JNTU
JNTU B.Pharmacy IV INDUSTRIAL PHARMACY-II Previous Question Paper (January/February - 2023 - R17)
Note: i) Question paper consists of Part A, Part B. ii) Part A is compulsory, which carries 25 marks. In Part A, Answer all questions. iii) In Part B, Answer any one question from each unit. Each question carries 10 marks and may have a, b as sub questions.
Part A
What are the advantages of pilot studies?
Answer
Pilot studies allow for the identification of potential problems in the manufacturing process before full-scale production, ensure the reproducibility of the product, and provide critical data for process validation and optimization.
What is platform technology? Mention its importance.
Answer
Platform technology refers to a foundational set of technologies or processes that can be adapted to develop multiple products. Its importance lies in reducing development time and costs, improving consistency across product lines, and facilitating regulatory approval by leveraging established safety and efficacy data.
What are the goals of technology transfer?
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Define MoUs. Mention the details to be included in a MoU.
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What are BA and BE studies?
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What is regulatory affairs? Mention its goal?
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What are the three aspects of TQM?
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Define Quality by design. Enlist its importance in pharmacy.
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Enlist the functions of State licensing Authority.
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Mention different modules for permission of New Drugs Approval.
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Part B
Discuss the significance of space requirements in pilot plant scale up.
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Write in brief SUPAC guidelines.
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Explain the pilot plant scale-up techniques for solid dosage forms.
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What are Technology Of Transfer (TOT) related documents? Write about confidentiality agreements and licensing.
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How process, packaging and cleaning aspects are taken care in R&D to production cycle?
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Write guidelines for technology transfer and technology transfer protocol as per WHO.
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Discuss the roles of regulatory affairs department.
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Mention the requirements of clinical trials. Write about different phases of clinical trials?
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Write about general considerations of IND application.
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Discuss how clinical studies are managed?
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Explain the Six Sigma concept in detail.
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Mention and write different stages in NABL.
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Write a short note on Out Of Specification (OOS).
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Explain about the organization and responsibilities of CDSCO.
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Write a short note on Common Technical Document (CTD).
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Discuss about Certificate of Pharmaceutical Product (COPP).
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