SLR-FG-1

Seat
No.
Set P
M. Pharmacy (Semester - I) (New) (CBCS) Examination March/April-2019
Pharmaceutics
MODERN PHARMACEUTICAL ANALYTICAL TECHNIQUES
Day & Date: Thursday, 02-05-2019 Max. Marks: 75
Time: 10:30 AM to 01:30 PM
Instructions: 1) All questions are compulsory.
2) Figures to the right indicate full marks.
Q.1 Answer any five questions. 25
a) Calculate 𝜆𝑚𝑎𝑥 the of the following structures
a) b)

b) What is electrophoresis and name different type of electrophoresis? Write a

note on capillary electrophoresis.
c) Describe Radio immune assay and write the applications.
d) Explain the principle of working X ray crystallography.
e) What are different electronic transitions and explain in detail.
f) Write a note on atomic absorption spectroscopy.
Q.2 Answer any three questions. 30
a) What is the principle involved in fluorescence. With neat labeled diagram
explain different parts of modern fluorimeter. Highlight few application of
spectrofluorimeter.
b) Describe rules employed for understanding the fragmentation in MS. Explain in
detail McLafforty rearrangement.
c) Enlighten in detail the factors influence chemical shift and add a note on
coupling constant.
d) What do you mean by ELISA and explain in detail different types of ELISA.
Q.3 20
a) What do you mean by gas chromatography? Write the types of mobile phased
in GC.
b) Draw neat labeled diagram of typical GC and explain in detail columns used in
GC.
c) Elaborate different detectors used in GC in detail.
d) Write the applications of GC.

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 SLR-FG-2
Seat
No.
Set P
M. Pharmacy (Semester – I) (New) (CBCS) Examination April/May-2019
Pharmaceutics
DRUG DELIVERY SYSTEM
Day & Date: Saturday, 04-05-2019 Max. Marks: 75
Time: 10:30 AM To 01:30 PM
Instructions: 1) All questions are compulsory.
2) Figure to the right indicates full marks.
Q.1 Solve any five questions. 25
a) Give an account on mucosal delivery of vaccines.
b) Write a note on osmotic activated drug delivery system.
c) What are barriers of drug permeation? Give methods to overcome barriers.
d) What is mean by penetration enhancer? Explain with proper example.
e) Explain 5 evaluation tests for ocular drug delivery system.
f) Classify with example polymers used in CR and SR dosage form.
Q.2 Solve any three questions. 30
a) Write formulation and evaluation of floating tablets.
b) Discuss designing, principles of rate controlled drug delivery system.
c) Define intracellular DDS, intercellular DDS, and transappendageal DDS.
Write in detail on evaluation of TDDS.
d) Discuss formulation evaluation of protein delivery system.
Q.3 Solve the following question. 20
a) Give detailed account on formulation and evaluation of CR and SR tablets.
Add a note on merits and demerits of CR and SR formulation.

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 SLR-FG-3
Seat
No.
Set P
M. Pharmacy (Semester – I) (New) (CBCS) Examination April/May-2019
Pharmaceutics
MODERN PHARMACEUTICS
Day & Date: Tuesday, 07-05-2019 Max. Marks: 75
Time: 10:30 AM To 01:30 PM
Instructions: 1) All questions are compulsory.
2) Figure to the right indicates full marks.
Q.1 Answer any FIVE of the following: 25
a) Explain in detail drug excipients interaction.
b) Discuss ICH guidelines for validation of Master plan.
c) Write note on: budget and cost control.
d) Give the objectives and policies of cGMPs.
e) Explain the storage conditions and testing frequency for the drug product.
f) Discuss theories of pharmaceutical Dispersion
Q.2 Answer any THREE of the following: 30
a) Define preformulation. Explain in details preformulation parameters.
b) Explain the concepts of total quality Management and discuss validation of
pharmaceutical process.
c) Discuss in detail IQ and DQ for Rapid Mixer Granulator
d) Explain in detail Higuchi Model and Korsmeyer-peppas model for drug
release.
Q.3 Answer the following: 20
What is Preformulation? Give its significance and discuss physics of tablet
compression.

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 SLR-FG-4
Seat
No.
Set P
M. Pharmacy (Semester – I) (New) (CBCS) Examination April/May-2019
Pharmaceutics
REGULATORY AFFAIR
Day & Date: Thursday, 09-05-2019 Max. Marks: 75
Time: 10:30 AM To 01:30 PM
Instructions: 1) All questions are compulsory.
2) Figure to the right indicates full marks.
Q.1 Answer any Five of the following. 25
a) Discuss the importance of monitoring of clinical trials.
b) Write a note on Abbreviated New Drug Application.
c) What is drug master file (DMF)? Discuss different types of DMF.
d) Explain the significance of biosimilars in pharmaceuticals.
e) Write a note on ICH guidelines on quality.
f) Describe the role of regulatory professional in pharmaceutical industry.
Q.2 Answer any three questions 30
a) Explain the role of drug regulating authorities in different countries in the
development of new drug.
b) What is 21 CFR Part 11? Describe its salient features.
c) Describe data submitted for chemistry requirements of NDA.
d) Explain in detail Phase-Ill and Phase-IV study Indian regulatory authority.
Q.3 Explain in detail the procedure of NDA filing to USFDA. 20

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 SLR-FG-10
Seat
No.
Set P
M. Pharmacy (Semester - I) (New) (CBCS) Examination April/May-2019
PHARMACEUTICAL QUALITY ASSURANCE
MODERN PHARMACEUTICAL ANALYTICAL TECHNIQUES
Day & Date: Thursday, 02-05-2019 Max. Marks: 75
Time: 10:30 AM to 01:30 PM
Instructions: 1) All questions are compulsory.
2) Figures to the right indicate full marks.
Q.1 Answer any five questions. 25
a) Draw the schematic fragmentation of following compounds fragmented in EI
MS.
1) Ethyl Benzene 2) Acetone
b) Write the principle involved in thermo gravimetric analysis.
c) Elaborate in detail any two electrodes employed in potentiometry.
d) Explain the factors which influences absorption of infra radiations by
compounds.
e) Write a note on paper electrophoresis.
f) Derive Beer Lambert equation.
Q.2 Answer any three questions. 30
a) Which are the factors which govern protons to resonate at different radio
frequencies elaborate in detail.
b) Explain in detail Bragg's law and instrumentation of typical X ray
crystallography.
c) With neat labeled diagram explain instrumentation of HPLC.
d) What is the principle in DSC. With diagram elaborate instrumentation of
DSC.
Q.3 a) List out the different types of ionization techniques in Mass Spectrometer 10
and explain in detail electron impact ionization and Electro spray ionization.
b) describe in detail time of flight and quadrapole mass analyzer. 10

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 SLR-FG-11
Seat
No.
Set P
M. Pharmacy (Semester – I) (New) (CBCS) Examination April/May-2019
Pharmaceutical Quality Assurance
QUALITY MANAGEMENT SYSTEM
Day & Date: Saturday, 04-05-2019 Max. Marks: 75
Time: 10:30 AM To 01:30 PM
Instructions: 1) All questions are compulsory.
2) Figure to the right indicates full marks.
Q.1 Answer any five questions: 25
a) Write a note on role of OHSAS guidelines in quality management.
b) Elaborate SPC and its advantages in quality management.
c) How can costs of quality be optimized? Elaborate.
d) Discuss in brief about annual product review.
e) Discuss in short about the process of Benchmarking.
f) What is Quality risk management? Discuss its importance.
Q.2 Answer any three questions: 30
a) What is TQM? Elaborate.
b) Explain how ICH Q8 helps us to manage risks.
c) Discuss the importance of 'Principles of Six Sigma' in pharma
manufacturing.
d) Discuss in brief about 'vendor qualification' and CAPA.
Q.3 Answer the following question: 20
a) What is customer focus? Discuss how it would help one in complying with
expectations of regulatory bodies and customers.

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 SLR-FG-12
Seat
No.
Set P
M. Pharmacy (Semester – I) (New) (CBCS) Examination April/May-2019
Pharmaceutical Quality Assurance
QUALITY CONTROL AND QUALITY ASSURANCE
Day & Date: Tuesday, 07-05-2019 Max. Marks: 75
Time: 10:30 AM To 01:30 PM
Instructions: 1) All questions are compulsory.
2) Figure to the right indicates full marks.
Q.1 Answer any FIVE of the following: 25
a) What are change control, change-in of components and calculation of yiels?
b) Give QC tests for containers and closures.
c) Brief the analysis of raw materials.
d) What are the SOPs of SOP?
e) What are CDER and CBER?
f) Give overview of ICH guidelines
Q.2 Answer any THREE of the following: 30
a) Give the manufacturing aspects of sterile products.
b) Give details of the batch formula record.
c) Describe the IPQC and FPQC tests for tablets and ophthalmic
d) Define control article & test article. How is non clinical laboratory study result
prepared & stored?
Q.3 Answer the following: 20
What is Pharmaceutical Inspection Convention? Explain the GMP guidelines for
drug industry location, construction, and plant lay out.

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 SLR-FG-13
Seat
No.
Set P
M. Pharmacy (Semester – I) (New) (CBCS) Examination April/May-2019
Pharmaceutical Quality Assurance
PRODUCT DEVELOPMENT AND TECHNOLOGY TRANSFER
Day & Date: Thursday, 09-05-2019 Max. Marks: 75
Time: 10:30 AM To 01:30 PM
Instructions: 1) All questions are compulsory.
2) Figure to the right indicates full marks.
Q.1 Answer any Five of the following. 25
a) Discuss the planning to transfer a technology from R&D to production.
b) Elaborate preformulation protocol for new chemical entity?
c) Explain quality control tests for plastic containers as per pharmacopeia?
d) Write a note on CDSCO guidelines for product registration.
e) Give an account on methods to improve solubility of drugs.
f) Describe critical scale up parameters processed during scale up of
parenteral formulations?
Q.2 Answer any three questions 30
a) Describe different packaging materials used in primary packaging with their
advantages and disadvantages?
b) Discuss in detail technical information to be contained in technology transfer
documentation.
c) Enlist and discuss various physicochemical properties of API studied in
preformulation studies?
d) Explain in detail the development and informational content for
investigational new drug application?
Q.3 Explain the steps involved in drug discovery and development process? 20

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 SLR-FG-20
Seat
No.
Set P
M. Pharmacy (Semester – II) (New) (CBCS) Examination April/May-2019
Pharmaceutics
MOLECULAR PHARMACEUTICS
(Nano Tech and Targeted DDS)
Day & Date: Friday, 03-05-2019 Max. Marks: 75
Time: 10:30 AM To 01:30 PM
Instructions: 1) All questions are compulsory.
2) Figure to the right indicates full marks.
Q.1 Answer any five questions: 25
a) Write a brief note on preparation of monoclonal antibodies.
b) Explain in brief about electrosomes.
c) What are the applications of Aptamers? Add a brief note on its preparation.
d) Write in brief about the need and different advantages of gene therapy.
e) Compare and contrast Liposomes and niosomes.
f) What are the different types of drug delivery systems for intranasal drug
delivery?
Q.2 Answer any three questions: 30
a) What are the different techniques available for pulmonary drug delivery?
Explain the preparation and evaluation of dry powder for inhalation.
b) Explain in brief the different techniques of gene transfer.
c) What are the advantages of formulating nanoparticulate drug delivery?
Explain with suitable examples the need of the same.
d) Explain the barriers for brain targeting. How could one achieve brain
targeting?
Q.3 What are microspheres? Explain the different techniques of its preparation. Add 20
a note on monoclonal antibodies.

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 SLR-FG-21
Seat
No.
Set P
M. Pharmacy (Semester – II) (New) (CBCS) Examination April/May-2019
Pharmaceutics
ADVANCED BIOPHARMACEUTICS AND PHARMACOKINETICS
Day & Date: Monday, 06-05-2019 Max. Marks: 75
Time: 10:30 AM To 01:30 PM
Instructions: 1) All questions are compulsory.
2) Figure to the right indicates full marks.
Q.1 Answer any FIVE of the following: 25
a) Describe about pH Partition Hypothesis.
b) Explain briefly biopharmaceutical considerations for modified drug delivery
systems.
c) What are displacement interactions in protein binding of drugs?
d) Elaborate relative and absolute availability.
e) Discuss about pharmacokinetic interactions of drug.
f) Explain briefly physiological models with advantages and disadvantages.
Q.2 Answer any THREE of the following: 30
a) Explain in detail dissolution profile comparisons.
b) Describe in detail application of pharmacokinetics in Monoclonal antibodies
and Oligonucleotides.
c) Describe in brief correlation of in vivo data with in vitro dissolution data.
d) Write a note on pH Microclimate and Intracellular pH Environment of GIT.
Q.3 Answer the following: 20
Explain in detail methods for assessing bioavailability and bioequivalence
studies.

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 SLR-FG-22
Seat
No.
Set P
M. Pharmacy (Semester – II) (New) (CBCS) Examination April/May-2019
Pharmaceutics
COMPUTER AIDED DRUG DELIVERY SYSTEM
Day & Date: Wednesday, 08-05-2019 Max. Marks: 75
Time: 10:30 AM To 01:30 PM
Instructions: 1) All questions are compulsory.
2) Figure to the right indicates full marks.
Q.1 Answer any FIVE of the following: 25
a) Describe the key elements of QbD.
b) Explain computer simulation in PK/PD using isolated tissues.
c) Describe the applications of computers in data management in clinical trials.
d) Discuss the common issues in computer ethics in pharmaceutical research.
e) Discuss use of computers in Market analysis.
f) Write a note on artificial intelligence
Q.2 Answer any THREE of the following: 30
a) Describe biopharmaceutical characterization by computational modeling of
gastrointestinal absorption simulation.
b) With suitable example explain the role of different transporters in intestinal
drug permeation.
c) Explain statistical modeling in pharmaceutical research and development.
d) Comment on ‘Biowaiver considerations’ in bioavailability and bioequivalence.
Q.3 Answer the following: 20
Explain role of computers in formulation development of pharmaceutical
microemulsion drug carriers.

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 SLR-FG-23
Seat
No.
Set P
M. Pharmacy (Semester – II) (New) (CBCS) Examination April/May-2019
Pharmaceutics
COSMETICS AND COSMECEUTICALS
Day & Date: Friday, 10-05-2019 Max. Marks: 75
Time: 10:30 AM To 01:30 PM
Instructions: 1) All questions are compulsory.
2) Figure to the right indicates full marks.
Q.1 Answer any Five of the following: 25
a) Write formulation and evaluation of moisturizing cream.
b) Define and classify perfume with appropriate examples
c) What are the general requirements for the factory premises for
manufacturing of powder?
d) Discuss cleansing care needs for face, nail and scalp
e) Write a note on factors effecting microbial preservative efficacy.
f) Highlight building blocks for formulation of toothpaste
Q.2 Answer any THREE of the following: 30
a) Write formulation and evaluation of sunscreen cream
b) Discuss hair problems and herbal remedy.
c) Define cosmetics, cosmeceuticals. Classify cosmetics with example
d) Discuss challenges in formulating herbal cosmetics
Q.3 Answer the following: 20
Give detailed account structure of skin and problems related to skin. Add a note
on cosmeceuticals remedies for different skin problems.

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 SLR-FG-28
Seat
No.
Set P
M. Pharmacy (Semester - II) (New) (CBCS) Examination April/May-2019
Pharmaceutical Quality Assurance
HAZARDS AND SAFETY MANAGEMENT
Day & Date: Friday, 03-05-2019 Max. Marks: 75
Time: 10:30 AM to 01:30 PM
Instructions: 1) All questions are compulsory.
2) Figures to the right indicate full marks.
Q.1 Answer any five questions of the following: 25
a) Write in brief about the influence of non-renewable sources on safety in an
industry.
b) Describe how soil could be a source of hazard in an industry.
c) How are effluents treated? Explain.
d) What are the sources for chemical hazards? Elaborate.
e) What is the role of electricity-passivation, ventilation, sprinkling and
proofing?
f) Why it is necessary to get trained in "hazard management"?
Q.2 Answer any three questions. 30
a) How natural resources like water and land might bring about hazards in a
chemical process industry? Discuss the remedies.
b) What is factory act all about? Discuss the significance of the same with
reference to a pharmaceutical industry.
c) What are hazards associated with toxic and oxygen displacing gases?
Discuss.
d) Discuss about the regulations related to chemical hazard, over exposure to
chemicals.
Q.3 What are the reasons for a fire hazard in an industrial process? What 20
regulations exist with regard to fire hazards? Discuss

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 SLR-FG-29
Seat
No.
Set P
M. Pharmacy (Semester – II) (New) (CBCS) Examination April/May-2019
Pharmaceutical Quality Assurance
Pharmaceutical Validation
Day & Date: Monday, 06-05-2019 Max. Marks: 75
Time: 10:30 AM To 01:30 PM
Instructions: 1) All questions are compulsory.
2) Figure to the right indicates full marks.
Q.1 Answer any FIVE of the following: 25
a) Giving relevant examples explain the role of documentation in validation.
b) What are the benefits of computer system validation?
c) Explain the critical attributes of HVAC system to be met during its validation.
d) Describe the role of preventive maintenance in working of equipments.
e) Differentiate between validation, qualification and calibration.
f) Define Intellectual Property Rights and explain different types.
Q.2 Answer any THREE of the following: 30
a) What is the scope of process validation? Describe the phases of process
validation.
b) Describe the microbiological considerations during cleaning validation.
c) Explain the important considerations in qualification of equipments.
d) Explain the method of validation of hot air oven.
Q.3 Describe the steps involved in analytical method validation. 20

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 SLR-FG-30
Seat
No.
Set P
M. Pharmacy (Semester – II) (New) (CBCS) Examination April/May-2019
Pharmaceutics Quality Assurance
AUDITS AND REGULATORY COMPLIANCE
Day & Date: Wednesday, 08-05-2019 Max. Marks: 75
Time: 10:30 AM To 01:30 PM
Instructions: 1) All questions are compulsory.
2) Figure to the right indicates full marks.
Q.1 Answer any five of the questions: 25
a) Explain the dos and don’ts while hosting the external audit.
b) Explain a note audit report.
c) Explain the role of good documentation practices in conduct of an audit.
d) Discuss the audit questionnaire.
e) What is an internal audit? Explain the important outcomes of such audits.
f) Describe the global scenario of regulatory audits in pharmaceutical industry.
Q.2 Answer any three of the questions: 30
a) Why are vendor audits conducted? Describe the step by step method of
performing vendor audit.
b) Describe the cGMP regulations governing quality audits.
c) Explain the process of auditing a production department.
d) Describe the pre-requisites attributes and qualification of a quality auditor.
Q.3 Describe the quality audit of manufacturing process and facility. 20

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 SLR-FG-31
Seat
No.
Set P
M. Pharmacy (Semester – II) (New) (CBCS) Examination April/May-2019
Pharmaceutical Quality Assurance
PHARMACEUTICAL MANUFACTURING TECHNOLOGY
Day & Date: Friday, 10-05-2019 Max. Marks: 75
Time: 10:30 AM To 01:30 PM
Instructions: 1) All questions are compulsory.
2) Figure to the right indicates full marks.
Q.1 Answer any Five of the following: 25
a) Explain evaluations tests for packaging materials
b) Discuss Process Quality Control Tests for Ointment
c) Give the Importance of Manufacturing Planning.
d) Discuss Approaches of QbD in tablet Coating Process.
e) Explain different types of granulators.
f) Distinguish between rapid mixer granulator and Rota Granulator.
Q.2 Answer any Three of the following: 30
a) Discuss plant layout of small volume parental.
b) Explain Process quality Control tests for Suspension and Emulsion
c) Elaborate Mechanism of Pelletization Techniques
d) Describe the elements of QbD
Q.3 Answer the following: 20
Discuss the design, layout and Operational facilities for ointment

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