JNTU
JNTU B.Pharmacy IV Year INDUSTRIAL PHARMACY-II Previous Question Paper (July - 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
Write the difference between pilot plant and scale up.
Answer
Pilot plant is the small-scale production facility used to evaluate the manufacturing process and product stability before full-scale production. Scale-up is the systematic process of increasing the batch size from the pilot scale to the commercial production scale while ensuring the product maintains its quality, safety, and efficacy.
Write any six objectives of pilot plant in a pharmaceutical industry.
Answer
- To evaluate the physical and chemical properties of the drug product.
- To develop and validate the manufacturing process.
- To identify critical process parameters and control limits.
- To provide samples for clinical trials and stability testing.
- To assess the suitability of equipment for large-scale production.
- To provide training to production personnel.
Define Technology Transfer as per WHO.
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How is quality control different from quality assurance?
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What do you mean by drug and regulation and write two importance of drug regulation?
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Write a note on the role of Regulatory affairs department.
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Define quality and quality management system.
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Write any four purpose of quality management system and define ISO.
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Write the importance of state licensing authority.
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Write a significance of clinical study report.
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PART - B
In detail discuss the steps in a scale up consideration for a solid pharmaceutical industry.
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Discuss the significance of raw materials and its selection procedure.
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Discuss in detail the scaleup concepts and techniques for semi solid products.
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Elaborate SUPAC along with its advantages and disadvantages.
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Discuss about the protocol of technology transfer.
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Explain with a diagram the Granularity of TT Process.
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Write a note on analytical method transfer.
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Write a note on the various TOT agencies in India.
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Discuss about the General considerations of Investigational New Drug (IND) Application.
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Write a note on the Responsibility of Regulatory Affairs Professionals.
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List out the various Drug regulatory systems in India. Discuss in detail about the CDSCO and its functions.
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Write the importance and the protocol for New Drug Application (NDA).
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Define Quality by design and discuss the various element of quality by design approach.
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Write a note on the steps to implement quality by management.
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Discuss in detail about the ISO 9000 and its various elements.
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Write a note on Out of Specifications (OOS).
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Write a detail note on the State Licensing Authority w.r.t its organization and responsibilities.
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Write the importance of CDSCO.
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Discuss the organization and preparation of Common Technical Document.
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Describe the general criteria for filing a Certificate of Pharmaceutical Product (COPP) application.
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