SCHEME OF INSTRUCTION, EXAMINATION AND …gprcp.ac.in/syllabusmp/Pharm AQA Scheme - CBCS.pdf ·...

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G.Pulla Reddy College of Pharmacy

Hyderabad

Osmania University

1Chairperson, BoS Head of the Department Dean of the Faculty

SEMESTER - II

SEMESTER – III

SCHEME OF INSTRUCTION, EXAMINATION AND EVALUATION Program Code: 885 M. Pharm. (Pharmaceutical Analysis & Quality Assurance)

2015 – 16

SEMESTER - I

Course Code Course Title Hours/Week Credits Marks Durationof Exam L T P Internal End Exam

PY.09.884.11.T Pharmaceutical Analytical Techniques 3 0 - 3 25 75 3 PY.09.886.12.T Pharmaceutical Product Development 4 0 - 4 25 75 3 PY.09.885.13.T Quality Controlof Health Related Products 4 0 0 4 25 75 3 PY.09.885.14.T Instrumental Methods of Analysis 4 0 0 4 25 75 3 PY.09.885.15.T Quality Assurance 3 0 0 3 25 75 3 PY.09.884.11.P Pharmaceutical Analytical Techniques - 0 4 2 25 75 6 PY.09.886.12.P Pharmaceutical Product Development - 0 4 2 25 75 6 22 175 525 PY.09.885.10.S SAIL 1 2 0 2 Grade PY.09.885.11.S Seminar 1 0 2 2 Grade

Course Code Course Title Hours/Week Credits Marks Durationof Exam L T P Internal End Exam

PY.09.885.21.T IPR & Regulatory Affairs 3 0 - 3 25 75 3 PY.09.885.22.T Analytical Method Validation 4 0 - 4 25 75 3 PY.09.885.23.T Quality Control Methods 4 0 0 4 25 75 3 PY.09.885.24.T Biological Standardization 4 0 0 4 25 75 3 PY.09.88X.25.T Elective * 3 0 0 3 25 75 3 PY.09.885.22.P Analytical Method Validation - 0 4 2 25 75 6 PY.09.885.23.P Quality Control Methods - 0 4 2 25 75 6 22 175 525 PY.09.885.20.S SAIL 1 2 0 2 Grade PY.09.885.21.S Seminar 1 0 2 2 Grade * Discipline Centric –Pharmaceutical Packaging Technology / Drug Polymer Technology; Open – Quality Assurance & Management.

Course Code Course Title Hours /Week Credits Marks Duration in Weeks Internal External

PY.10.885.31.P Design Seminar 30 6 50 - 6 PY.10.885.32.P Report on Progressive Seminar 30 10 50 - 10

480 16 100

SEMESTER – IV

Course Code Course Title Hours /Week Credits Marks Durationin Weeks Internal External

PY.10.885.41.P Pre-Submission Seminar 30 10 50 10 PY.10.885.42.T Submission and Adjudication 30 12 200 6 PY.10.885.43.T Final Viva-voce 30 2 50 1

510 24 300 17

CONTROLLED DOCUMENTGPRCP-EXT/MPS/12-13/PA-QA/01

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2

P

Scheme of Total DuratiHours/WeekCredits Instruction MCourse Cod

Course ObjTo familiarize To understandlaboratory. To give traininTo build on th

Course OuBy pursuing th

- Rese- Food- Clinic

Unit - I :UV-Visible Sp(electronic traInstrumentatioillustrating themulticomponehydrocarbonsInfra-Red SpInstrumentatiohandling for IR

Unit - II :Nuclear Magspin couplingphenomena inSpectroscopyMass Spectroand its characRearrangemeand molecula

Unit - III :ChromatograChromatograpGas ChromatPharmaceuticLiquid ChromColumn SelecChiral Chroma

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Chairperson

PHARMA

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BoS

ACEUTICA

60 Hrs. 3 Hrs. 3 Lecture PY.09.884.1

nventional andmental concepts

e technique anded at UG level

ents are prepaelopment rma Industries and Quality Con

Basic principlecept of chroms and their sig

on and its utilWoodward-Fiend derivative spnteraction of in IR spectropy. Interpretation

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e of ExaminMarks :

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with matter andugation, solvenompounds and dies of drugsaximum for u

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and CI), Masrocesses and on to characte

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nation 100 20 05 75 3 Hrs.

pharmacy. lity control

d its effects nt and pH. complexes s including unsaturated

on bonds. s. Sample ectance).

ncept, spin- multiplicity

on-13 NMR

ss spectrum Mc-Lafferty ristic peaks

Thin Layer chanism .

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g Materials, al Analysis.


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Unit

ElectElectElectRadiELISA

UnitX- RacrystaTherBoo

1

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8

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t - IV : trophoresis: trophoresis (Ztrophoresis. SDio Immuno AsA - Instrument

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. Silverstein& Sons (A

. William Ke

. Jag MohaLtd., New

. Connors K

. Willard HH& Distribut

. Pavia DL, publishers

. Sharma B2006.

. Beckett, Adistributors

0. Ewing, GW1. Schirmer,

2000.

Principles, InsE), Isoelectric DS Gel Electrossay (RIA) andtation, Principle

opy: Origin of Xsingle crystal dal Techniques:erences: A, Holler, FJ, CHaryana, 2007. , RM, Webster

Asia) Pvt. Ltd., Semp. Organic s

an, Organic spe Delhi, 2005. KA. A Text booH, Merritt LL, Detors, New Delh Lampman GM

s, California, 20K. Instrumenta

AH, Stenlake, Js, New Delhi, 2

W. Instrumenta RE. Modem m

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Crouch, SR. P r, FX. SpectromSingapore, 200spectroscopy,

ectroscopy: Prin

ok of pharmaceean JA, Settle

hi, 1986. M, Kriz GS, Vy008. al methods of

B. Practical ph2004. l methods of c

methods of pha

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and ApplicatioEF), ContinuouBlotting T echnGeneral Princion for Analysis

aspects ofcrystder diffraction,

heoryand Appli

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metric identifica05. 3rd ed., Palgrav

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chemical anal

harmaceutical c

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ons of Moving us Electrophoniques. ples, Scope of

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lysis, 25th Ed.,

chemistry, Part

sis, 5th ed., Mcnalysis, Vol. I &

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2006. ed., Narosa pu

Wiley & Sons, analysis, 7th ed

pectroscopy. 4t

Goel Publish

I & II, 4th ed.,

Graw Hill, New& II, 2nd ed., C

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Osmania Univ

lectrophoresis ative) and Ca

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Baba Barkha N

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Osmania Univ


Course Obj

This subject imThe student lsubstances an

Course Ou

The students aphysical and pThey shall becdevelop the oUnit - I : Prand hygrosco

Design o f Materials and

Unit - II : Fcoloring and diluents and

Pre-formulaticompressible properties, co

Unit - III :Solubility: Imsolubility, phasDissolution: Factors influetesting for comedia, in-vitro

Unit - IV :Chemical StaStability TestinProduct Stabinfluencing-meTablets). Solid

Chairperson

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PHARMA


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after undergoinpharmaceuticacome aware of

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BoS

ACEUTIC


theoretical knoarious physicao be studied an

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mulation develoaceutical paramn the pharmace

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opmentofdosameter/propertieseutical product

in understandinal and excipientmber of experim

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n testing modetiontestapparatling and corre

cs, Factors Affe

of drugs ands, interpretatiools and Reports

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e of ExaminMarks :

mester ::

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age forms and is of raw matet development.

ng the influencets. ments to be co

nt, pharmaceuation.

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pharmaceuticn of kinetic das;

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nation 100 20 05 75 3 Hrs.

its stability.erials, drug

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utical salts

mization of

eservatives, ent bases,

nts, directly pients, flow

on, intrinsic

d non-sink. dissolution

Bio-relevant

cal Stability,

cals, factors ata (API &


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Hyderabad

Chairp

UnitGeneAct, DeveNoveNano

Boo1.

2. 3.

4.

5. 6. 7.

8.

9. 1011

12

131415

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t - V : eric Drug ProBolar Amend

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oks and RefeLachman L, Publishers, MSinko PJ. MaLieberman HPublishers &Conners KA.PhysicochemYalkowsky SDressman JSethi PD. QuDelhi, 2008. Carstensen JNew Delhi, 2Yoshioka S,

. Banker GS, R

. W. Grimm - Pvt. Ltd., Ba

. Beckett AH, Distributors,

. Indian Pharm

. British Pharm

. United State

ducts: Generadment, Principeric Drug Products: Nano-Phams;

erences: LiebermanHA,Mumbai 1991.artin's Physical HA, Lachman L& Distributors, N. A Textbook mical PropertieH. Techniques, Kramer J. Phuantitative Anal JT, Rhodes CT2005. Stella VJ. StabRhodes CT. M Stability testingngalore, 1999.Stenlake JB. New Delhi, 20

macopoeia. Comacopoeia. Brs Pharmacopo

Head of th

al Principles, Caples of Excluduct Approval. armaceuticals -

Kanig JL. The Pharmacy& P, SchwartzJB.

New Delhi, 200 of Pharmaceu

es of Drug Subs of Solubilizat

harmaceutical dysis of Drugs in

T. Drug Stability

bility of Drugs aModern Pharmag of drug prod Practical Phar04.

ontroller of Pubitish Pharmaco

oeia. United Sta

he Departme

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- Generation a

e Theoryand P

harmaceutical Pharmaceutic

05. utical Analysis stances. Ellis Hion of Drugs. V

dissolution testn Pharmaceuti

yPrinciples and

and Dosage Foaceutics, 4th Edducts. Mazzo D

maceutical Che

blication. Delhi,opoeia Commiates Pharmaco

nt

UT of Patent PRegulations –

nd Significance

ractice of Indus

Sciences, 5th Eal Dosage Form

Wells JI. PhaHarwood Ltd., Vol-12. Marcel ing. Saurabh Pical Formulation

Practices, 3rd E

orms, Springer (d., Marcel Dek

DJ. Internationa

emistry, Part I

, 1996. ission Office, Lopeial Conven

Dean of th

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Pharmaceutica– ANDA, Gen

e of Nano-susp

strial Pharmacy

Ed., B.I. Pub. Pvms: Tablets Vo

armaceutical P England, 1998Dekker Inc. Ne

Printer Pvt. Ltd.ns, 3rd Ed. CBS

Ed. CBS Publis

(India) Pvt. Ltdker Inc, New Y

al Stability Test

& II., 4th Ed.

London,2008. tion, Inc, USA,

e Faculty

Osmania Univ

als, Hatch - Waeric Drug Pr

pensions, Nano

y, 3rd Ed., Vargh

vt. Ltd, Noida, 2ol. I-II, 2nd Ed., C

re-formulation: 8. ew York, 1981., New Delhi, 2

S Publications,

shers & Distribu

., New Delhi, 2York, 2005. ting. Eastern P

CBS Publishe

2003.

5

versity

axman roduct

o-gels,

hese

2006. CBS

The

. 005. New

tors,

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ress

ers &


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Osmania Univ

QUA


Course ObjThis subject isproducts, Bioloquality controlfor analysis of

Course OuAfter the studeof pharmaceut

Unit - I :Quality ContCreams, Powdeye care prod

Unit - II :Quality Contvalue and expesticide resid

Unit - III :Quality Cont

1. V2. E3. A4.

Unit - IV :Quality ContSupplements.

Unit - V Quality ContDeterminationMilk Products

Books and 1. Commerc

2004.

Chairperson

versity

ALITY CO


: Mode :

de :

jectives: s aimed at giviogical productsl of prepared ff health related

tcomes: ents have undetical analysis fo

: trol of Cosmeders and Shamducts (eye shad

: trolof Herbal Pxtractive matterdues and MO’s

: trol of Biolog

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: trol of Nutrac

: trol of Food n of Moisture, A (Milk Powder,

Referencescial’s Manual on

BoS

ONTROL


ing knowledge s, food constitufinished produc

d products.

ergone the couor quality contr

ceuticals: Haimpoos), Persondows, eye liner

Products: Quar, foreign matts, UV and fluor

ical Products

htheria, Tetanueptokinase, Urohtheria, T etanhronic Gonado

euticals: Vitam

ConstituentsAsh, Nitrogen a, Margarine, Te

s: n Drugs & Cos

Head of th

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13.T

about differentuents and Nutracts. Students k

urse work, they rol of various p

r care productsnal HygienePros, and eye brow

alitycontrol of cer, bitter valuerescence analy

s: Biological as

us, Rabies. okinase. us.

otropin, Oxytoc

mins (A, B1, B

: Carbohydrateand Physical Cea and Coffee

smetics. 2nd Ed.

he Departme

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t quality controaceuticals. Thisknow about pr

y shall become roducts as men

s (shampoo anoducts (shavingw pencils)

crude drugs (We, haemolytic ysis of powdere

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th application oabove units.

baby care prodshave lotions a

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cro Nutrients a

Special Emphacal Methods fo

s (India) Pvt. Lt

he Faculty

TS

nation 100 20 05 75 3 Hrs.

tics, Herbal evaluation/ elines used

ofprinciples

ducts (Oils, and soaps),

ation of Ash ming index, cal tests.

and Health

asis in the or Milk and

td., Delhi,


Library


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Chairp

2. SL

3. K4. N5. M

H6. E7. L

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Sharma PP. CoLtd., Delhi, 200Kokare CR. PhNanda S, NandMukherjee PK.Horizons, New Evans WC. TreLachman L, LiePublishers, BoRemington: Th2006. Agrawal SS, PaNelson DL, CoxMurray RK, Gra2006. David PearsonNielsen S. Intro

osmetics-Form05. harmaceutical da A, Khar RK.. Quality Cont Delhi, 2007. ease and Evaneberman HA, Kmbay, 1991. e Scienceand

aridhavi M. Hex MM. Lehninganner DK, Rod

. The Chemicaoduction to the

Head of th

ulation, Manufa

Microbiology a. Cosmetic Tecrol of Herbal

ns PharmacognKanig JL. The T

Practiceof Pha

rbal Drug T ecger Principles owell VW. Harp

al Analysis of Fe Chemical Ana

he Departme

acturing andQu

and Biotechnolchnology. BirlaDrugs: An Ap

nosy. 15th ed., Theoryand Pra

armacy. 21st Ed

hnology. Univeof Biochemistryer’s Illustrated

Foods, 7th Ed., alysis of Foods

nt

ualityControl. 3

ogy. 2nd Ed., Na Publications Ppproach to Ev

Saunders, Chiactice of Indus

., Vol. I & II, Lip

ersities Press (Iy. 4th Ed., ReplBiochemistry, 2

Churchill Livins. Jones & Bart

Dean of th

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3rd Ed., Vandan

Nirali PrakashaPvt. Ltd., Delhi,aluation of Bo

na, 2004. strial Pharmacy

ppincott William

India) Pvt. Ltd.,lika Press Pvt. 27th Ed., McGr

ngstone, Edinbutlett Publishers

e Faculty

Osmania Univ

na Publications

n, Pune, 2006 2007.

otanicals. Busin

y, 3rd Ed., Vargh

ms & Wilkins, No

Hyderabad, 20Ltd., India, 200

raw-Hill, New D

urgh, 1976. , Boston, 1974

7

versity

s Pvt.

.

ness

hese

oida,

007. 06.

Delhi,


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Osmania Univ


Course ObjThis subject iprinciples and

- To gi- To gi

Course OuAfter the studinterpretativein understand

Unit - I :Microscopy: Atomic Force Optical RotatInstrumentatio

Unit - II :PotentiometryCell Potential,ConductometConductance,

Unit - III :SpectrophotoSpectroscopy Spectro-fluorLuminiscence

Unit - IV :Hyphenated LC-NMR in PParticles SizeSpectroscopy

Unit - V PharmacopoeTests; MiscellSample PrepExtracts, Cell

Chairperson

versity

INSR


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oks and RefeSkoog DA, HolHaryana, 2007Silverstein RMSons (Asia) PvWillard HR, Medistributors, NeEwing GW. InsSchirmer RE. MLee DC, WebbGurdeep R. ChAshutoshkar, P

Whoston C. X-

erences: ller FJ, Crouch. , Webstar FX.

vt, Ltd., Singapoerritt LL, Dean ew Delhi, 1986strumental MethModem Methob M. Pharmacehatwal, InstrumPharmaceutical

ray Methods, J

Head of th

SR. Principles

Spectrometricore, 2005. JA, Settle FA. . hods of Chemi

ods of Pharmaceutical Analysis

mental Methodsl Drug Analysis

John Wiley & S

he Departme

s of Instrument

c Identification

Instrumental M

ical Analysis, 5ceutical Analyss, Blackwell pus of Chemical As, New Age Inte

ons, New York

nt

al Analysis. 6th

of Organic Co

Methods of Ana

5th ed., McGrawsis, Vol. I & II, 2blishing, AustraAnalysis, Himaernational Pub

k, 1987

Dean of th

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Ed., Baba Ba

ompounds. 6th

alysis, 7th Ed.,

w Hill Book Cond Ed., CRC Pralia, 2004.

alaya Publishinblishers New D

e Faculty

Osmania Univ

rkha Nath prin

Ed., John Wile

CBS Publishe

mpany, NY, 19ress, Florida, 2

g House, 2006Delhi.

9

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ters,

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rs &

985. 000.

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10


Course ObjAchieve comstandards syDevelop and i

Course OuThis subject is

- Acquirerelated

- Addresscontinu

- UndersPharma

Unit - I :Basic Qualityof variation, qreceipt, testintemperature, pfacilities (desimaintenance)

Unit - II :In-Process Qthickness, friafeel, volume parenterals (pencountered a

Unit - III :Quality SysteGuidelines anAudits: GMPAudits, ExternUnit - IV :Quality Contof Key PersoWorksheet, TeDocumentatio(CAPA), Out o

versity

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nation 100 20 05 75 3 Hrs.

bal quality

lence

guidelines

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cedures in

ns, sources ecifications,

ess control, buildings & sanitation &

hardness, arance and ormity) and ). Problems

Standards,

cond Party

ponsibilities , Analytical

tive Action


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UnitImpuImpuper IC

StudCom

Boo1. G2. S3. S4. Q

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12

P


Course ObjTo make studinstruments in

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PHARMA


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BoS

ACEUTICA

60 Hrs. 4 Hrs. 2 Practical PY.09.884.

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IQUES

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experiments).

at least 5 comp

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nation 100 20 05 75 6 Hrs.

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Head of th

EUTICAL

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the solubility of bility of drugs. transdermal drug in three diffn and hydrotropcompounds uson and solid doide, hydrochlor

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14

INTELLE


Course ObjTo make stude

Course OuOn completionRegulatory AffFurther to famSustainable D

Unit - I :Intellectual Ppatentable, Igeographical India Patentsmaintaining th

Unit - II :International specification &International Historical perswithdrawal ofmprograms, Parfeatures, spec

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ations and

nventions – ns, types,

ost Grant),

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1 (Quality

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UnitInduMechFire PolluEnvirOtheSust

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t - V strial Safety hanical, Electricand Explosionution Control ronmental Polluer Product Retainable Deve

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Course ObjDevelop and vUnderstand th

Course OuTo equip stud

Unit - I :Analytical VRetrospective

Unit - II :Analytical PrRuggedness, their Correct Assays.

Unit - III :DevelopmentValidation of vSpectrophotom

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Utilities ValidSystems – DCleaning ValAcceptable Lim

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ANA


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References, Wachter AH. FJ, Apalloco J

. Pharmaceutic Alasante KM.Publications, N

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ALYTICA

60 Hrs. 4 Hrs. 4 Practical PY.09.885.2

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troduction; Hisncurrent Valida

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lidation, 3rd ed.,tical Processes

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f Validation; Master Plan a

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f Biological samfecting Extractind Cross-Valida

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, CBS Publicats-Sterile Produ

Noida, 2006. tion of Impurit

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N

e of ExaminMarks :

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techniques.

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Robustness, of Significant Fion Different C

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Pharmaceuticion Validationrotocol; Determrical Calculation

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Validation, Protocol.

Specificity, Figures and Category of

nance and meter, FT-IR

n of Drugs

cal Water ;

mination of n of Limits.

hi, 2005. ekker, NY,

aceuticals.


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Chairp

5. P6. S7. M8. M9. S

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person BoS

Parker M. QuaShah DH. SOPMehra ML. GoMaitra K, GhosSnyder, KirklanYork.

lity Assurance P Guidelines. Bood Manufactursh SK. A Guidend & Glajch, Pr

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and TQM for Business Horizoring Practices

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O

Dean of th

Royal Society

ncy.

1997, Wiley In

Osmania Univ

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nterscience, Ne

versity

17

Pub.

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Library


Hyderabad

O

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18


Course ObjTo equip studindustry. Course OuAt the end ofto enhance Unit - I :Qualitative Ain the use of t

abcdefgh

Unit - II :Quantitative Determination

A) Hydroxy

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: rolof Excipien preservatives

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BoS

QUALITY

60 Hrs. 4 Hrs. 2 Practical PY.09.885.2

fessionally com

the student ivalue of the

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phenyl tetrazolio quininone -4

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nation 100 20 05 75 6 Hrs.

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rs, viscosity H, moisture on ignition,

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UnitQualcontaphysnon meta

Boo1.

2.

3.

4.

5.

6.

7. 8. 9.

person BoS

t - V : lity Control ofainers, powdeicochemical testerile solids a

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f Packaging Mered glass tesests – plastics,and liquid dosaand rubber clos

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Sheskey PJ, On, 2006. LiebermanHA,Mumbai 1987. uantitative AnaNew Delhi, 20Stenlake JB. New Delhi, 20The Science a2005. macopoeia. Comacopoeia. Bries Pharmacopo

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Materials: Contst, water atta polyethylene c

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& II, Lippincatt

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Osmania Univ

e Faculty

al resistance – nd other poly dose containeainers – perme

CBS Publishe

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CBS Publishe

Williams & Wil

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glass ymers: ers for eation,

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Library


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20


Course ObjTo train studeTo impart knoTo give them

Course OuAt the end of tpre-clinical ev

Unit - I 1. Heparin, InsUnit - II 1. Living contaUnit - III 1. Vitamins - CUnit - IV Overview, typeprimary bioasofvariation; PrRabies VaccinProduction, Ch

Unit - V Detailed StudAssay of GasAlbumin, HumBiotechnology

Books and 1. Indian Ph2. Bochmma3. DC Garro4. RV Smith5. Pulok K M6. British Ph7. Classifica

versity

Chairperson


: Mode :

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: Detailed Ssulin, Posterior: Principles

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: Bioassay y of Principles

s-Gangrene Anman Plasma y Products (ery

Referencesarmacopoeia 2an & Hassan, Pott, Quantitativeh, JT Stewart, TMukherjee: Quaharmacopoeia, ation of Cosmet

BoS

Biolo

60 Hrs. 4 Hrs. 4 Lecture PY.09.885.

ous biological eofficial / non-ofrying out some

student acquir related areas.

Study of Prir Pituitary; 2. D and Proce

ccines, 2. Endological Assamine; 2. Antibiol Assay anddirect and assag, statistical pcacyor Antimi

us Antitoxin; erties and Test

of Biologics s and Proceduntitoxin, Blood Protein fractio

ythropoietin, int

s: 2007, ControllePharmaceuticale Analysis of DrTextbook of BioalityControl of H Departmentof tic Raw Materia

Head of th

ogical Stan

.24.T

evaluation methfficial methods of these techn

re the wide exp

inciples andDiphtheria, Typhdures involvotoxins, 3. Histaay tics such as Ne Pyrogen A

ay based on quprinciples in bcrobial Effectiv

ts of Bacterial P

ures involved inand Blood re

on, Human Bterferons, strep

er of Publicationl Analysis, editerugs. CBS Pub

opharmaceuticaHerbal Drugs, Health, UK. als.

he Departme

ndardizati

hods & the sign of evaluation fniques in the la

posure to stude

d Procedureshoid ved in Bioloamine like subs

eomycin SulfateAssay uantal responsebioassay- randveness testing

Pyrogens and E

n Bioassay of lated Products

Blood Coagulatptokinase)

ns, Govtof Indied by Higuchi. blishers, New Dal Analysis. Business Horiz

nt

ion


nificance of sufor a wide rangboratory.

ents in the area

s Involved i

ogical Testsstances, 4. Tox

e; 3. Vaccine -

es, parallel linedomization, re as per USP;

Endotoxin;

Estrogens, Hes (Anti-Blood Gtion factors),

a, New Delhi.

Delhi.

zons Pharm. P

Dean of th

e of ExaminMarks :

mester ::

mester :Duration :

uch tests. ge of drug dosa

a of New Chem

in Bioassay

of the followxic elements.

Diphtheria

bioassays, beneplication and

Evaluation o

patitis VaccineGrouping Seruand Biologica

ublishers, New

he Faculty

nation 100 20 05 75 3 Hrs.

age forms.

mical Entity

y of

wing

nch top and elimination f Oxytocin,

e, Biological um, Human al Assay of

w Delhi.


Library


Hyderabad

Chairp

Sche

TotaHouCredInstrCouCouTo deTo un

CouTo ap

UnitPharand otempProdFlexCorrCaps

UnitGlasPlastchemparenPapeMeta& Lin

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urse Outcomppreciate the im

t - I : rmaceutical Paouter package

perature, hazardduct-Package ible Packagin

rugated and Ss and Closure

t - II : ss Containers tics Containe

mical, mechaninterals and traer and Paper Bal containers: ning.

t - III : ile product pa for sterile proe products. Stemerits of variouronmental Conational regula

t - IV : kaging Maching machines, caances in Pack

kaging, aerosol

ARMACE


de : Lectu: PY.0

ives: tanding and pro types of pack

mes: mportance of P

ackaging: Pures used for diffds encountere Compatibilityg: Types of fil

Solid fiber Boes: Types; caps

for Pharmaceers for Pharmcal and biolonsfusion sterile

Board: Types o Aluminum & T

ackaging: Genoducts includingerile product filus packages. Eonsiderations:ations

nery: Introductapping machinkaging Techno packaging, et

Head of th

E

UTICAL

Hrs.rs.

ure09.885.25.T

ovide scientific kaging and impr

Pharmaceutical

rpose of packaferent pharmacd by the packay: Stability of pms, co-extrude

oards and Boxs, closures, line

euticals: Glassmaceuticals: C

gical propertiee drip kits. Quaofpaper, foldingin Plate Drums

neral principlesg small volumeling andsealing

Evaluation of th: Packaging an

ion, strip packanes, machineryology: Blister tc.

he Departme

ELECTIVE

PACKAG

basics of the prove the standa

l Packaging Te

aging, prerequisceutical dosageage during storproduct, packaged films, foils, cxes: Type of cers, child resist

types, their chClassification oes; Additives aality control tesg cartons, quals, Collapsible T

s of packaging e and large volug machinery i.e

he sterile prodund recycling of

aging machinery employed for packaging, tam

nt

E

GING TEC

packaging techards of packag

echnology

sites of an idee forms, selectrage and distriging selection coating and lamcorrugation mettant caps. elast

hemical performof plastics, plaand fabrication ting and biologity control testin

Tubes & Aeroso

of sterile produme parenterae. ampoule fillinuct packages. f packaging m

ry, form, fill and liquid formulat

mper evident pa

Dean of th

O

CHNOLO

Scheme of EMax. MarksMid SemestQuizEnd SemestExam Durat

hnology ging technology

al package, vaion of a suitabbution. and developmminates, shrinkthods. tomeric closur

mance, testing aastic polymers processes. Pgical toxicity. ng of paper an

ol Containers, L

ducts. Various als. Types of clng andsealingm

materials along

d seal machinetion packagingackaging syste

e Faculty

Osmania Univ

OGY


: 0er : 7tion : 3

y

arious types of ble package, st

ment criteria. k and stretch fi

res for parente

and quality con and their phy

Plastic contain

d paper boardLacquering, Coa

types of contaosures used fomachine. Limita

with national

es, liquid and sg. ems, child resis

21

versity

n 00200575

Hrs.

inner torage

ilms.

rals,

ntrol. ysico- er for

. ating

ainers or the ations

and

solid

stant


Library


Hyderabad

O

Osmania Univ

Unit - V

22

Labels and Llabel, bar codlegal requiremConcept of pa

Books and 1. Dean D.A., 2. Jain U.K., G3. Kirwan M.J4. Walter Soro5. Lockhart H.6. Hendrickso7. Herrick A.D8. Yam K.L. T9. Selke S.E.M10. Hanlon J.F

versity

:

Chairperson

Labeling: Objee label, radiofr

ments of labelinaperless labelin

References Evans E.R. HaGoupale D.C., N. Paper and Pa

oka. Fundamen., Paine F.A. Pan R. Remington. Drug Produc

The Wiley EncyM. UnderstandiF., Kelsey R.J.,

BoS

ectives and corequency(RF) lng, packaginginng and new de

s: all I.H. PharmaNayak S. Pharaper Board Pacntals of Packagackaging of Phn The Science

cts, Labeling, Pyclopedia of Pacing Plastic Pac, Forcinio H.E.

Head of th

ntents of a phlabel, structurenserts and outsevelopments in

aceutical Packarmaceutical Pacckaging Technging Technologharmaceuticals and Practice oackaging, Regckaging Technockaging Techno Handbook of P

he Departme

harmaceutical led program labeserts. Adhesiven labeling tech

aging Technologckaging Techn

nology. Blackwey. Institute of P

s & Healthcareof Pharmacy, Lulation. Generaology. John Wilology. Karl HanPackage Engin

nt

label. Types ofel, in-mouldlab

es and machinnologies.

gy. Taylor & Frology. Pharma

ell Publishing LtPackaging Prof Products. Blaippincott Williamal Books, LLC. ley & Sons.

nser Verlag. eering. Techno

Dean of th

f label (includibel and decorateryemployed f

rancis. Med Press. td. fessionals.

ackie Academicms & Wilkins, 2

omic Pub. Co.

he Faculty

ng bilingual tive labels), for labeling.

c & Prof. 21st Ed.


Library


Hyderabad

Chairp

ScheTota

HouCredInstrCouCouAcquto maAddreimpro

CouTo emana

UnitBasiof VaReceTemBuildSanit

UnitEquiQualStanDisinTotaMana

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Qeme of Instral Duration urs/Week dits ruction Modurse Code urse Objectiuire knowledgeanufacturing aess quality issuovement. Unde

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t - I : c Concepts oariation, Qualityeipt, Testing, Sperature, Pres

dings & Facilitietation & Mainte

t - II : ipment Qualiification (OQ) dard Operatin

nfection, Sterilizl Quality Management Tools

t - III : ntory ManageEOQ, Inventoragements Systerials Manageucts; Finished Culture Media

t - IV : man Resources

Personnel; Perlities Manageing; Air-Condittenance; Utiliti

QUALITY ruction

: 60 H: 3 H: 3

de : :

LecPY.

ives:

e on various qund distributionues and providerstand the imp

mes: to be profess

ut in the pharm

of Quality AssuyAssurance forampling and C

ssure & Humides (Designand enance) Equip

ification (EQand Performang Procedurezation, Membranagement (TQs, Tools and T

ement: Costs, ry Models, Saftems, Inventoryment: Introduc Products; Reje; Waste Mater

s Managemenrsonal hygiene ment: Introductioning; Sewages; Water; Pow

E

Head of th

ASSURA

Hrs.Hrs.

ture .09.885.25.T

uality assuranc.

de solutions neportance of eff

sionally knowlemaceutical indu

urance: Concr Raw Material

Certificate of Andity Control T Construction Fment’s (Const

Q): Design Qnce Qualificaties (SOP): Opeane Filtration eQM): PrinciplesTechniques of Q

Inventory Catefety Stock-Stocy Evaluation. ction; Purchasiectedand Recoials; Reference

nt: Introduction; and clothing; Lction; Principae, Refuge and

wer; Steam; Va

ELECTIVE

he Departme

ANCE AND

T

ce systems, pro

eded to attain fective manage

edgeable to sustry.

ceptof Quality Cs, APIs, Packnalysis), ProduTests, Tests fFeatures, Consruction, Cleani

ualification (Don (PQ) erations like Cetc. s, Elements ofQuality, New Q

egories, Selectick Out, Lead T

ng; Raw Materovered Materiae standards; M

; Qualification ELegal Aspects; l Area; Plumb

d Disposal of Wacuum; Air; Gas

E

nt

D MANASMMQEE

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Quality leadersement and doc

ustain global

Control & Quaing Materials &

uction (Changefor Air flow Pastruction Materng and Mainte

DQ); Installatio

Cleaning, Fillin

f TQM, ContinQuality Tools a

ve Inventory CTime–Reorder

rials; Packagingls; Recalled Pr

Miscellaneous M

Experience and Consultants

bing and DrainWater; Washinses; etc.,

O

Dean of th

AGEMENTScheme of EMax. Marks Mid SemesteQuizEnd SemesteExam Duratio

urrent regulator

ship in an envircumentation.

quality standa

lity Assurance,& Finished Prode Control, Asepattern, Microbiials, Lighting, Aenance, Calibra

on Qualificatio

g, Drying, Com

nuous Improvend T echnique

Control, Reorde Time Method

g Materials; Introducts; ReturnMaterials;

d Training; Res

nage system; Lng and Toilet F

Osmania Univ

e Faculty

T Examination

: 10er : 2

: 0er : on :

73

ry guidelines re

ronmentof con

ards and prod

, Functions, Soducts (Specificaptic Process Coological Monit

Air Handling Syation & Handli

on (IQ); Ope

mpression, Co

ement and Leaes

er Quantity Mes, Modem Inve

termediate andned goods; Rea

sponsibilities an

Lighting; VentilFacilities; Sanit

versity

23

n 00 200575

Hrs.

elated

tinual

uctive

ources ations, ontrol, toring) ystem, ng)

erating

oating,

arning,

ethods entory

d Bulk agents

nd

ation; tation;


Library


Hyderabad

O

Osmania Univ

Unit - V

24

Manufacturinand Cross CDeviations, DMaterials. DocumentatioProduction anformat; ProduMaterial recei

Books and 1. Gupta S2. Sharma 3. Sharma 4. Quality A

WHO, G5. Basic Te6. The Inte7. Mehra M8. Subrahm9. Quality A

10. Quality APharma

11. Regulato

abcde

12. Sidney H.

versity

:

Chairperson

ng OperationsContamination,

rug Product In

on and Recond ControlRecouct complaint dpt; Sampling;

ReferencesSC. Fundament PP. How to Pr PP. How to PrAssurance of P

Geneva, Pharmaests for Pharmernational PharML. Good manmanyam.CVS, PAssurance Man

Assurance andBook Syndica

ory Guidelines

a. Australian cob. 21 Code of c. MHRA, UK Gd. GMP Guidele. Schedule M

. Willing, GMP

BoS

and Control: Processing of

nspection, Exp

rds: Introductiord; Important Sdocument; InteDispensing &

s: tals of Statisticsractice GMPs, ractice GLP, VPharmaceuticaa book syndicaaceutical Subsrmacopoeia, Voufacturing pracPharmaceuticanual, DH Shah

d Quality Manate, Hyderabad

Related to GM

ode of GMPforFederal RegulaGuidelines on Glines byMedici of D & C Act

for Pharmace

Head of th

Cleaning Validf Intermediatespiration Dating,

ion; SpecificatSOPs and Recernal audit doStorage docum

s. 6th Ed., Hima 4th Ed., Vanda

Vandana Publicl (A Compendiate, Hyderabadstances, WHO,ol. I-II, 3rd ed., ctices (GMP),

al Productionan, Business hor

agement in Ph

MP by

r medicinal proation, parts 210GMP nes Control Co

th uticals, 5

Edi

he Departme

dation; Sanitatios and Bulk pr, Examination

tions; Master Pcord; ChangeCocument; Prodment;

alaya Publishinana Publicationcations Pvt. Ltdum of Guidelind, 2002. , Geneva, All In WHO, GenevaUniversity Boo

nd Managemenrizons, New De

harmaceutical

th oducts, 16

Aug

0, 211 & 58. (U

ouncil of South

ition, Marcel D

nt

on of Manufactroduct, Packag of Labels, Ca

Production andontrol; Site Ma

duct recall doc

ng House, Hyds Pvt. Ltd., Del., Delhi, 2000.

nes and Selecte

ndia traveler boa, 1981. k Agency.

nt, 2005, Vallabelhi.

Industry, Y. A

g. 2002. USFDA guidelin

Africa

Decker Series

Dean of th

turing Premisesging Operationartons and Oth

d Control Recaster File; Chancument; IPQC

derabad, 2004. hi, 2004.

ed M aterials) V

ook seller, India

bh Prakashan, N

Anjaneyulu, R.

nes)

he Faculty

s, Mix –ups s, Process her Printed

cord; Batch ngecontract document;

Vol. I & II,

a, 1990.

NewDelhi.

Marayya.


Library


Hyderabad

Chairp

Sche

TotaHouCredInstrCou

CouTo kn

CouTo ac

UnitGene(moleof popolymchara

UnitEvalcharapolye

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person BoS


urse Objectinow and under

urse Outcomcquaintwith the

t - I : eral Study of ecular mass, molymers, genemerizations witacteristics, cry

t - II : uation of Polacterization in electrolytes and

t - III : rapeutic Appegradable polegradable polyers (polymeric

t - IV : interactions o

apeutics, targetntion effect (EPune-modulator

t - V : ymer Drugs anapeutics

oks and RefeJ. Brandrup, E.L. H. Sperling, H. Morawetz, MC. Tanford, Ph

DRUruction

: 60 H: 3 H: 3

de : :

LecPY.

ives: rstand the impo

mes: e knowledge o

Polymer Scimolecular weigral methods oth examples.

ystallinity.

lymers in Sosolution (therm

d polyampholyt

lications of lymers, biodeymers in pare micelles, poly

of Polymers: Ited polymer th

PR), functional s, stimuli respo

nd Regulatory

erences: . H. Immergur; Introduction to

Macromoleculeysical Chemist

E

Head of th

UG POLY

Hrs.Hrs.

ture .09.885.25.T

ortance of polym

f significance o

ence: Classifihtdistribution, cof preparation Methods of p

olution: Polymmodynamics oftes, cross-linke

Polymers: Pegradability anenterals and symer-coated lip

Interactions of herapeutics, paexcipients andonsive systems

Issues: Prosp

Polymer Hando Polymer Sciees in Solution (try of Macromo

ELECTIVE

he Departme

YMER TE

T

ymers use in dru

of polymers in d

cation of polymconformation a of polymers olymer modific

ers in solutionf polymer soluted polymers an

Polymers for nd biodegradurgicals, polymposomes, nano

polymers with assive targetingd biologicalresps and intracellu

pects of Polyme

dbook ;John wilence, Wiley, NY(2nd ed. ), Wileolecules, John

E

nt

CHNOLO

ug developmen

drug developm

mers, Macromand configuratilike solution bcation, Solid s

ns: Solubility otions), Viscositnd polymer co

therapeutic aability testingmer-drug conjoparticles, mic

tissues and cg of polymeric ponsemodifiersular drug delive

er Drugs and R

ley and Sons Y, 1992. ey-Interscience Wiley, NY, 196

O

Dean of th

OGY Scheme of EMax. MarksMid SemestQuizEnd SemestExam Durat

nt

ment.

molecules: strucion), Major strabulk, suspensistate properties

of polymers, mty and viscoelamplexes.

applications, of polymerugates, self-as

crospheres, etc

cells, Pharmaco drugs, enhancs, polymeric imery.

Regulatory Cha

e, NY, 1975 61.

Osmania Univ

e Faculty


: 0er : tion :

73

cture and propategies for synon and emulss of polymers

methods of poasticity of poly

biocompatible s, applicationssembled polyc.)

okinetics of poced permeatio

mmune-adjuvant

allenges in Poly

versity

25

n 00200575

Hrs.

perties thesis sions, , flow

olymer ymers,

and ns of ymeric

olymer on and ts and

ymer


Library


Hyderabad

O

26

Osmania Univ

5. F. W. Billm6. B. D. Ratn

in Medici7. Biomedic8. G. Gebele

Press, Ne9. D. S. Soa10. J. R. Rob11. N. K. Jain12. P. J. Tarc13. A. F. Kyd

Inc. 14. Academic15. Self-Asse16. P. L. Felg

Chairperson

versity

meyer, Jr. Texner, A. S. Hoffmne, Academic al Polymers anein. T. C. Chin ew work. ane; Polymer Abinson and V. Hn; Controlled ancha; Polymers onieus; Contro

c/Plenum Publembling Complegner, L. W. Sey

BoS

xtbook of Polymman, F. J. SchoPress, San Die

nd Polymer Th and V. C. Yan

Applications for H. Lee: Controlnd Novel Drug for Controlled lled Release T

ishers, NY, 20exes for Gene

ymour, Eds. Joh

Head of th

mer Science, 3oen, J. E. Lemoego, 1996.

herapeutics, Edng; Cosmetic a

Biotechnologyled Drug Delive Delivery; CBSDrug Delivery; echnologies: M

01. Delivery. Fromhn Wiley & Son

he Departme

rd Ed. John Wilons, Biomateria

ds. E. Chiellini and Pharmaceu

y; Prentice Hallery – Fundame publications. CRC Press.

Methods, Theory

m Laboratory tons: New York, 1

nt

ley, New York, als Science. An

et. al. , Kluwerutical Applicatio

l Inc. entals and App

yand Applicatio

o Clinical Trial.1998.

Dean of th

1984. Introduction to

rCharles ons of Polymers

plication; Marce

on, Vol -I& II; C

. A. V. Kabanov

he Faculty

o Materials

s; Plenum

el Dekker.

CRC Press

v,


Library


Hyderabad

Chairp

Sche

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Analytical methsuitability, selecHPLC.(7Expts) a. Paracetamb. Diclofenacc. Cetrizine sd. Metronidae. Chloramphf. Ibuprofen g. ParacetamValidation of foa. Autoclave b. Hot air ovec. Powder Md. Tablet ComValidation of aValidation of aCleaning validIdentification oHCl.(3Expts) Stability indicaLimittest for hDetermination

oks and Refe

a R. Berry &nc. .J. Carleton econd Edition

M.A. Potdar, PM.A. Potdar, C

ANALY

ruction : 60 H: 4 H: 2

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ives: ic principles inv

mes: significance of

hod validation fctivity and robu

mol tablets c sodium gel. syrup. zole infusion. henicol capsuleand Paracetam

mol and Diclofeollowing equipm

en ixer (Dry) mpression Maca processing aat least two anadation ofone eqof impurities in

ating assays forheavy metals on of residual sol

erences:

& Robert Nash

and J.P. Agn Revised &PharmaceuticCurrent Good

Head of th

YTICAL M

Hrs.Hrs.

ctical.09.885.22.P

volved in the An

f Analytical Met

for the parameustness for the

es. mol tablets enac sodiumtament

chine rea alytical instrumquipment. drug substance

r Ranitidine HCf herbal prepalvents by GC. (

h, Pharmaceu

galloco, Valid Expanded, Mal Quality A

d Manufactur

he Departme

METHOD

P

nalytical Metho

thod Validation

eters accuracy, following drug

blets.

ments.

es byTLCand

Cl and Aspirin brations - Arsen(2Expts)

utical Proces

dation of PhMarcel Decke

Assurance, Niring Practice

nt

D VALIDA

SMMQEE

od Validation

precision, repegs/formulations

LC method - A

by LC method.(ic, lead, cadmi

s Validation,

harmaceuticaler Inc. irali Prakashas, Pharma-M

Dean of th

O

ATION

Scheme of EMax. Marks Mid SemesteQuizEnd SemesteExam Duratio

eatability, specif byUV-Visible

Aspirin, Paracet

(2Expts) iumand mercu

Second Edn

Process (St

an, Pune. Med Press, Hy

e Faculty

Osmania Univ

Examination: 10

er : 2: 0

er : 7on : 6

ficity, system Spectroscopya

tamoland Raniti

ry.(2Expts)

, Marcel Dek

terile Produc

yderabad.

27

versity

n 00200575

Hrs.

and

idine

kker

cts),


Library


Hyderabad

O

28

Osmania Univ


Course ObjTo learn and u

Course OuTo ensure the

List of Exp1. Qualitative

and reacta. Oxidativb. Condenc. p-Dimed. Folin Ce. Diazotizf. Oxidatio

2. Analysis o3. Quality Co4. Identificat

Paracetam5. Detection6. Effectiven7. Evaluation8. Determina9. Simultane

10. Expe

Books and

Chairperson

versity

Q


: Mode :

de :

jectives: understand the

tcomes: e quality of drug

periments: e and Quantitations. ve Coupling Rensation Reactio

ethyl Amino CinCiocatecu (FC) zation followedon followed by of Active Pharmontrol Tests of tion of Impuritiemol, Aspirin, Ib and Quantitati

ness of Anti-Micn of Congealination of Viscosieous Estimation

eriments based

References

BoS

QUALITY

60 Hrs. 4 Hrs. 2 Practical PY.09.885.

e conceptual an

gs and drug for

ative Analysis o

eaction using 3on using the Rennamaldehyde Reagent d by Coupling R Complexation maceutical Ingr Packaging Maes and related suprofen) ive Determinatcrobial Preserv

ng Temperatureity of Exceipienn of Drugs in fix

on Gel Doc Sy

s:

Head of th

Y CONTR

.23.P

nd experimenta

rmulations

of Some Pharm

3-Methyl – 2 – eagent (PDAC)

Reaction Reaction redients (API) aterials substances in A

ion of Antioxidavatives (Preserve, Gelling Temnts using Brookxed dose comb

ystem for Prote

he Departme

ROL MET

al basics of qua

maceutical Dosa

Benzothiazolino

API’s (Albenda

ants and Presevative Challengperature, and Sk-Field Viscombinations

ein based Drug

nt

THODS


ality control met

age Form using

one hydrazine

azole, Metronid

ervatives ge Test) Swelling Tempeeter

gs

Dean of th

e of ExaminMarks :

mester ::

mester :Duration :

thods

g the following

(MBTH)

azole, Diclofen

erature of Excip

he Faculty

nation 100 20 05 75 6 Hrs.

reagents

nac,

pients


Library


Hyderabad

Chairp

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t - II : FTING TITLES- Tables as

relationshi- Formatting- AppendiceWriting processcking: Organizaity and PrecisioTS OF DISSEduction, Reviewent, continuity,

ferences: APA (1984): PuCooper, H.M. (Dunn, F.V & O

SCIENT


de : Tuto: PY.0

ives: eciate and undlop competenceeither a draft r

mes: documentwith s

ND EVALUATItion under fact/t forms. EANS OF COM notes and reputlines: The re

plan of writing ncept, sentenc

S, SUB TITLES systematic meips and resultsg Tables: T itle, es: use and gus: Getting starteation, Headingson in writing - D

ERTATION/RESw of Literature, clarify, validity

ublication Man1990): Integratthers. (Ed.) (19

Head of th

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Hrs.rs.

orial09.880.X1.I

derstand importe in writing and

research propos

systematic app

ON OF INFO/opinion, tabula

MMUNICATIOports, Review aasons for prepa(ii) as skeletone and combina

S, TABLES, ILLeans of present. Body stab, Staidelines ed, Use outlines, Content, ClarDrafting and ReSEARCH REP, Methodology,

y internal consi

ual of Americaing Research: 984): Dissernin

SAIL

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D TECHN

tance ofwriting d abstracting sksal or a chapte

proach

ORMATION: ating informatio

N: Different forarticles, Monogaring outlines for the manus

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LUSTRATIONSting data in row

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n Psychologica A Guide for Lit

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RESEARCH METHODOLOGY

Scheme of Instruction Scheme of Examination Total Duration : 30 Hrs. Max. Marks : 50 Hours/Week : 2 Hrs. Assignment : 20 Credits : 2 Attendance : 05 Instruction Mode : Tutorial Seminar : 25 Course Code : PY.09.880.X2.I Exam Duration : 1 Hr.

Course Objectives: To give exposure on how to do literature survey for the project work. To develop technical writing skills in the form of a research report. Course Outcomes: To able to organize the research in an effective fashion

Unit – I : Basics of Research: Definition, objectives, motivation, types of research and approaches; Descriptive research, conceptual, theoretical, applied and experimental. Formation of Research Problem: Research Process: To determine what type of research to be done, plan of research work; Selection of research area, prioritization of research; Literature review: importance and methods, sources; Objectives and scope ofwork, developing research plan and schedule; Scheduling constraints, steps, problems in scheduling, limitations. Experimental Modeling: Definition ofexperimental design, examples, single factor experiments, blockingand Nuisance factors, guidelines for designing experiments; General model of process: Input factors/ variables, Output parameters / variables controllable / uncontrollable variables, dependent / independent variables, experimental validity; Introduction to Risk assessment, reliability, sustainability, and uncertainty.

Unit – II : Analysis of Data: Types of data: parametric and nonparametric, descriptive and inferential data; Collection of data: normal distribution, calculation of co-relation coefficient; Data processing: analysis, error analysis, meaning, and differentmethods; analysis of variance, significance ofvariance, analysis of covariance, multiple regressions, testing linearity/nonlinearity of model, testing adequacy of model; Test to be used in data exploration and their choice; Introduction of software used in data analysis. Research Deliverables: Various Forms of Publication: T hesis, paper, research proposal; Thesis Writing: Introduction, literature review/state-of-the-art, research approach (methodology), results / findings, discussions, conclusions, scope for future work, references, appendices; Presentation: Poster, thesis, proposal, and paper. Ethical and Plagiarism issues in research: Historical perspectives, General principles on ethical consideration involving human participation, General ethical evaluation ofdrugs/ device/ diagnostics/ vaccines/ herbal remedies. Statement of specific principles for human genetics and genomic research. International Conference on Harmonization. Good clinical practices norms, Ethical principles related to animal experiments; Issues related to plagiarism, copyright laws, acknowledging the sources, format for manuscript writing, documentation, organization of reference material, bibliography, end note.

References: 1. C.R. Kothari, 2004. “Research Methodology”. 2nd Ed. New Age International (p) Limited, Publishers. 2. D. Montgomary, 2000. “Design of Experiments”. 5th Ed. Wiley Interscience. 3. K.P. Willkinsion, L. Bhandarkar, “Formulation of Hypothesis”. 3rd ed. Himalaya publishing, Mumbai. 4. Schank Fr, 2008.“Theories of Engineering Experiments”. 2nd Ed. Tata McGraw Hill. 5. J.W. Best and J.V. Kahn, 2006. “Research in Education”. 10th Ed. PHI publication.


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ENREPRENEURSHIP DEVELOPMENT

Scheme of Instruction Scheme of Examination

Total Duration : 30 Hrs. Max. Marks : 50 Hours/Week : 2 Hrs. Assignment : 20 Credits : 2 Attendance : 05 Instruction Mode : Tutorial Seminar : 25 Course Code : PY.09.880.X4.I Exam Duration : 1 Hr.

Course Objectives: To provide conceptual inputs regarding entrepreneurship management. To sensitize and motivate the students towards entrepreneurship management. To orient and impart knowledge towards identifying and implementing entrepreneurship opportunities.

Course Outcomes: To develop managementskills for entrepreneurship management

Unit - I : CONCEPTUAL FRAME WORK: Concept need and process in entrepreneurship development; Role of enterprise in national and global economy; Types ofenterprise – Merits and Demerits; Governmentpolicies and schemes for enterprise development; Institutional support in enterprise development and management; THE ENTREPRENEUR: Dynamics of Entrepreneurial Motivation; Concepts; Developing Entrepreneurial Competencies; Requirements and understanding the process of entrepreneurship development; self- awareness, interpersonal skills, creativity, assertiveness, achievement, factors affecting entrepreneur'’ role.

Unit - II : LAUNCHING AND ORGANISING AN ENTERPRISE: Environmentscanning – Information, sources, schemes of assistance, problems; Enterprise selection, marketassessment, enterprise feasibility study, SWOT Analysis; Resource mobilization - finance, technology, raw material, site and manpower; Costing and marketing management and quality control; Feedback, monitoring and evaluation; Project work – Feasibility report; Planning, resource mobilization and implementation. GROWTH STRATEGIES AND NETWORKING; Performance appraisal and assessment; Profitability and control measures, demands and challenges; Need for diversification; Future Growth – Techniques ofexpansion and diversification, vision strategies; Concept and dynamics; Methods, Joint venture, co-ordination and feasibility study;

References: 1. Akhauri, M.M.P.(1990): Entrepreneurship for Women in India, NIESBUD, New Delhi. 2. Hisrich, R.D & Brush, C.G.(1996) The Women Entrepreneurs, D.C. Health & Co., Toranto. 3. Hisrich, R.D. and Peters, M.P. (1995): Entrepreneurship – Starting, Developing and Managing a New

Enterprise, Richard D., Inwin, INC, USA. 4. Meredith, G.G. etal (1982): Practice of Entrepreneurship, ILO, Geneva. 5. Patel, V.C.(1987): Women Entrepreneurship – Developing New Entrepreneurs, Ahmedabad EDII.


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Laboratory Design, Safety and Management



Course Objectives: To expose them to existing national safety standards To acquaintwith Laboratory Design and Management

Course Outcomes: On Completion of the course the studentwill be able to perform the Experiments as per cGLPnorms.

Unit - I : Lab Design Criteria; Codes, Standards and References; Architectural Considerations, Walls, Doors, Windows, Security, Ceiling, Flooring, Cleanability, Sinks, Storage, Exit Paths, Engineering Considerations – Electrical, Plumbing, Utilities – Air, Water, Steam and Gases, Heating, Ventilation, Air Conditioning and Fume Hoods; Laboratory Furniture Design and Location; General Laboratory Safety Practices; Standard Operating Procedures (SOP’s);

Unit - II : Management of Analytical Laboratory: Organization of Laboratories based on their types, staffing, skill development and training, budgeting and financing, purchase of costly equipment, qualities of laboratory manager and management styles. Laboratory Inspections: Internal inspection, external audit, concepts, preparing for inspections and audits. Reference standards: Types, preparation, containers, labeling, storage and use. Documentation-STPs: Certificate of Analysis (COA.), LaboratoryNote Books: Typical Documents used in a GLP Laboratory including Standard Test Protocols (STP’s),

References: 1. Laboratory Design Guidelines – University of North Carolina, USA 2. Laboratory Design Hand Book 3. Designing and Planning of Laboratories (2009) 4. Laboratory Design and Construction Guidelines (2010) – Departmentof Environment, Health and Safety,

University of South Carolina, USA 5. Laboratory Safety Design Guide,(2007) – Departmentof Environment, Health and Safety, University of

California, USA 6. Laboratory Safety Guidance,(2011) – OSHA, USA

7. Safe Lab (2007) Web site at www.cpsc.gov


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Employability Skills



Course Objectives: To enhance the employability skills of learners with a special focus on presentation skills, group discussion and interview skills. To enable them to improve their soft skills necessary for workplace contexts. To equip them with effective communicative competence for a global reach.

Course Outcomes: Participate in conversations both formal and informal, attend phone calls and interviews successfully. Read different types of texts and Listen to, and understand foreign accents.

Unit - I : SPEAKING SKILLS: Conversationalskills (formaland informal contexts) - telephonic communication, attending job interviews (responding to FAQs) - taking part in GDs - making presentations. WRITING SKILLS: Job applications – cover letter – resume – applying online – writing proposals – e-Mails – letters – reports – memos – minutes – blogging – tweeting – writing recommendations and instructions – writing for publications. READING SKILLS: Vocabularybuilding – speed reading (skimming – scanning) – reading different genres of texts from newspapers to philosophical treatises – criticalreading – effective reading strategies such as reading ‘beyond the lines’, summarizing, graphic organizers and distinguishing facts from opinions. Unit - II : LISTENING/VIEWING SKILLS: Speeches of different nationalities with focus on American and British accent (TED talks, podcasts) – listening to lyrics – lectures – instructions – dialogues – news casting – talk shows – interviews (Hard talk, Devil’s Advocate) SOFT SKILLS: Motivation - persuasive skills – negotiations – time management – emotional intelligence – stress management – creative and critical thinking.

References: 1. Barker, A. Improve Your Communication Skills. New Delhi: Kogan Page India Pvt. Ltd., 2006. 2. Craven, Miles. Listening Extra – A resource book of multi-level skills activities.Cambridge University

Press, 2004. 3. Gammidge, Mick. Speaking Extra - A resource book of multi-level skills activities. Cambridge

University Press, 2004. 4. Hartley, Peter. Group Communication. London: Routledge, 2004. 5. John Seely. The Oxford Guide to Writing and Speaking. New Delhi: Oxford University Press, 2004. 6. Naterop Jean & Rod Revell. Telephoning in English. Cambridge University Press,1987. 7. Ramesh, Gopalswamy and Mahadevan Ramesh. The ACE of Soft Skills. New Delhi: Pearson, 2010.

Web Sources: 1. www.humanresources.about.com 2. www.careerride.com


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