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pharmacyQuestion paper

GTU 2021 Question Paper B.Pharm Sem:- 7 All Subject

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GUJARAT TECHNOLOGICAL UNIVERSITY
B. Pharm- SEM-VII• EXAMINATION – WINTER-2021

Subject Code:BP701TP Date: 24/11/2021
Subject Name: Instrumental Methods of Analysis
Time: 10:30 AM TO 01:30 PM Total Marks: 80
Instructions:

  1. Attempt any five questions.
  2. Make suitable assumptions wherever necessary.
  3. Figures to the right indicate full marks.
    Q.1 (a) Explain Principle and applications of HPLC 06
    (b) Discuss various Detectors and Pumps used in HPLC 05
    (c) Define: (i) Retention time (ii)Tailing factor (iii)Capacity factor (iv)Selectivity
    factor (v)Resolution

05
Q.2 (a) Explain instrumentation with Schematic diagram and applications of HPTLC 06
(b) What is gas chromatography? Explain different stationary phases used in gas
chromatography

05
(c) Enlist various detectors used in Gas chromatography. Explain any one in detail. 05
Q.3 (a) Explain the principle and Instrumentation of affinity chromatography 06
(b) Explain terms HETP, Peak asymmetry factor, Retention volume, Resolution 05
(c) Write a brief note on Nephlometry and Turbidimetry with its applications 05
Q.4 (a) Explain instrumentation with Schematic diagram and applications of HPTLC 06
(b) Define: (i) Limit of detection (ii) Accuracy (iii) Precision (iv) Rf value (v)
Calibration

05
(c) Explain in detail flame and nebulizer burner system in flame photometry 05
Q.5 (a) Write application, advantages and limitation of atomic absorption and atomic

emission spectroscopy

06
(b) Discuss about interferences in AAS. Write merits and demerits of AAS over AES 05
(c) What is the Pharmacopoeial application of IR spectroscopy, how it helpful in
identification

05
Q. 6 (a) Explain the principle, working and advantages of FTIR with labeled diagram. 06
(b) Explain HOOK’S LAW for prediction of IR frequency. Discuss factor affecting
IR frequency.

05
(c) Draw a well labeled diagram of Spectrofluorimeter. Write an instrumentation
advantages, Limitation and application of fluorescence spectroscopy

05
Q.7 (a) Write a note on Radiation Source, detectors and monochromators used in UV –

VIS spectrophotometer

06
(b) Discuss the effect of solvent and pH on spectral characteristic in UV visible
spectroscopy

05
(c) Explain the terms with reference to EMR: Diffraction, Reflection and
Refraction

05


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Seat No.: _ Enrolment No. _____
GUJARAT TECHNOLOGICAL UNIVERSITY
B.Pharm. – SEMESTER– VII• EXAMINATION – SUMMER -2021
Subject Code: Instrumental Methods of Analysis Date: 03/08/2021
Subject Name: BP701TP
Time: 10:30AM TO 01:30PM Total Marks: 80
Instructions:

  1. Attempt any five questions.
  2. Make suitable assumptions wherever necessary.
  3. Figures to the right indicate full marks.
    Q.1 (a) Give brief account on (i) Photomultiplier tube (ii) Auxochromes 06
    (b) State and derive Beer-Lambert’s Law 05
    (c) Write a detail note on UV-Spectrophotometry 05
    Q.2 (a) Describe the factors affecting fluorescence 06
    (b) Explain the terms (i) Quenching (ii) Singlet, doublet and triplet electronic states 05
    (c) Write a detail note on sample handling in IR spectroscopy 05
    Q.3 (a) Explain the working principle of FTIR spectroscopy.
    Explain the difference between dispersive IR and FTIR.

06

(b) Explain with example- Fundamental modes of vibrations in poly atomic
molecules

05
(c) Give a brief account on (i) Golay cell (ii) Bolometer 05
Q.4 (a) Write a brief note (i) Applications of atomic absorption spectroscopy in

Pharmaceutical science (ii) Nephelometry

06
(b) Explain the working principle of flame photometer with neat diagram 05
(c) What are the types of paper chromatography?
Give the applications of paper chromatography in pharmaceutical science

05
Q.5 (a) Explain the terms (i) HETP (ii) Tailing (iii) Resolution 06
(b) Explain the basic principle and applications of zone electrophoresis 05
(c) Discuss about derivatization in gas chromatography 05
Q. 6 (a) Explain the principle of HPLC.

Explain its applications in pharmaceutical science

06
(b) Differentiate between HPLC and GC 05
(c) Give brief account on resins used in ion exchange chromatography. 05
Q.7 (a) Write short note (i) Flame ionization detector (ii) Gel chromatography 06
(b) Write a short note on stationary phase and mobile phase used in HPLC 05
(c) Explain the basic principle of affinity chromatography.
Enumerate applications of affinity chromatography.

05

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Seat No.: _ Enrolment No. _____
GUJARAT TECHNOLOGICAL UNIVERSITY
B.Ph. – SEMESTER–VII • EXAMINATION – WINTER -2021

Subject Code:BP702TT Date: 26/11/2021
Subject Name: Industrial Pharmacy II
Time: 10:30 AM TO 01:30 PM Total Marks: 80
Instructions:

  1. Attempt any five questions.
  2. Make suitable assumptions wherever necessary.
  3. Figures to the right indicate full marks.
    Q.1 (a) Define Pilot plant and scale up. Discuss importance of pilot plant study. 06
    (b) Discuss various levels of changes under distinct headings of any two changes in
    context to SUPAC – Immediate Release Solid Oral Dosage Form.

05
(c) What is pilot plan study? Discuss objective and steps for pilot plan scale up
study.

05
Q.2 (a) Write a note on Certificate of Pharmaceutical Product (COPP). 06
(b) Describe documentation requirement for transfer the technology from R & D to
manufacture level.

05
(c) Discuss SUPAC guidelines for semisolid dosage forms with reference to the
components and composition changes.

05
Q.3 (a) What is Investigational New Drug (IND) Application? Explain Requirement

and types of an IND.

06
(b) Write a note on ANDA. 05
(c) Explain Clinical trial Management Studies in details. 05
Q.4 (a) Explain ISO 9000 series of quality systems standards for pharmaceutical

product.

06
(b) Write a note on Out of Specifications (OOS). 05
(c) Explain purpose, benefits and elements Total Quality Management. 05
Q.5 (a) Explain review process for New Drug Application (NDA). 06
(b) Write a note on scope and organization management as per WHO guideline. 05
(c) Describe steps in technology transfer process for pharmaceutical industry. 05
Q. 6 (a) What is CDSCO? Explain function of CDSCO in details. 06
(b) Write a note on Certificate of Pharmaceutical Product (COPP). 05
(c) Explain Regulatory requirements and approval procedures for New Drugs in
India.

05
Q.7 (a) Write a note on Change control in pharmaceutical company with examples. 06
(b) Explain Organization and Responsibilities of State Licensing Authority in India. 05
(c) How to Data Presentation for FDA Submissions? Explain in details. 05


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Seat No.: _ Enrolment No. _____
GUJARAT TECHNOLOGICAL UNIVERSITY
B.Pharm – SEMESTER– VII• EXAMINATION – SUMMER -2021

Subject Code: BP702TT Date: 04/08/2021
Subject Name: Industrial Pharmacy II
Time: 10:30AM TO 01:30PM Total Marks: 80
Instructions:

  1. Attempt any five questions.
  2. Make suitable assumptions wherever necessary.
  3. Figures to the right indicate full marks.
    Q.1 (a) Write a detailed note on various level of changes in SUPAC guidelines. 06
    (b) Discuss pilot plant scale up consideration for oral liquids. 05
    (c) Discuss general consideration for space requirement for scale up techniques. 05
    Q.2 (a) Discuss various documentation required for changes is batch size as per

SUPAC guidelines.

06
(b) Introduce platform technology with respect to pilot plant scale up technique. 05
(c) What is Certificate of Pharmaceutical Product? 05
Q.3 (a) Discuss the scope of WHO guidelines on transfer of technology in

pharmaceutical manufacturing.

06
(b) Briefly describe technology transfer protocol. 05
(c) Write a note on various technology transfer agencies in India. 05
Q.4 (a) Discuss confidentiality agreement in Technology Transfer. 06
(b) Write in brief about Quality Risk Management with respect to Technology
Transfer.

05
(c) Describe in brief responsibilities of CDSCO. 05
Q.5 (a) What is IND Application. Discuss Emergency use IND Application. 06
(b) Convey historical overview of Regulatory Affairs. 05
(c) Briefly describe Management of Clinical trials. 05
Q. 6 (a) Describe the responsibility of regulatory affairs professionals. 06
(b) Describe the importance of Investigator’s Brochure. 05
(c) Briefly discuss approval procedures for new drugs. 05
Q.7 (a) What is Six Sigma? Discuss the importance of Six Sigma concept. 06
(b) Write a brief note on ISO 9000 series of quality standards 05
(c) Write a note on procedure for change control. 05


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Seat No.: _ Enrolment No. _____
GUJARAT TECHNOLOGICAL UNIVERSITY
B.Pharm. – SEMESTER -VII– • EXAMINATION – WINTER -2021
Subject Code: BP703TT Date:29/11/2021
Subject Name: Pharmacy Practice
Time: 10:30 AM TO 01:30 PM Total Marks: 80
Instructions:

  1. Attempt any five questions.
  2. Make suitable assumptions wherever necessary.
  3. Figures to the right indicate full marks.
    Q.1 (a) Explain following terms:

a. Excessive pharmacological effects
b. Secondary pharmacological effects
c. Idiosyncrasy
d. Allergic drug reactions
e. Genetically determined toxicity
f. Withdrawal reaction

06

(b) Define hospital. Give detailed classification of hospital. 05
(c) Discuss Pharmacokinetic Drug Interactions with examples. 05
Q.2 (a) Mention the steps in patient counseling. Explain role of pharmacist in patient

counseling.

06
(b) Explain organization and structure of retail and whole sale drug store. 05
(c) Discuss the duties and responsibilities of hospital pharmacist. 05
Q.3 (a) Discuss the different types of outpatient services for the drug distribution

system in hospital.

06

(b) Differentiate between Hospital formulary and drug list. Write a note on
preparation & revision of the formulary.

05

(c) What is therapeutic drug monitoring? Explain its importance with suitable
examples.

05
Q.4 (a) What is PTC? Give the structure and functions of PTC. 06
(b) Write methods to detect medication non-compliance. Which measures are
required to improve patient compliance?

05

(c) Why there is a need for the patient medication history interview? Give the
format of medication interview forms.

05

Q.5 (a) Define budget. Enlist divisions of Budget. Explain budget preparation &

implementation in hospital pharmacy.

06
(b) Explain the importance of communication skills with patients and prescribers. 05
(c) Write code of ethics for community pharmacist. 05
Q. 6 (a) Write functions and responsibilities of clinical pharmacist. 06
(b) Explain different methods of storage of drug material in retail drug store. 05
(c) Enlist different techniques of inventory control. Explain ABC and VED
analysis method in brief.

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05
Q.7 (a) Write sources of drug information. Discuss various applications of computer in

hospital pharmacy.

06
(b) Describe in detail about various hematological test. 05
(c) Describe the role of pharmacist in the education and training program in
hospital.

05


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Seat No.: _ Enrolment No. _____
GUJARAT TECHNOLOGICAL UNIVERSITY
B.Pharm – SEMESTER–VII • EXAMINATION – SUMMER -2021
Subject Code:BP703TT Date: 05/08/2021
Subject Name: Pharmacy Practice
Time:10:30am to 01:30pm Total Marks: 80
Instructions:

  1. Attempt any five questions.
  2. Make suitable assumptions wherever necessary.
  3. Figures to the right indicate full marks.
    Q.1 (a) Define hospital. Give detailed classification of hospital. 06
    (b) Discuss the functions of hospital pharmacy. 05
    (c) Explain the methods for detecting drug interactions. 05
    Q.2 (a) Discuss organization and structure of retail drug store. 06
    (b) Explain drug distribution to in-patients in typical hospitals. 05
    (c) Explain the contents of hospital formulary. 05
    Q.3 (a) Give the structure and functions of pharmacy and therapeutic committee. 06
    (b) Discuss the factors to be considered during the therapeutic drug monitoring. 05
    (c) Discuss the role of pharmacist in medication adherence. 05
    Q.4 (a) Define patient counselling. Discuss steps involved in patient counselling. 06
    (b) Explain various sources of drug information. 05
    (c) Discuss the role of pharmacist in education and training program in hospital. 05
    Q.5 (a) Explain the functions and responsibilities of clinical pharmacist in clinical

pharmacy

06
(b) Discuss the role of communication skills in communication with patients. 05
(c) Discuss about rationale use of common over the counter medications 05
Q. 6 (a) Discuss about Indian scenario for therapeutic drug monitoring. 06
(b) Explain the different methods of storage of drug materials in retail drug store. 05
(c) Explain the liver functions test. 05
Q.7 (a) Explain the procedure for purchasing of drugs. 06
(b) Discuss the responsibilities and functions of hospital pharmacist. 05
(c) Explain the revision of formulary in hospital. 05


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Seat No.: _ Enrolment No. _____
GUJARAT TECHNOLOGICAL UNIVERSITY
B.Pharm. – SEMESTER -VII– • EXAMINATION – WINTER -2021
Subject Code: : BP704TT Date:01/12/2021
Subject Name: Novel Drug Delivery System
Time: 10:30 AM TO 01:30 PM Total Marks: 80
Instructions:

  1. Attempt any five questions.
  2. Make suitable assumptions wherever necessary.
  3. Figures to the right indicate full marks.
    Q.1 (a) Explain the terms delayed release, extended release and controlled release. Discuss

advantages of controlled release drug delivery systems.

06
(b) Classify controlled release drug delivery systems. Describe matrix systems. 05
(c) Describe the physicochemical properties of drug molecule required for controlled drug
delivery system.

05

Q.2 (a) Explain glass transition temperature of polymer. Describe smart polymers with examples. 06
(b) Differentiate between microsphere and microcapsule. Discuss advantages and limitations
of microencapsulation.

05
(c) Enlist methods of microencapsulation. Describe spray drying-spray congealing method. 05
Q.3 (a) What is mucosal drug delivery? Describe theories of muco/bio-adhesion. 06
(b) Discuss formulation approaches for buccal drug delivery systems. 05
(c) What is transdermal drug delivery system (TDDS)? Describe matrix formulation
approach for TDDS.

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05

Q.4 (a) What is implantable drug delivery? Describe Alzet osmotic pump with diagram. 06
(b) Describe the factors affecting permeation of drug through barrier of skin. 05
(c) What is targeted drug delivery? Describe passive and active targeting in detail. 05
Q.5 (a) Explain gastro-retentive drug delivery system (GRDDS). Describe advantages and

limitations of GRDDS.

06
(b) Enlist approaches for gastric retention. Discuss high density and raft forming approaches. 05
(c) What are nanoparticles? Describe pharmaceutical applications of nanoparticles. 05
Q. 6 (a) Compare and contrast metered dose inhalers and dry powder inhalers for drug delivery. 06
(b) Explain first, second and third- order targeting. Discuss advantages and disadvantages
of liposomes as a drug carrier.

05
(c) Explain monoclonal antibodies. Describe their advantages, limitations and applications. 05
Q.7 (a) Name the intraocular barriers to drug permeation. Describe methods to overcome intra

ocular barriers of the eye.

06
(b) What are intrauterine devices (IUDs)? Discuss hormone releasing IUDs. 05
(c) What is ophthalmic in situ gel? Describe different type of ocular inserts. 05
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Seat No.: _ Enrolment No. _____
GUJARAT TECHNOLOGICAL UNIVERSITY
B.Pharm – SEMESTER VII– • EXAMINATION – SUMMER -2021
Subject Code:BP704TT Date: 06/08/2021
Subject Name: Novel Drug Delivery Systems
Time:10:30AM TO 01:30PM Total Marks: 80
Instructions:

  1. Attempt any five questions.
  2. Make suitable assumptions wherever necessary.
  3. Figures to the right indicate full marks.
    Q.1 (a) State the physico chemical properties influencing controlled release 06
    (b) Name the different controlled release delivery systems and differentiate one
    from each other

05
(c) Define: controlled, sustained, delayed, time and prolonged releases 05
Q.2 (a) Classify polymers based on sources. Explain Acrylic polymers in detail 06
(b) Explain different methods of formulating Nanoparticles 05
(c) Give a brief account on biodegradable polymers 05
Q.3 (a) Differentiate microsphere and microcapsule. Explain solvent evaporation

method of microsphere formulation

06

(b) Differentiate buccal and sublingual route. What are the basic excipients
required for formulating transmucosal delivery?

05
(c) Write short notes on tests to determine bioadhesive strength. 05
Q.4 (a) Comment on suitability of drug candidates for transdermal delivery with few

examples.

06
(b) Discuss different parameters to be evaluated for transdermal patches. 05
(c) Write short notes on Dental implants 05
Q.5 (a) Give a brief account on Floating drug delivery systems. 06
(b) Write short notes on applications of GRDDS. 05
(c) How the particle size plays role in pulmonary delivery and methods of
controlling the size?

05
Q. 6 (a) Define Liposome. Write methods of formulating SUVs. 06
(b) Discuss the advantages of Targeted delivery. 05
(c) Discuss ALZET type of pump. 05
Q.7 (a) What are the barriers of ocular delivery and methods of overcoming the same? 06
(b) Write short notes on contraceptive IUDs. 05
(c) Justify: MoAbs are targeted delivery systems. 05


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Seat No.: _ Enrolment No. _____
GUJARAT TECHNOLOGICAL UNIVERSITY
B.Ph. – SEMESTER–VII • EXAMINATION – WINTER -2021

Subject Code: BP706TT Date: 03/12/2021
Subject Name: Quality Assurance
Time: 10:30 AM TO 01:30 PM Total Marks: 80
Instructions:

  1. Attempt any five questions.
  2. Make suitable assumptions wherever necessary.
  3. Figures to the right indicate full marks.
    Q.1 (a) Define & explain the concept of QA, QC and GMP. 06
    (b) Write detailed account on TQM. 05
    (c) Describe ISO 9000 in brief. 05

Q.2 (a) Discuss briefly the overview of QSEM guidelines of ICH. Discuss specially Q-
series guidelines.

06
(b) Explain importance of Quality by design. Discuss elements of QBD program. 05
(c) Discuss principles and procedures for NABL accreditation. 05
Q.3 (a) Discuss responsibilities of personnel in Pharmaceutical organization. 06
(b) Write the importance of training, hygiene and records of personnel in
Pharmaceutical organization.

05
(c) Explain design, construction and plant layout of sterile manufacturing plant. 05
Q.4 (a) Write detailed account on quality control test for containers of various dosage

forms.

06
(b) Write a short note on Batch Formula Record & Master Formula Record. 05
(c) Discuss selection and purchase specifications of equipments. 05
Q.5 (a) Discuss evaluation of complaints and Handling of return goods. 06
(b) Write descriptive note on SOP. 05
(c) Discuss: Quality Audit, Quality Review and Quality documentation. 05
Q. 6 (a) Write importance and scope of validation. Discuss qualification of UV-Visible

Spectrophotometer.

06
(b) Discuss general principles of Analytical method validation. 05
(c) Write details on DQ, IQ, OQ and PQ. 05
Q.7 (a) Write brief account on GLP. 06
(b) Discuss protocols, Records and Reports for Conduct of a Nonclinical
Laboratory study.

05
(c) Write note on Good warehousing practice and material management. 05


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Seat No.: _ Enrolment No. _____
GUJARAT TECHNOLOGICAL UNIVERSITY
B. Pharm. – SEMESTER – VII • EXAMINATION – SUMMER -2021
Subject Code: BP706TT Date: 07/08/2021
Subject Name: QUALITY ASSURANCE
Time: 10:30 AM TO 01:30 PM Total Marks: 80
Instructions:

  1. Attempt any five questions.
  2. Make suitable assumptions wherever necessary.
  3. Figures to the right indicate full marks.
    Q.1 (a) Enlist analytical method validation parameters for assay of drug products.
    Describe LOQ and accuracy with their evaluation techniques as per ICH.

06
(b) Discuss validation of UV – Visible spectrophotometer. 05
(c) What is pharmaceutical waste? Write a note on waste disposal procedures and
the records to be kept for them.

05

Q.2 (a) What are the tools of QbD? Discuss briefly. 06
(b) Differentiate: Batch Formula Record and Master Formula Record. 05
(c) Write in brief about handling of returned goods with suitable examples. 05
Q.3 (a) Describe the advantages and disadvantages of plastic containers with that of

glass container. Discuss QC tests carried out on plastic containers.

06
(b) Write objectives of GLP? Discuss in brief the key points in GLP. 05
(c) What is ISO? Write benefits of ISO. Describe steps for registration in general. 05
Q.4 (a) What is QA? Describe concepts and differences of QA and QC in brief. 06
(b) Write a brief note on TQM. 05
(c) Why product to be recall? Write briefly about procedures to be followed for
recalling a product.

05

Q.5 (a) Write benefits of laboratory accreditation. Explain principles of NABL

accreditation?

06
(b) Explain the term: Storage. Discuss briefly good warehousing practices for
different materials used in pharmaceutical industry.

05
(c) Write a note on purchase specifications for equipment. 05
Q. 6 (a) Discuss about maintenance of sterile areas in premises. 06
(b) Write a note on ICH stability testing guideline. 05
(c) What is ICH? Give brief overview of QSEM code assigned to ICH guideline.
Enlist categories in which process of harmonization implemented by ICH.

05
Q.7 (a) What is QbD? Discuss QTPP and CQA. 06
(b) Write in brief about SOP. 05
(c) Discuss about responsibilities and training guideline for personnel in an
organisation.

05

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