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4

Seat Number PANKH-25

0 55
BP-601T

2 4 0
Medicinal Chemistry-III
(736601)
ANKH-25
Total Pages : 2]
Time : 3 Hours Max Marks : 75

0 5 5
Note : (1) Do not write anything on question paper0except Seat No.
2 4
(2)
5 5
Graph or diagram should be drawn with the black ink pen being used
0 paper or black HB pencil.
0
for4writing
2
(3) Students should note, no supplement will be provided.

(4) Figures to the right indicate full marks.


0 55
1. Write the answer of the following : 40 20
2
(i) What is the mutual prodrug ?

(ii) Give the synthesis of ciprofloxacin.

(iii)
5
Write the structure and uses of any two pencillins.
5
(iv)
24 00
Give examples for Fluoroquinolones.

(v) Give the mechanism of action of Anthelmintics.


0 5 5
240(vi)5 Give the mechanism of Beta lactam antibiotics.
0 0 5 5
0 5
(vii) Write the structure and uses of 2 4
Amantadine and Cycloserine.

240 (viii) Define prodrug and enlist its types.


(ix) Comment on combinatorial chemistry.

(x) Give the synthesis of Acyclovir.


P.T.O.

PANKH-25
4

2. Attempt any two of the following : 20

(i) 55
Define and classify Antibiotics with examples.
0
(ii) 240
Classify sulphonamides and give the synthesis of sulphamethoxazole

ANKH-25 and Dapsone.

(iii) Define QSAR and explain the methods of QSAR.


0 55
3. Attempt any seven out of the following : 2 40 7×5=35

(i) 0 5 5
Describe the applications of prodrug.

(ii) 2 40
Classify anti-malarial drugs with examples.

(iii) Write the synthesis of Chloamphenicol and Metronidazole.

(iv)
0 5 5
Explain briefly about anti-protozoal agents.
40
(v) Write a note on Antifungal 2
antibiotics.

(vi) Classify Anti-tubercular agents with examples.

(vii) Write the various parameters of QSAR.

5 5
(viii) Write a note on Cephalosporins.

(ix) 24 00
Write the SAR of Quinolones.

0 5 5
240 5 0 0 55
0 5 2 4
240

PANKH-25 2

PANKH-25
4

Seat Number PANKH-29

0 55
BP-602T

24 0Pharmacology-III
(736602)
ANKH-29
Total Pages : 6]
Time : 3 Hours Max. Marks : 75

0 55
Note : (1)
(2) 2 40
Do not write anything on question paper except Seat No.
Graph or diagram should be drawn with the black ink pen being
0 5 5
(3)
40
used for writing paper or black HB pencil.
2Students should note, no supplement will be provided.
(4) All questions are compulsory.

1. Multiple Choice Questions (MCQs) :


5 5 20
0 is a potent inducer of hepatic
(i) 4 0
Which one of the following antibiotics
2
drug metabolizing enzymes ?

(a) Ciprofloxacin (b) Cyclosporine

(c) Erythromycin (d) Rifampin

5 5
00
(ii) Cyclosporine is used for :

(a) 24
Allergies

0 5 5 (b) Prevention of transplant rejection

240 5 5
(c) Steroid deficiency
0 0 5
0 5 (d) Treating lead poisoning
2 4
0
24 (iii) Chloramphenicol is the drug of choice in :
(a) Staphylococcal infection (b) Salmonella infection

(c) Viral infection (d) Amoebic dysentery

P.T.O.

PANKH-29
4

(iv) Why benzyl penicillin is the ineffective in gram negative

infections ?
0 55
(a)
240by penicillanase of gram negative organisms.
Is destroyed

ANKH-29 (b) Gram negative organisms do not utilise Dalanine whose

incorporation is inhibited by benzyl penicillin.


0 55
(c)
40 of gram
The lipoprotein-peptidoglycan cell wall
2
negative

0 5 5
organisms prevent entry of penicillin.

(d) 40
2 All of the above

(v) Drug of choice of ringworm infection is :

(a) Griseofulvin (b) Amphoterin-B


0 5
5 Neomycin
(c) Nystatin
240 (d)

(vi) Tetracycline is stored in the body in :

(a) protein bound form (b) hair, nails and skin

(c) muscular tissues (d) bones

5 5
(vii)
00
In cell targeted suicide mode of gene therapy for cancer the prodrug
24
used is :

5 5 (a) Gancyclovir
0 (c) Ara c/m
(b) Acyclovir

4
2 50 (d) 5
All of5these
4 0 0
0 0 5(viii) The antimalarial agent that can be used
2 during pregnancy is :
24 (a) Halofantrine (b) Chloroguanide

(c) Mefloquine (d) Primaquine

PANKH-29 2

PANKH-29
4

(ix) Vinca alkaloid exert antitumor activity by :

(a)
55
Activating tropoisomerase II to cause breaks in DNA.
0
(b) 240
Crosslinking DNA strands.

ANKH-29 (c) Inhibiting DNA mediated RNA synthesis.

(d) 5
Inhibiting polymerization of tubulin to form intracellular
0 5
microtubules.
2 40
(x) 5 5
The virus directed reverse transcriptase enzyme is inhibited by :
0
2
(a) 40Amantadine (b) Zidovudine

(c) Vidarabine (d) Acyclovir

(xi) Passive immunisation involves :


0 55
(a) Live immunogens
2 40
(b) Stimulation of antibody formation

(c) Use of antigens

(d) Use of preformed antibodies


5 5
0 occur as a side effect of :
(xii) Gynaecomastia 0
can
2 4
(a) Bromocriptine (b) Levodopa

0 5 5(c) Famotidine (d) Cimetidine

240(xiii)
5 0 0 5 5
The most effective antiemetic for controlling cisplatin induced vomitting

0 5 2 4
240
is :

(a) Prochlorperazine (b) Ondansetron

(c) Metoclopramide (d) Promethazine

PANKH-29 3 P.T.O.

PANKH-29
4

(xiv) The antiasthma drug which cannot be administerted by inhalation


is :
0 55
(a)
240
Theophylline (b) Ipratropium bromide

(c) Budesonide (d) Terbutaline


ANKH-29 (xv) Muscarinic manifestations of organophosphates are treated with :

(a) Atropine (b) 0


Nicotine 55
(c) Morphine (d) 240
Naloxone

0 5 5
(xvi)
40
What is circadian rhythm ?
2
(a) Cycles shorter than a day

(b) Cycles lasting for about 24 hours.

(c) Cycles longer than 24 hours.


0 55
(d) None of the above. 2 40
(xvii) Absolute contraindication of gastric lavage include :

(a) Coma (b) Sulphuric acid

(c) Convulsions (d) All of these

0 5 5
4 0
(xviii) Bisacodyl frequently can cause :

(a) Skin 2rashes (b) Abdominal cramps

0 5 5 (c) Dizziness (d) Constipation

4
2 50(xix) Antitussives acts by : 55
4 0 0
0 0 5 (a) Liquifying bronchial secretions 2
24 (b) Raising threshold of cough centers

(c) Reducing cough inducing impulses from the lungs

(d) Both (b) and (c)


PANKH-29 4

PANKH-29
4

(xx) Sulphamethizole is principally used for :

(a)
0
Topical infection55
(b) 2 40
Systemic infection
ANKH-29 (c) Occular infection

0 55
(d) Urinary infection
240
2.
5 5
Long Answers type questions (solve any two) :
0
20

(i) 24 0
Explain in brief peptic ulcer, classify drugs used in peptic ulcer and

write in brief MOA and side effects of Pantoprazole.

(ii)
55
Explain in detail general principles of treatment of poisoning.
0
(iii) 4 0
2 of malignancy.
Explain in detail chemotherapy

3. Short answers type (solve any seven) : 35

(i) What is antibiotic resistance ? Explain the process of development of

resistance. 5 5
24 00
(ii) Write a note on Antitubercular agents.

5 5What is MOA of Pencillin ? Explain its pharmacokinetics and adverse


(iii)
0
240 5 effects associated with it. 0 0 55
0 4
5(iv) Write a note on Immunosuppressants2with their applications.
240
(v) Define and classify laxatives and purgatives. Write MOA of stimulant

purgatives.

PANKH-29 5 P.T.O.

PANKH-29
4

(vi) Write a note on Antiviral drugs.

(vii) 0 55
Write in brief clinical symptoms and management of Barbiturates

poisoning.
2 40
ANKH-29 (viii) What is bronchial asthma ? Classify anti-asthmatic agents and add an

0 55
account on B2 agonist.
2 40
(xi)
5 5
Explain biological clock and its significance in chronotherapy.
0
2 40

0 55
2 40

5 5
24 00

0 5 5
240 5 0 0 55
0 5 2 4
240

PANKH-29 6

PANKH-29
4

Seat Number PANKH-33


0 55
BP-603T

240 Drug
Herbal Technology
(736603)
ANKH-33
Total Pages : 7]
Time : 3 Hours Max Marks : 75
0 5
5 Seat No.
Note : (1) Do not write anything on question paper 0 except
24
Students 5
(2)
0 5 should note, no supplement will be provided.

(3) 2All40questions are compulsory.


(4) Figures to the right indicate full marks.

(5)
0 55
Graph or diagram should be drawn with the black ink pen being
4 0
used for writing paper or2black HB pencil.

1. (A) Multiple Choice Questions : 20

(i) Garlic contains type of compounds :

5 5
00
(a) Alkaloids (b) Surface compounds

(c)
4
2Tannins (d) Flavourds

0 5 5 (ii) The Biological source and family of Fenugreek is :

240 5 (a) 0 55
Zinger offincinalis, Zingiberaceae
0
0 5 2 4
240 (b) Panax ginseng, Araliaceae

(c) Trigonella Foenum–graecum, Fabaceae

(d) Catharanthus roseus, Apocyanaceae

P.T.O.

PANKH-33
4

(iii) Of the following which is Herbal Excipient ?

(a) Agar
0 55 (b) Gum-acasia

Aloe40
(c)
2 (d) Both (a) and (b)

(iv) The sources of Herbs are :


ANKH-33
(a) Higher plants (b) Microbes

0 55
(c) Marine organisms
40
(d) All of these
2
(v)
5
Asavas is :
0 5
2 40(a) Mixture of powdered herbs and minerals
(b) Polyherbal semisolid formulation

(c) It is well known as traditional fermented biomedicine

(d) None of the above


0 55
(vi) Herb may be defined 2 4
as :
0
(a) Any part of any plant used as aroma, flavouring or

medicine

(b) It may be fruit, bark, flower, leaf, root as well as harwerdy


5 5
00
plant
4 (a) and (b)
2Both
(c)

0 5 5 (d) None of the above

240 5 (vii) Herbal drug preparation may contain :


0 0 55
0 5 (a) Extracts
2 4
240 (b) Tinctures

(c) Essential oils

(d) All of the above

PANKH-33 2

PANKH-33
4

(viii) Herbal medicine may be :

(a) 55
Plant or mixture of plant extracts
0
(b) 240
Use to treat illness and promote health

ANKH-33 (c) None of the above

(d) Both (a) and (b)


0 55
(ix) Homoeopathy is : 2 40
0 5 5
2 40(a) A system of medical practice that aims to combat disease
by use of drugs or surgery

(b) A medical system based on belief that body can cure

0 55
itself
2 40
(c) An ancient system of medicine prevalent in South India

(d) None of the above

(x) Pest may be defined as :

5 5
(a)
00
It is an insect or animal that destroy plants/animals/foods
4
2Destructive
(b) or harmful insect

0 5 5 (c) None of the above

240 5 (d) Both (a) and (b)


0 0 55
0 5 (xi) 2 4
240 Give examples of Antioxidant in skin care :

(a) Vitamin C (b) Vitamin E

(c) Both (a) and (b) (d) EPA and DHA

PANKH-33 3 P.T.O.

PANKH-33
4

(xii) Phytosomes may be defined as : :

(a)
55
Non-ionic surfactant based vesicle
0
It is40
(b)
2 a complex of a natural active ingredients and
ANKH-33 phospholipid

(c) It is a suspension of fine solid particle/liquid droplets

0 55
(d) None of the above
2 40
(xiii) IPR is :
0 5 5
2 40(a) A Intellectual property rights
(b) An assignment of property rights through patents or

copyright

(c) Both (a) and (b) 0 55


2 4 0
(d) None of the above

(xiv) What is Schedule T :

(a) Related to GMP (b) Related to GLP

(c) 5
Related to patents
5 (d) Biopiracy

(xv)
24 00
DCC and DTAB is :

(a) Drug centralised Controller and Drug Therapeutic

0 5 5 Advisory Board

240 5 (b)
0 0 55
Drug Consultative Committee and Drug Technical

0 5 2 4
240 Advisory Board

(c) Both (a) and (b)

(d) None of the above

PANKH-33 4

PANKH-33
4

(xvi) Diluents may be defined as :

(a)
0 55
They act as filters in tablets to increase wright and improve

2 40
uniformity

ANKH-33 (b) Solid, insoluble particles that pass through gas unabsorbed

(c) Both (a) and (b)


0 55
(d) None of the above 2 40
0 5 5
(xvii) 0
24
Side effects of Garlic is :

(a) Burning Sensation in stomach

(b) Nausea
0 55
(c) Gas
2 40
(d) All of the above

(xviii) Ashwagandha may contain :

(a) Steroidal lactone (b) Alkaloids


0 5 5
240
(c) Both (a) and (b) (d) None of these

(xix) Probiotics may cantain :

0 5 5
240 5 5
(a) Live bacteria and yeasts that provide health benefits

0 5
0tract
0 5 (b) 4
Promoting a healthy digestive
2
240 (c) Promting a healthy immune system

(d) All of the above

PANKH-33 5 P.T.O.

PANKH-33
4

(xx) Honey is :

(a) 55
A sweet, viscous food substance made by bees insects
0
(b) 240
A perennial harbaceous plant secretion of dandelion

ANKH-33 (c) Both (a) and (b)

(d) None of the above


0 55
2. Answer any two : 2 40 20

(i) 0 5 5
Explain basic principle involved in Ayurveda and Siddha. Write short
2 40
note on Churna.

(ii) What are Nutraceuticals ? Discuss in health benefits and role of

55
Nutraceuticals in disease. Write a note on Amla.
0
(iii) Discuss on patenting 4 0
and 2Regulatory Requirements of natural

products.

3. Answer any seven : 35

(i) 5
Discuss in brief Harbal drug industry, with present scope and future
5
prospects.
24 00
(ii) Write short note on WHO guideline for assessment of harbal drugs.

0 5 5Define Harbal excipients. Write about Binders and Diluents.


240(iv)5 Write in brief about possible side effects and
(iii)
5 5
0 interactions of Ginseng
5 2 4 0
0 0
24 and Ephadra.

(v) Write preparation and standardisation of Bhasma.

(vi) Discuss in short about Spirulina as Nutraceuticals.

PANKH-33 6

PANKH-33
4

(vii) Explain two methods of pest management in medicinal plants.

(viii) Write short notes on :


0 55
(a) 240
Biopesticides

ANKH-33 (b) Unani systems.

(ix)
5
Write about selection, authentication and processing of herbal
0 5
material.
240
0 5 5
2 40

0 55
2 40

5 5
24 00

0 5 5
240 5 0 0 55
0 5 2 4
240

PANKH-33 7 P.T.O.

PANKH-33
4

Seat Number PANKH-37


0 55
BP-604-T

240 (736604)
Biopharmaceutics and Pharmacokinetics

ANKH-37
Total Pages : 4]
Time : 3 Hours Max. Marks : 75
0 5
5 Seat No.
Do not write anything on question paper0except
Note : (1)
2 4
Graph or 5
(2)
0 5 diagram should be drawn with the black ink pen being
used0for writing paper or black H.B. pencil.
4
2Students should note, no supplement will be provided.
(3)

(4) All questions are compulsory.


1. (A) Multiple choice questions :
0 55 10
(i) 4
2 :
Bioavailability is defined
0
as
(a) Rate and extent of drug metabolism
(b) Rate and extent of drug distribution
(c) Rate and extent of drug elimination
(d) 5 5
Rate and extent of drug absorption
(ii)
24 00
Which of the following equations is right for rate of excretion ?
(a) Rate of excretion = rate of filtration – rate of secretion

0 5 5 + rate of reabsorption

240 5 0 55
amount of drug in the body
0
0 5 (b)
2 4
Rate of excretion = plasma drug concentration

240 (c) Rate of excretion = rate of filtration + rate of secretion

– rate of reabsorption

(d) Rate of excretion = rate of filtration + rate of secretion

P.T.O.

PANKH-37
4

(iii) Which of the following is not a physiological barrier to distribution


of drugs ?
0 55
Blood 0
(a)
2 4 brain barrier (b) Blood skin barrier

(c) Blood CSF barrier (d) Blood placental barrier


ANKH-37 (iv) Non-linear pharmacokinetic is also called as :

(a) Mixed order kinetics


0 55
(b) Capacity limited kinetics 2 40
0
(c)5 5Dose dependent kinetics
2 40(d) All of the above

(v) In Michaelis-Menten equation, when Km << C, the equation


becomes :
0 55
(a)
dc VmaxC
40
2 (b) dc VmaxC
dt Km C dt Km

dc C dc
(c) dt Km C (d) Vmax
dt
(vi) Which route of drug administration is most likely to lead to the

5 5
first pass effect ?

(a) 4 00
2Sublingual (b) Oral

(c) Intravenous (d) Intramuscular

0 5 5(vii) For the calculation of the valume of distribution (Vd) one must

240 5 take into account :


0 0 55
0 5 (a) 2
Plasma drug concentration 4
240 (b) Concentration of substance in urine

(c) Therapeutic width of drug action

(d) A daily dose of drug


PANKH-37 2

PANKH-37
4

(viii) A study of what the body does to the drug is :

(a)
55
Pharmacodynamics
0
(b) 2 40
Pharmacokinetics

ANKH-37 (c) Pharmacotherapeutics

(d) First-pass metabolism


0 55
(ix)
240concentration of drug
The time period for which the plasma

5 5 above the MEC level is called :


remains
0
0
24 (a) Onset of action (b) Intensity of action

(c) Therapeutic index (d) Duration of action

(x) Dose ratio is :


5 5
0 dose
(a)
2 4 0
Loading dose/maintenance

(b) Maintenance dose/loading dose

(c) Loading dose/maintenance dose × 100

(d) None of the above


5 5
0 (2 marks each) :
(B)
2 4 0
Answer the following 10

(i) Define biopharmaceutics.

0 5 5(ii) Enlist the patient related factors influencing GI absorption of

240 5 drug.
0 0 5 5
0 5 (iii) 2 4
240 What are the objectives of bioavailability studies ?

(iv) What is meant by non-linear pharmacokinetics ?

(v) Define the terms clearance with formula.

PANKH-37 3 P.T.O.

PANKH-37
4

2. Solve any two : 20

(i)
5 5
Enlist and explain in detail mechanisms of drug absorption.
0
(ii)
2 0
Write a detailed4note on in-vitro-in-vivo correlation (IVIVC).

ANKH-37 (iii) Describe various pharmacokinetic models.

3. Solve any seven :


0 55 35

240
(i) Define the following terms :

(a)
5 5
Disposition
0
(b) 40
2 Perfusion rate
(c) Distribution

(d) Teratogenicity

0 55
(e) Blood brain barrier.
2 40
(ii) Explain in detail factors affecting renal excretion.

(iii) Explain in detail the methods for measurement of bioavailability.

(iv) Write down in detail bioequivalence study design.

(v) 5 5
Add a note on Michaelis-Menten equation.

(vi) 24 00
Explain any five non-renal routes for excretion.

(vii)
0 5 5 What is protein binding of drugs and its types and add a note on

4 0
2 (viii)
mechanism of protein drug binding.
5 5
5 4 0 0 of drugs.
Explain the various factors affecting distribution
0 0 5 2
24 (ix) Write a note on theories of drug dissolution.

PANKH-37 4

PANKH-37
4

Seat Number PANKH-40

0 55
BP-605T

2 4 0
Pharmaceutical Biotechnology
(736605)
ANKH-40
Total Pages : 5]
Time : 3 Hours Max Marks : 75

Note : (1) 0 55
Do not write anything on question paper except Seat No.
(2) 2 40
Draw well labelled diagram wherever necessary

0 5 5
40
(3) No supplement will be provided.

1. 2
Answer the following questions : 20

(i) The principal antibodies involved in Type II reaction are..........

(a) IgE and IgA


5 5
(b)
IgM and IgA
0(d) IgD and IgA
(c) IgG and IgM
2 40
(ii) Type I hypersensitivity includes all of the following except :

(a) Anaphylaxis

(b) Hay fever

(c) 5 5
Extrinsic asthma

(d) 24 00
Autoimmune hemolytic anaemia

(iii) The process of weakning a pathogen is called............

0 5 5(a) Vaccination (b) Attenuation


240 5 (c) Immunization 0 5 5
0 reduction
0 5 2 4
(d) Virulence

0
24 (iv) BCG vaccine contains...............
(a) Attenuated M. tuberculosis (b) Killed M. tuberculosis

(c) Killed M. bovis (d) Attenuated M. bovis

P.T.O.

PANKH-40
4

(v) The chemical used for conversion of toxin into toxoid is............

(a) Ethanol
0 55 (b) Chloroform

(c) 240
Formaldehyde (d) Hydrochloric acid

ANKH-40 (vi) Typhus vaccine is prepared by :

(a) Synthetic medium (b)


0 55
Lung tissue of Gerbis

(c) Fertile egg 2 40


(d) Brain of monkey

0 5 5
(vii)
2 4 0
How many histone molecules are found in nature ?

(a) 3 (b) 4

(c) 5 (d) 6
5 5
0 and winding of chromosomal
(viii) Proteins responsible for compact 0
packing
2 4
DNA are :

(a) Histones (b) Non-histone

(c) Trypsin (d) Serein

5 5
(ix)
00
V-shaped chromosomes are named as............
2 4
(a) Telocentric (b) Submetacentric

0 5 5(c) Metacentric (d) Acrocentric

240(x)5 The process in which bacteria can exchange 0plasmids


55
0 with other bacteria
0 5 is called : 2 4
240
(a) Binary Fission (b) Budding

(c) HGT (d) Fragmentation

PANKH-40 2

PANKH-40
4

(xi) The transfer of naked DNA from one cell to another is

transferred as :
0 55
(a) 2 40
Transduction (b) Lysogeny

ANKH-40 (c) Transformation (d) Conjugation

(xii) Specialized transduction is mediated by..............


0 55
(a) Lytic phages 2 40
(b) 0 5 5
Lysogenic phages
2
(c)
40Both Lytic and Lysogenic phages

(d) T4 phages

0 55
(xiii) Which of the following role is preferred by a bacteriophage in

transduction ? 2 40
(a) Vector (b) Donor

(c) Recipient (d) Episome

(xiv)
5 5
Transposons are................

(a) 24 00
RNA Sequences

(b) DNA Sequences


05 5
240 5 5
(c) Only found in eukaryotes
0 0 5
0 5 (d) Contain no genes
2 4
0
24 (xv) Conversion of cortisol to produce prednisolone is an example of ............

(a) Epoxidation (b) Deamination

(c) Dehydrogenation (d) Reduction


PANKH-40 3 P.T.O.

PANKH-40
4

(xvi) The non-steroidal substance used in the formulation of lotion and


cosmestics is :
0 55
(a)
2 40
Dihydroxyacetone (b) L-Ascorbic acid

(c) Prostaglandin (d) Cortisone


ANKH-40 (xvii) Which is the first steroidal compounds produced by microbial
transformation by corynebacterium sp. ?
0 55
(a) Testosterone (b) 2 40
Estrogen

(c) 0 5 5
Progesterone (d) Cortisone

2 40
(xviii) What is the detection of auxotrophs ?

(a) Spread Plating (b) Replica plating

(c) Streaking
5 5
(d) Pouring
0.................. .
(xix) 4 0
Somatic mutations are also called
2
(a) Spontaneous mutations (b) Bud Mutation/Bud Spots

(c) Induced mutations (d) None of these

(xx) Which of the following is not a product of fermentation ?

(a) Lactose 5 5 (b) Oxygen

(c) 24 00
Carbon dioxide (d) Ethanol

2. Solve any two : 20

4 0 055
(i) Define Protein Engineering. Explain different methods of Protein
5
2 5 engineering. 0 0 5
0 5(ii) 2 4
240 What are the different classes and functions of interferons ? Write the
different methods of interferon production.

(iii) Define hypersensitivity. Explain different classes of hypersensitivity


reactions.
PANKH-40 4

PANKH-40
4

3. Attempt any seven from the following questions : 35

(i) 55
What are different methods of attenuation ?
0
(ii) 2 40
What do you mean by immune suppression ? List out the drugs used

ANKH-40 as immune suppressant.

(iii)
55
Write different classes of antibodies and their functions.
0
(iv) 2 40
Briefly discuss steps involved in polymerase chain reaction.

(v) 0 5 5
Define Vector. Write the properties and examples of some artificial vectors
2 40
used in rDNA technology.

(vi) List out the various blood components and their use.

(vii) 55
What are the ideal characteristics of fermenter ? Mention the different
0
4 0
2 with their uses.
provisions provided in a fermenter

(viii) What are the effects of Mutations ?

(ix) Write the different methods of classification of Plasmids.

5 5
24 00

0 5 5
240 5 0 0 55
0 5 2 4
240

PANKH-40 5 P.T.O.

PANKH-40
4

Seat Number PANKH-45

0 55
BP-606T

2 4 0
Pharmaceutical Quality Assurance
(736606)
ANKH-45
Total Pages : 2]
Time : 3 Hours Max Marks : 75

0 55
40
Note : (1) Do not write anything on question paper except Seat No.
(2) 2
Draw well labelled diagram wherever necessary.

0 5 5
40
(3) All questions are compulsory.
(4) 2Figures to the right indicate full marks.
1. Solve all the questions : 20

(i) 5
Give benefits of ISO certification for pharmaceutical industry.
5
0Control Unit.
(ii) 40
Give any two functions of Quality
2
(iii) Classify glass container used in Pharmaceutical industry.

(iv) What are BMR and MFR ?

(v) Define calibration. Give its objectives.

5 5
00
(vi) Enlist different types of validation.

(vii) 24
Enlist steps in receiving of materials in warehouse.

(viii) Give different types of waste.


0 5 5
40(ix) Give importance of sanitation in sterile area. 5
2 (x)5 Enlist types of training given to personnel0in05a pharmaceutical unit.
0 5 2 4
242.0 Solve any two of the following : 20

(i) Explain in brief good laboratory practices.

(ii) Define ‘Quality by Design’ and explain its elements and tools.

P.T.O.

PANKH-45
4

(iii) Define validation, give its objectives and explain Analytical method
validation.
0 5 5
3.
2 0
Solve any seven of the4following : 35

(i) Define TQM and give its advantages.


ANKH-45 (ii) Write a note on NABL Accreditation.

(iii) Explain steps in complaint handling. 0 55


(iv) Define CGMP and give its objectives. 2 40
0 5 5
(v)
40
Describe the procedures followed for sampling and testing of raw
2
materials.

(vi) Write a note on ICH guidelines for stability testing of pharmaceutical


products.
55
0 9000 certification.
(vii)
2 0
Explain important elements of4ISO

(viii) Define aid locks. Explain its types and how they work.

(ix) Define the terms QA and QC and explain the differences between them.

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24 00

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PANKH-45 2

PANKH-45

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