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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
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2
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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
versity
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
nceSpectroscecoupling, shieon PMR. Interp
principles Maecular ion, metaules, Relative aermination.
ques: General omatographyatrumentation, C
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d modern techns, the procedu
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photometers ann of IR spectra.
copy: Fundamelding, de-shielpretation of PM
ass Spectrometastable ions, frabundances of
Principles, Cland Column Ch
Column efficien
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try. Ionization tragment ions; ff isotopes and t
assification of hromatographyncyparameters
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L TECHNI
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ss spectrum Mc-Lafferty ristic peaks
Thin Layer chanism .
plications in
g Materials, al Analysis.
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G.Pulla Reddy College of Pharmacy
Hyderabad
Chairp
Unit
ElectElectElectRadiELISA
UnitX- RacrystaTherBoo
1
2
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2000.
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an, Organic spe Delhi, 2005. KA. A Text booH, Merritt LL, Detors, New Delh Lampman GM
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and ApplicatioEF), ContinuouBlotting T echnGeneral Princion for Analysis
aspects ofcrystder diffraction,
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G.Pulla Reddy College of Pharmacy
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Scheme of Total DuratiHours/WeekCredits Instruction MCourse Cod
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
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Unit - III :Solubility: Imsolubility, phasDissolution: Factors influetesting for comedia, in-vitro
Unit - IV :Chemical StaStability TestinProduct Stabinfluencing-meTablets). Solid
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BoS
ACEUTIC
60 Hrs. 4 Hrs. 4 Lecture PY.09.886.1
theoretical knoarious physicao be studied an
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and Producecifications, Pr
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age forms and is of raw matet development.
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its stability.erials, drug
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nts, directly pients, flow
on, intrinsic
d non-sink. dissolution
Bio-relevant
cal Stability,
cals, factors ata (API &
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G.Pulla Reddy College of Pharmacy
Hyderabad
Chairp
UnitGeneAct, DeveNoveNano
Boo1.
2. 3.
4.
5. 6. 7.
8.
9. 1011
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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
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dissolution testn Pharmaceuti
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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
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Pharmaceutica– ANDA, Gen
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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
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2003.
5
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axman roduct
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2006. CBS
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. 005. New
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QUA
Scheme of Total DuratiHours/WeekCredits Instruction MCourse Cod
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
Instruction ion : k :
: 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
Vaccines: DiphEnzymes: StreAntitoxins: DipHormones: Ch
: trol of Nutrac
: trol of Food n of Moisture, A (Milk Powder,
Referencescial’s Manual on
BoS
ONTROL
60 Hrs. 4 Hrs. 4 Lecture PY.09.885.1
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
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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
LTH REL
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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in, Insulin.
B2, B12, C, D,
es, Proteins anConstituents. G).
., Commercial
nt
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SchemeMax. MMid SeQuizEnd SemExam D
l tests for anals knowledge wirocedures and
acquainted witntioned in the a
nd hair dyes), bg creams, after
WHO guidelinesactivity, swellined drugs, and
llowing.
E and K), Mic
nd Fats with SGeneral Analyti
Law Publishers
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lysis of cosmetill be helpful in different guide
th application oabove units.
baby care prodshave lotions a
s) - Determinang index, foam micro-chemic
cro Nutrients a
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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,
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G.Pulla Reddy College of Pharmacy
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Chairp
2. SL
3. K4. N5. M
H6. E7. L
P8. R
29. A10.N11.M
212.D13.N
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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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Scheme of Total DuratiHours/WeekCredits Instruction MCourse Cod
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
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BoS
RUMENTA
60 Hrs. 4 Hrs. 4 Lecture PY.09.885.1
giving in-depth on in characteris on applicationraining on use
ndergone this us instrumental cation of these
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andling and Ap
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analytical ty studies.
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Boo1. S
H2. S
S3. W
d4. E5. S6. L7. G8. A
9. W
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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
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ods of Pharmaceutical Analysis
mental Methodsl Drug Analysis
John Wiley & S
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Scheme of Total DuratiHours/WeekCredits Instruction MCourse Cod
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INTELLE
Scheme of Total DuratiHours/WeekCredits Instruction MCourse Cod
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United State
f Packaging Mered glass tesests – plastics,and liquid dosaand rubber clos
erences: Brochmann ENew Delhi, 20
Sheskey PJ, On, 2006. LiebermanHA,Mumbai 1987. uantitative AnaNew Delhi, 20Stenlake JB. New Delhi, 20The Science a2005. macopoeia. Comacopoeia. Bries Pharmacopo
Head of th
Materials: Contst, water atta polyethylene c
age forms, custsures.
E, Hanssen H04.
Owen SC. Han
Kanig JL. The lysis of Drugs 08. Practical Phar04.
and Practice of
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tainers – Glassack test. Biolcontainers, sintomized patien
, Hanseen H.
ndbook of Phar
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in Pharmaceu
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blication. Delhiopoeia Commitates Pharmaco
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s: light transmiogical tests –
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al resistance – nd other poly dose containeainers – perme
CBS Publishe
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glass ymers: ers for eation,
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Scheme of Total DuratiHours/WeekCredits Instruction MCourse Cod
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
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BoS
Biolo
60 Hrs. 4 Hrs. 4 Lecture PY.09.885.
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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
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evaluation methfficial methods of these techn
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patitis VaccineGrouping Seruand Biologica
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nch top and elimination f Oxytocin,
e, Biological um, Human al Assay of
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21
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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.
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s Managemenrsonal hygiene ment: Introductioning; Sewages; Water; Pow
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Osmania Univ
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Books and 1. Gupta S2. Sharma 3. Sharma 4. Quality A
WHO, G5. Basic Te6. The Inte7. Mehra M8. Subrahm9. Quality A
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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.
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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
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Polymers for nd biodegradurgicals, polymposomes, nano
polymers with assive targetingd biologicalresps and intracellu
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dbook ;John wilence, Wiley, NY(2nd ed. ), Wileolecules, John
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CHNOLO
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tissues and cg of polymeric ponsemodifiersular drug delive
er Drugs and R
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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
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Osmania Univ
e Faculty
Examinations : 10ter : 2
: 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
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25
n 00200575
Hrs.
perties thesis sions, , flow
olymer ymers,
and ns of ymeric
olymer on and ts and
ymer
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5. F. W. Billm6. B. D. Ratn
in Medici7. Biomedic8. G. Gebele
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Inc. 14. Academic15. Self-Asse16. P. L. Felg
Chairperson
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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
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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
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mol and Diclofeollowing equipm
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and J.P. Agn Revised &PharmaceuticCurrent Good
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chine rea alytical instrumquipment. drug substance
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ATION
Scheme of EMax. Marks Mid SemesteQuizEnd SemesteExam Duratio
eatability, specif byUV-Visible
Aspirin, Paracet
(2Expts) iumand mercu
Second Edn
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an, Pune. Med Press, Hy
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Osmania Univ
Examination: 10
er : 2: 0
er : 7on : 6
ficity, system Spectroscopya
tamoland Raniti
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, Marcel Dek
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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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4 Chairperson, BoS Head of the Department Dean of the Faculty
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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6 Chairperson, BoS Head of the Department Dean of the Faculty
Laboratory Design, Safety and Management
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.X6.I Exam Duration : 1 Hr.
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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8 Chairperson, BoS Head of the Department Dean of the Faculty
Employability Skills
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.X8.I Exam Duration : 1 Hr.
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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