement for pilot plant scale-up.
3) Enlist items which should be a part of GMP for scale-up of a new product.
4) Enlist the different parameters and methods utilized for characterizing granules.
5) Discuss direct compression.
6) Write an illustrative note on granulation.
Long Answer Questions
1) What are the objectives and steps involved in the scale-up process?
2) Give any seven general considerations for pilot plant scale-up.
3) Briefly discuss pilot plant scale-up considerations for solids.
4) Mention the formulation aspects of liquid orals.
5) Write a detailed note on levels of site changes and batch size changes.
6) Write an illustrative note on *in-vitro* dissolution and *in-vivo* bioequivalence studies.
7) Enumerate different types of platform technology and explain them.
Technology Development and Transfer
Very Short Answer Questions
1) Define API and Bracketing.
2) Define technology transfer process.
3) What do you mean by FPP and DMF?
4) Define the terms IQ and OQ.
5) What is VMP?
6) Name some of the regulatory bodies for drug approval.
Short Answer Questions
1) Write a short note on the technology transfer process.
2) Write a note on technology transfer protocol.
3) Write about technology transfer documentation.
4) Give a note on APCTT and NRDC.
Long Answer Questions
1) Briefly explain Quality Risk Management (QRM).
2) Give a detailed note on transfer from R&D to production.
3) Write an illustrative note on the granularity of the technology transfer process.
Technology Transfer Related Documentation
Very Short Answer Questions
1) Define one-way and two-way agreements.
2) What do you mean by exhibit batches?
3) Define confidentiality agreement.
4) What is a technology transfer plan?
Short Answer Questions
1) Enumerate the documents related to technology transfer.
2) Explain memorandum of understanding and legal issues.
3) Discuss licensing of technology transfer-related documentation.
Long Answer Questions
1) Write a detailed note on the confidentiality agreement.
Regulatory Affairs
Very Short Answer Questions
1) Define regulatory affairs.
2) Mention the objectives of regulatory affairs.
Short Answer Questions
1) What are the scope and challenges of regulatory affairs authorities?
2) Explain the role of the regulatory affairs department.
Long Answer Questions
1) Briefly discuss the historical overview of regulatory affairs.
2) Discuss the responsibilities of regulatory affairs professionals.
Regulatory Requirements for Drug Approval – I
Very Short Answer Questions
1) Define drug approval processes.
2) Write the full form of CDSCO and DCGI.
3) What do you mean by pharmacokinetics?
4) What is genotoxicity?
5) Define carcinogenicity.
Short Answer Questions
1) Write a note on the drug approval process in India.
2) Write a note on data presentation for FDA submission.
3) What is non-clinical drug development? Also, mention its goals.
4) Write a note on toxicokinetics.
Long Answer Questions
1) Briefly discuss drug development teams.
2) Explain pharmacology in detail.
Regulatory Requirements for Drug Approval – II
Very Short Answer Questions
1) Define IND.
2) Enlist the types of IND.
3) What is an investigatorās brochure?
4) What is NDA?
5) Give the objectives of the clinical development of a drug candidate.
6) Define drug dependence and abuse potential.
7) How can you calculate Cmax and MRT?
8) What are the responsibilities of a trial manager in clinical studies?
Short Answer Questions
1) What information should be present on the cover sheet of an IND application?
2) What pharmacology and toxicology information should be present in an IND application?
3) Write about the archival and review copy of NDA.
4) Write a note on clinical research phase studies.
5) Discuss the types of bioequivalence studies.
6) Write a note on statistical evaluation of bioequivalence data.
Long Answer Questions
1) Enumerate in detail the content and format of an IND application.
2) Mention the information to be included in an IB.
3) Briefly discuss clinical research protocols.
4) Write a detailed note on the design of a single-dose bioequivalence study.
5) Illustrate biostatistics in pharmaceutical product development.
Quality Management System
Very Short Answer Questions
1) Define Quality Management System (QMS).
2) What are the benefits of ISO 9001:2015?
3) Give the advantages of QbD.
4) Differentiate between DMAIC and DMADV.
5) Give the benefits of a change control system.
6) Give the benefits of ISO 9000.
7) Write about ISO 14000 certification.
Short Answer Questions
1) Discuss the concept of quality.
2) Give the advantages and disadvantages of TQM.
3) Discuss the objectives of QbD.
4) Write the objectives and applications of the six sigma concept.
5) Give the procedure of a change control system.
6) Give the principles of ISO 9000.
Long Answer Questions
1) Write a detailed note on the principles of total quality management.
2) Write an illustrative note on the six sigma concept.
3) Briefly discuss phase I of out-of-specifications.
4) Write a detailed note on GLP and NABL.
Indian Regulatory Requirements
Very Short Answer Questions
1) Write the full form of CDSCO and name the person who heads the organization.
2) What is SLA?
3) Give the aims of CoPP.
Short Answer Questions
1) Mention the organization and responsibilities of SLA.
2) Mention the types and scope of CoPP.
Long Answer Questions
1) Discuss the structure and functions of the CDSCO.
2) Briefly discuss regulatory requirements and approval procedures for new drugs.