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Bpharm 7 Sem Industrial Pharmacy 2 bp702t 2022

This document is a question paper for an Industrial Pharmacy II exam consisting of 3 sections. Section A contains 10 short answer questions worth 2 marks each, covering topics like platform technology, SUPAC guidelines, regulatory agencies in India, regulatory affairs department functions, non-clinical drug development, Six Sigma concept, ISO 14000 standards, and CDSCO responsibilities. Section B contains 2 long answer questions worth 10 marks each on technology transfer protocols and FDA submission data presentation. Section C contains 5 short answer questions worth 7 marks each covering pilot plant scale-up personnel requirements, technology transfer steps, legal issues in development and transfer, regulatory affairs responsibilities, clinical research definitions and protocols, and the Quality by Design concept.

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Parul Sharma
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131 views1 page

Bpharm 7 Sem Industrial Pharmacy 2 bp702t 2022

This document is a question paper for an Industrial Pharmacy II exam consisting of 3 sections. Section A contains 10 short answer questions worth 2 marks each, covering topics like platform technology, SUPAC guidelines, regulatory agencies in India, regulatory affairs department functions, non-clinical drug development, Six Sigma concept, ISO 14000 standards, and CDSCO responsibilities. Section B contains 2 long answer questions worth 10 marks each on technology transfer protocols and FDA submission data presentation. Section C contains 5 short answer questions worth 7 marks each covering pilot plant scale-up personnel requirements, technology transfer steps, legal issues in development and transfer, regulatory affairs responsibilities, clinical research definitions and protocols, and the Quality by Design concept.

Uploaded by

Parul Sharma
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Subject Code: BP702T
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B PHARM
(SEM VII) THEORY EXAMINATION 2021-22
INDUSTRIAL PHARMACY II
Time: 3 Hours Total Marks: 75
Note: 1. Attempt all Sections. If require any missing data; then choose suitably.

SECTION A

1. Attempt all questions in brief. 10 x 2 = 20


a. Mention two major applications of platform technology.
b. Mention the basic role of SUPAC guidelines.
c. Name at least 4 agencies responsible for successful technology transfer in India.
d. State the role of one major TT agency of India.
e. State to important functions of the Regulatory Affairs Department.
f. What do you mean by ‘Non-Clinical Drug Development’?
g. What do you mean by ‘Six Sigma concept,’?

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90
h. Mention the specifications of ISO 14000 series of quality systems standards.

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i. State the responsibilities of CDSCO.

2.
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j. Mention the significance of COPP.
2O

5.
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P2

SECTION B
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Q

2. Attempt any two parts of the following: 2 x 10 = 20


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a. State and explain the Technology transfer protocol following WHO guidelines.
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b. Describe the steps of data presentation for FDA Submissions.


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c. Give a brief idea on regulatory requirements and approval procedures for new drugs.
:
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SECTION C
22

3. Attempt any five parts of the following: 7 x 5 = 35


20

a. Explain the significance of personnel requirements in pilot plant scale up.


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b. Describe the steps for technology transfer from RD to production.


Ja

c. State and explain the legal issues during technology development and transfer.
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d. Explain the responsibilities of the regulatory affairs professionals.


e. Define clinical research and state the clinical research protocols.
f. Write a brief note on the concept of Quality by Design (QbD).
g. Describe the functionalities of the Central Drug Standard Control.

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QP22O1P_290 | 04-Jan-2022 13:53:28 | 117.55.242.131
 

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