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pharmacyQuestion paper

GTU 2020 Question Paper B.Pharm Sem:- 7 All Subject

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GUJARAT TECHNOLOGICAL UNIVERSITY
B.Ph. SEMESTER–VII • EXAMINATION – WINTER-2020

Subject Code: BP701TP Date:01/01/2021
Subject Name: Instrumental Method of Analysis
Time: 10:30AM To 12:30PM Total Marks: 54
Instructions:

  1. Attempt any THREE questions from Q-1 to Q-6.
  2. Q.7 is compulsory to attempt.
  3. Make suitable assumptions wherever necessary.
  4. Figures to the right indicate full marks.
    Q.1 (a) Derive Beer’s Law. Give reasons for deviations from Beer’s law? 06
    (b) Define Chromphores, auxochromes and Bathochromic shift with example. 05
    (c) What is chemical quenching? Give its example. 05
    Q.2 (a) Explain sample handling in IR spectroscopy. 06
    (b) Describe Principle and instrumentation of Flame photometry. 05
    (c) Describe thermal detectors used in IR spectrophotometry. 05
    Q.3 (a) Describe principle involved in separation in TLC along with stationary 06

Phases used in TLC.
(b) Give advantages and disadvantages of Adsorption chromatography 05
(c) What are the modes of development in paper chromatography? 05
Q.4 (a) Write a note on Gel electrophoresis along with its applications. 06
(b) Give applications of Thin Layer Chromatography. 05
(c) Describe principle and applications of Atomic absorption spectroscopy 05
Q.5 (a) What is the principle and which carrier gas is suitable for use in 06
a. Katharometer b. Flame ionization detector c. Electron capture detector
(b) Differentiate between isocratic and gradient elution technique. 05
(c) Define Retention time, Retention Volume, Resolution and HETP. 05
Q. 6 (a) What is an Ion exchange resin? 06
(b) Write factors affecting ion exchange chromatography 05
(c) Give application of Gel and affinity chromatography. 05
Q.7 (a) Which principle is involved in Normal Phase and Reverse Phase chromatography 06

OR

(a) What are the different types of vibrations? Explain in detail 06

OR

(a) Explain Instrumentation of UV-Visible spectrophotometer 06


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Seat No.: _ Enrolment No. _____
GUJARAT TECHNOLOGICAL UNIVERSITY
B.Ph -SEMESTER–VII • EXAMINATION – WINTER -2020

Subject Code: BP702TT Date: 04/01/2021
Subject Name: INDUSTRIAL PHARMACY II
Time: 10:30AM To 12:30PM Total Marks: 54
Instructions:

  1. Attempt any THREE questions from Q-1 to Q-6.
  2. Q.7 is compulsory to attempt.
  3. Make suitable assumptions wherever necessary.
  4. Figures to the right indicate full marks.
    Q.1 (a) Describe the procedure for new drug approval from CDSCO in India. 06
    (b) Describe the investigator’s brochure for IND. 05
    (c) Write short note on Six sigma as a tool for quality management. 05
    Q.2 (a) Write the benefits of ISO to an organization. Write a note on ISO 9001:2008. 06
    (b) Describe the basic concepts of TQM. 05
    (c) Discuss change control in quality management system. 05
    Q.3 (a) Explain in brief SUPAC guidelines for immediate release solid oral dosage

forms.

06
(b) Write a note on platform technology citing appropriate example. 05
(c) Write briefly on NABL certification. 05
Q.4 (a) Write a detail note on pilot plant scale up of tablets. 06
(b) Discuss selection of pharmaceutical packaging materials. 05
(c) Explain the documentation in technology transfer. 05
Q.5 (a) Write a note on “Approved regulatory bodies and agencies of India for TT”. 06
(b) Write about role of regulatory affairs department. 05
(c) Write a note on COPP. 05
Q. 6 (a) What is Technology transfer? Write importance of Technology transfer in

pharmaceutical industry.

06
(b) Discuss in detail various factors affecting design of a pharmaceutical pilot plant
facility.

05
(c) Write a note on clinical research protocol. 05
Q.7 (a) Write a brief note on qualification and validation in technology transfer.

OR

06
(a) Write a note on state licensing authority under Indian regulatory requirements.

OR

06
(a) Write the protocol to conduct non clinical testing. 06


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Seat No.: _ Enrolment No. _____
GUJARAT TECHNOLOGICAL UNIVERSITY
B.Ph -SEMESTER–VII • EXAMINATION – WINTER -2020

Subject Code: BP703TT Date: 06/01/2021
Subject Name: PHARMACY PRACTICE
Time: 10:30AM To 12:30PM Total Marks: 54
Instructions:

  1. Attempt any THREE questions from Q-1 to Q-6.
  2. Q.7 is compulsory to attempt.
  3. Make suitable assumptions wherever necessary.
  4. Figures to the right indicate full marks.

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Seat No.: _ Enrolment No. _____
GUJARAT TECHNOLOGICAL UNIVERSITY
B.Ph. – SEMESTER– VII EXAMINATION – WINTER -2020

Subject Code: BP704TT Date: 08/01/2021
Subject Name: Novel Drug Delivery Systems
Time: 10:30AM To 12:30PM Total Marks: 54
Instructions:

  1. Attempt any THREE questions from Q-1 to Q-6.
  2. Q.7 is compulsory to attempt.
  3. Make suitable assumptions wherever necessary.
  4. Figures to the right indicate full marks.
    Q.1 (a) Write a note on Dissolution and Diffusion controlled release system. 06
    (b) Explain Biological factors affecting the design of oral sustained release drug
    delivery system.

05
(c) Briefly describe the importance of various properties of polymers. 05
Q.2 (a) What properties are required for the drug to be a candidate for Transdermal
drug deliverysystem? Explain formulation of Transdermal drug delivery
system.

06

(b) Describe Microencapsulation technique for particle coating. 05
(c) Define Muco adhesion. Describe the mechanisms of Bio adhesion. 05
Q.3 (a) Discuss limitations of Buccal delivery system. Give a detail about

Mucoadhesive polymers for Buccal delivery.

06
(b) Give on account of approaches for designing of Gasro retentive dosage form. 05
(c) Discuss in detail the evaluation parameters for Transdermal patches. 05
Q.4 (a) Discuss method of preparation of Nano particles. 06
(b) Classify Liposomes? Why Liposomes are considered versatile carriers for
parenteral drug delivery.

05

(c) Define Neosomes. Differentiate between liposomes and neosomes. Enlist
various applications of Neosomes in pharmaceuticals.

05
Q.5 (a) Describe the formulation of Nasal sprays. How is it evaluated? 06
(b) Explain in detail the method of producing Monoclonal antibodies by
Hybridoma technology.

05
(c) Discuss merits, demerits and application of Intra uterine devices (IUDs) 05
Q. 6 (a) Discuss challenges of Ocular drug delivery system. Suggest their remedies. 06
(b) Discuss any one innovation in Implantable drug delivery system in details. 05
(c) Write a note on Active targeting. 05
Q.7 (a) Discuss recent innovations in MDI (Metered dose inhaler) technology.

OR

06

(a) Discuss the formulation development of Osmotic tablets with example.

OR

06
(a) Write a note on evaluation parameters of Liposomes. 06


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Seat No.: _ Enrolment No. _____
GUJARAT TECHNOLOGICAL UNIVERSITY
B. Pharm – SEMESTER VII• EXAMINATION – WINTER -2020
Subject Code: BP706TT Date: 12/01/2021
Subject Name: Quality Assurance
Time: 10:30AM To 12:30PM Total Marks: 54
Instructions:

  1. Attempt any THREE questions from Q-1 to Q-6.
  2. Q.7 is compulsory to attempt.
  3. Make suitable assumptions wherever necessary.
  4. Figures to the right indicate full marks.
    Q.1 (a) Write is the difference between QA and QC. How QA, QC and GMP are

correlated?

06
(b) Enlist different ICH guidelines. Discuss in brief about Quality guideline. 05
(c) What is QbD? Discuss different tools of QbD. 05
Q.2 (a) Draw a sample plant layout for pharmaceutical industry along with space

required as per schedule M.

06
(b) Discuss maintenance of sterile area and control of contamination as a part of
plant premises.

05
(c) Discuss various quality control tests for secondary packaging materials. 05
Q.3 (a) Give brief note on ISO 9000 & ISO 14000? Discuss various steps for its

registration.

06
(b) Discuss principles of GLP. 05
(c) What is TQM? Explained various elements of TQM. 05
Q.4 (a) Give brief note on Quality control test for containers and rubber closures. 06
(b) What is difference between calibration, validation and qualification? Discuss any
two validation parameters in detail.

05
(c) Discuss various characteristics to be validated for different types of analytical
procedures.

05
Q.5 (a) What is a complaint? Discuss how to handle returns goods. 06
(b) Discuss BMR and its auditing with references to cGMP. 05
(c) Write a note on Master Formula Record. 05
Q. 6 (a) Define calibration. Discuss principles of calibration. 06
(b) Discuss general protocol for conduct of a Nonclinical laboratory study. 05
(c) Write brief note on SOP. 05
Q.7 (a) Discuss about personnel responsibility and hygiene in pharmaceutical industry.

OR

06

(a) What is NABL accreditation? Discuss its importance.

OR

06
(a) Write short note on Qualification of UV-Visible spectrophotometer.

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