Code No: 247AB R17

JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD

B. Pharmacy IV Year I Semester Examinations, January/February - 2023
INDUSTRIAL PHARMACY - II
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Time: 3 Hours Max. Marks: 75

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.
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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
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(25 Marks)

1.a) What are the advantages of pilot studies? [2]

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b) What is platform technology? Mention its importance. [3]
c) What are the goals of technology transfer? [2]
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d) Define MoUs. Mention the details to be included in a MoU. [3]
e) What are BA and BE studies? [2]
f) What is regulatory affairs? Mention its goal? [3]
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g) What are the three aspects of TQM? [2]
h) Define Quality by design. Enlist its importance in pharmacy. [3]
i) Enlist the functions of State licensing Authority. [2]
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j) Mention different modules for permission of New Drugs Approval. [3]

PART – B
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(50 Marks)
2.a) Discuss the significance of space requirements in pilot plant scale up.
b) Write in brief SUPAC guidelines. [5+5]
OR
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3. Explain the pilot plant scale-up techniques for solid dosage forms. [10]

4.a) What are Technology Of Transfer (TOT) related documents? Write about confidentiality
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agreements and licensing.
b) How process, packaging and cleaning aspects are taken care in R&D to production
cycle? [5+5]
OR
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5. Write guidelines for technology transfer and technology transfer protocol as per WHO.
[10]
6.a) Discuss the roles of regulatory affairs department.
b) Mention the requirements of clinical trials. Write about different phases of clinical
trials? [5+5]
OR
7.a) Write about general considerations of IND application.
b) Discuss how clinical studies are managed? [5+5]
8. Explain the Six Sigma concept in detail. [10]
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9.a) Mention and write different stages in NABL.
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b) Write a short note on Out Of Specification (OOS). [6+4]

10. Explain about the organization and responsibilities of CDSCO. [10]

OR
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11.a) Write a short note on Common Technical Document (CTD).
b) Discuss about Certificate of Pharmaceutical Product (COPP). [5+5]
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Code No: 247AA R17
JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD
B. Pharmacy IV Year I Semester Examinations, January/February - 2023
INSTRUMENTAL METHODS OF ANALYSIS
Time: 3 Hours Max. Marks: 75

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.
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PART – A
(25 Marks)
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1.a) Create the Jablonski Energy Diagram. [2]

b) Generate the equation of Beer-Lambert’s Law. [3]
c) Justify the reason on which types of sample undergoes Atomic Absorption
Spectroscopy. [2]
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d) Assess the principle involved in Nepheloturbidometry. [3]

e) How do you interpret the Rf value in Chromatography. [2]
f) How do you develop a TLC plate using Silica gel at lab conditions? [3]
Support the statement “HPLC (High Performance Chromatography) is also known as
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g)
High Pressure Chromatography. [2]
h) Assess and tell why and how temperature programming is done in GC. [3]
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i) Justify on the principle involved in Gel Chromatography. [2]

j) Generate the physical properties of Ion exchange resins. [3]
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PART – B
(50 Marks)
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2.a) Define the terms ‘Chromophore’ and ‘Auxochrome’. Compare and describe about
various shifts involved in UV-Visible spectroscopy by constructing a neat graph.
b) List and explain on various types of Quenching involved in Fluorescence. [5+5]
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OR
3.a) Demonstrate and explain the instrumentation involved in Fluorimetry.
b) List the applications of UV-Visible spectroscopy. Summarize on Single and multi-
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Component analysis. [5+5]

4.a) Demonstrate on the procedure involved in sample preparation of solids and liquids for
IR Spectroscopic analysis.
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b) Describe the construction and working of Duboscq Colorimeter involved in Nephelo-

meter. [5+5]
OR
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5.a) Explain in detail the various factors involved in IR spectroscopy.

b) Construct the block diagram of Internal Standard Flame Photometer and explain its
working. [5+5]

6.a) Compare the Advantages and Disadvantages of TLC with that of Paper
Chromatography.
b) Summarize on the procedure involved in Gel Electrophoresis. [5+5]
OR
7.a) Categorize and describe on various types of development techniques involved in Paper
Chromatography.
b) List the types and summarize the Applications on Electrophoresis. [5+5]
8.a) Explain in detail various derivatization techniques involved in Gas Chromatography.
b) Enumerate the applications of HPLC. [6+4]
OR
9.a) List out the various detectors involved in HPLC. Describe the Construction and
Working of UV detector.
b) Construct only the block diagram of Gas Chromatography Instrument. List the ideal
properties of Mobile Phase involved in Gas Chromatography. [5+5]
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10.a) Contrast the difference between Gel Filtration and Gel Permeation Chromatography.
List the stationary phases involved in Gel Chromatography.
b) Describe the working principle of Affinity Chromatography. [5+5]
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OR
11.a) Describe on Factors affecting Ion-exchange separations.
b) List the applications of Affinity Chromatography. [7+3]
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Code No: 247AD R17
JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD
B. Pharmacy IV Year I Semester Examinations, January/February - 2023
NOVEL DRUG DELIVERY SYSTEMS
Time: 3 Hours Max. Marks: 75
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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
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and may have a, b as sub questions.

PART – A (25 Marks)

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1.a) What are controlled drug delivery systems? Give examples. [2]
b) Define and classify polymers. [3]
c) What is microencapsulation? Write its advantages. [2]
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d) Define mucoadhesion. List mucoadhesive polymers. [3]
e) Define transdermal drug delivery systems. Name 2 marketed transdermal systems.[2]
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f) What are Gastroretentive delivery systems? Classify them. [3]
g) Describe the concept of Nanotechnology. [2]
h) Why targeted drug delivery systems required? [3]
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i) Write the advantages of ocular drug delivery systems. [2]
j) List the applications of Intra uterine devices. [3]
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PART – B (50 Marks)
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2.a) Classify controlled release dosage forms with examples.
b) Write about important considerations for selection of drug candidate. [5+5]
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3.a) Explain the diffusion-controlled systems with illustration.
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b) Differentiate between controlled release and sustained release dosage forms. [5+5]

4.a) Explain any two methods used for microencapsulation.

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b) Enlist the disadvantage of microcapsules. [5+5]
OR
5.a) Discuss the mechanism of mucoadhesion.
b) Explain the formulation of buccal patches with its applications. [5+5]
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6.a) Describe the formulation of dry powder inhalers. Give example of marketed inhaler.
b) Enlist the advantages of pulmonary route of drug delivery. [5+5]
OR
7.a) Discuss the concept of inflatable gastroretentive systems and its significance.
b) Why are gastroretentive systems formulated? [5+5]

8.a) Discuss the concept of targeted drug delivery.

b) Write about the formulation of Niosomes. [5+5]
OR
9.a) What are liposomes? Classify liposomes.
b) Explain any two methods of preparing liposomes. [5+5]
10.a) Discuss the concept of ocular drug delivery system.
b) Describe the formulation of ocular inserts. [5+5]
OR
11.a) Write about intra ocular barriers and the methods to overcome the same.
b) List the novel ocular dosage forms. [5+5]
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Code No: 247AC R17
JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD
B. Pharmacy IV Year I Semester Examinations, January/February - 2023
PHARMACY PRACTICE
Time: 3 Hours Max. Marks: 75
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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
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may have a, b as sub questions.

PART – A (25 Marks)

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1.a) What is patient record? [2]
b) What is secondary health centre? [3]
c) Define therapeutic drug monitoring. [2]
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d) How are ‘charge” floor drugs selected? [3]
e) Define tertiary drug information services. [2]
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f) What are open ended questions during patient counselling? [3]
g) Define omission error. [2]
h) What are components of prescribe medication order? [3]
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i) What is personal service drug store? [2]
j) How to control perishable inventory? [3]
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PART-B (50 Marks)

2.a) Classify hospital on clinical basis and discuss.

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b) Explain supportive paramedical services of a hospital. [5+5]
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3.a) Discuss responsibilities of a hospital pharmacist.
b) Elaborate upon dispensing of proprietary products. [5+5]
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4.a) Elaborate upon indications where therapeutic drug monitoring is not much important.
b) Discuss dispensing of drugs to out-patients. [5+5]
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OR
5.a) Explain prescribing of floor stock drugs.
b) Discuss objectives of community pharmacy management. [5+5]
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6.a) Compare and contrast primary and secondary drug information services.
b) Elaborate objectives of poison information centre. [5+5]
OR
7.a) Discuss different barriers in patient counselling.
b) Explain internal training programme at a hospital. [5+5]

8.a) Discuss various components of patient history and history taking.

b) Explain types of ward rounds. [5+5]
OR
9.a) Justify: Communication skills of a pharmacists is extremely important.
b) Explain labelling, distribution and supply of OTC drugs in India. [5+5]
10.a) Explain purchase report form.
b) Elaborate upon arrangements of a store room of a drugs store. [5+5]
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11.a) Discuss perpetual inventory.
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b) Explain methods used for the analysis of the drug expenditure. [5+5]

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Code No: 247AH R17
JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD
B. Pharmacy IV Year I Semester Examinations, January/February - 2023
QUALITY CONTROL AND STANDARDIZATION OF HERBALS
JN
Time: 3 Hours Max. Marks: 75

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.
TU
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 (25 Marks)

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1. a) What are the basic tests for quality control of herbal drugs? [2]
b) What is ash value? Write the importance of ash value. [3]
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c) Enumerate GLP requirements for traditional system of medicine. [2]
d) Write in short WHO guidelines on cGMP. [3]
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e) Write EU guidelines for quality control of herbal drugs. [2]
f) Give research guidelines for safety of herbal drugs [3]
g) Write the application of GC in standardization of herbal drugs [2]
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h) Explain complaints and recall as per GMP. [3]
i) What are WHO guidelines for safety monitoring of herbal medicine. [2]
j) Mention important regulatory requirements for herbal medicines. [3]
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PART – B (50 Marks)
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2.a) Explain advanced analytical methods for evaluation of crude drugs.
b) Give basic tests for identification of alkaloids and glycosides. [5+5]
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3.a) Discuss WHO guidelines for quality control of herbal drugs.
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b) Describe the method to determine heavy metals in herbal preparations. [5+5]

4.a) What is cGMP? And discuss WHO guidelines on cGMP of herbal drugs.
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b) Write a note on quality assurance in herbal industry. Explain the importance of cGMP.
[5+5]
OR
5.a) Explain infrastructural requirements for herbal industry as per GMP guidelines.
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b) List out WHO guidelines for assessment of herbal drugs.
c) Explain factors effecting cultivation and collection of medicinal plants as per GACP.
[3+3+4]
6.a) Write a note on ethical consideration on the research of herbal medicine.
b) Explain ICH guidelines for assessment of quality of herbal drugs. [5+5]
OR
7.a) Discuss research guidelines for evaluation of safety and efficacy of herbal drugs.
b) Explain the importance of European medicine agency on quality of herbal drugs. [5+5]
8.a) Explain the application of HPLC & TLC for standardization of herbal drugs.
b) Explain the importance of HPTLC in standardization of herbal drugs. [5+5]
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OR
9.a) Write a note on document preparation for new drug application.
b) Explain GMP requirements for herbal drugs as per Drugs and Cosmetics Act. [5+5]
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10.a) Write the WHO guidelines for safety monitoring of herbal drugs in pharmacovigilance
systems
b) Explain role of chemical markers in standardization of herbal drugs. [5+5]
OR
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11.a) Discuss the safety of herbal drugs as per various pharmacopoeias.
b) Mention regulatory requirements for herbal drugs. [5+5]
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