7/29/2019 M.Pharm. - quality assurance syllabus

1/8

O' XE@[O' %P\@BJ]Z @SS\[@GCL*

CD\[SL S][\C]\[L @GM SZBB@K\S

J ZL@[ J SLOLS]L[

Cdml Ardup Sukilct B X Crlmjt

Odmlrg Xe`ro`clutjc`b @g`bytjc`b

]lcegjquls

3 8 3

@mv`gclm Kjdst`tjstjcs gm [lsl`rce

Oltedms

3 8 3

Ndroub`tjdg Mlvlbdpolgt gm Pu`bjty

Cdgtrdb

3 8 3

Addm O`gun`cturjga Xr`ctjcls gm @umjts 3 8 3

Lv`bu`tjdg dn Xe`ro`clutjc`b Mds`al

Ndros

3 8 3

B`k Odmlrg Xe`ro`clutjc`b @g`bytjc`b

]lcegjquls B`k

8 3 ;

B`k Ndroub`tjdg Mlvlbdpolgt gm Pu`bjty

Cdgtrdb B`k

8 3 ;

Slojg`r / / ;

]dt`b Crlmjts ;0

7/29/2019 M.Pharm. - quality assurance syllabus

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ODML[G XE@[O@CL\]JC@B @G@BZ]JC@B ]LCEGJP\LS

%Cdoodg td @bb Kr`gcels*

\gjt J

`' Cdbuog Cerdo tdar`pey9 @msdrptjdg `gm p`rtjtjdg" teldry" prlp`r`tjdg" prdclmurl `gmoltedms dn mltlctjdg

k' ]ejg B`ylr Cerdo`tdar`pey9 ]eldry" prlp`r`tjdg" prdclmurls" mltlctjdg dn cdopdugms

c' X`plr Cerdo`tdar`pey9 teldry" mjnnlrlgt tlcegjquls lopbdylm" njbtlr p`plrs uslm"

qu`bjt`tjvl gm qu`gtjt`tjvl mltlctjdg

`' Cdugtlr currlgt lxtr`ctjdg" sdbjm pe`sl lxtr`ctjdg tlcegjquls" alb njbtr`tjdg\gjt JJ

`' A`s cerdo`tdar`pey9 Jgtrdmuctjdg" nugm`olgt`bs" jgstruolgt`tjdg" cdbuogs9 prlp`r tjdg

`gm dplr`tjdg" mltlctjdg" mlrjv`tjs`tjdg'

k' EXBC9 Xrjgcjpbls `gm jgstruolgt`tjdg" sdbvlgts `gm cdbuogs uslm" mltlctjdg `gm

`ppbjc`tjdgs

\gjt JJJ

`' \^/^jsjkbl splctrdscdpy9 Jgtrdmuctjdg" lblctrdo`agltjc splctruo" `ksdrk`gcl b`ws `gmbjojt`tjdgs" jgstruolgt`tjdg/mlsjag `gm wdrfjga prjgcjpbl" cerdodpedrl cdgclpt"

`uxdcerdols" Qddm/Njselr rubls ndr c`bcub`tjga `ksdrptjdg o`xjouo" `ppbjc`tjdgs dn \^/

^jsjkbl splctrdscdpy

k' J[ splctrdscdpy9 K`sjc prjgcjpbls/Odblcub`r vjkr`tjdgs" vjkr`tjdg`b nrlqulgcy" n`ctdrsjgnbulgcjga vjkr`tjdg`b nrlqulgcjls" s`opbjga tlcegjquls" jgstruolgt`tjdg" jgtlrprlt`tjdg dnsplctr`" N]/J[" teldry `gm `ppbjc`tjdgs

\gjt J^

O`ss splctrdscdpy9 ]eldry" jdgjz`tjdg tlcegjquls9 lblctrdg jop`ct jdgjz`tjdg" celojc`b

jdgjz`tjdg" njlbm jdgjz`tjdg" n`st `tdo kdok`rmolgt" pb`so` mlsdrptjdg" nr`aolgt`tjdg

prdclss9 typls dn njssjdg" rlsdbutjdg" AC$OS" jgtlrprlt`tjdg dn splctr` `gm `ppbjc`tjdgs ndr

jmlgtjnjc`tjdg gm structurl mltlrojg`tjdg

\gjt ^

GO[9 ]eldry" jgstruolgt`tjdg" celojc`b sejnt" sejlbmjga `gm mlsejlbmjga lnnlcts" spbjttjga dn

sjag`bs" spjg/spjg cdupbjga" prdtdg lxce`gal rl`ctjdgs" cdupbjga cdgst`gt%I*" gucbl`r

dvlre`uslr lnnlct%GDL*"03

C

GO[ splctr` `gm jts `ppbjc`tjdgs" ;M/GO[" CDSZ `gm

`ppbjc`tjdgs jg pe`ro`cy

7/29/2019 M.Pharm. - quality assurance syllabus

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[LNL[LGCLS

0'Jgstruolgt`b Oltedms dn Celojc`b @g`bysjs ky K'F Se`ro`

;' Dra`gjc splctrdscdpy ky Z'[ Se`ro`3' @ ]lxt kddf dn Xe`ro clutjc`b @g bysjs ky Flrrlgte @' Cdggdrs

='^dalbs ]lxt kddf dn Pu`gtjt`tjvl Celojc`b @g`bysjs ky @'J' ^dalb

7/29/2019 M.Pharm. - quality assurance syllabus

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@M^@GCLM KJDS]@]JS]JCS . [LSL@[CE OL]EDMS

\gjt/J 9

Mlvlbdpjga rlsl`rce qulstjdg" [lsdurcls ndr rlsl`rce qulstjdg"

Bjtlr`turl [lvjlw9 ]r`mjtjdg`b Pu`bjt`tjvl [lvjlw

Olt`/@g`bysjs@ Pu`gtjt`tjvl [lvjlwXrlp`r`tjdg dn [lsl`rce Xrdpds`b

^`rj`kblsMlnjgjtjdg dn ^`rj`kbl" ]ypls dn v`rj`kblsMlplgmlgt gm Jgmlplgmlgt v`rj`kbls"

Cdgndugmlm v`rj`kbls" Ol`surlolgt dn v`rj`kbls" ]ypls dn ol`surlolgt sc`bls gm teljr

cdop`rjsdg' [lbj`kjbjty gm `bjmjty dn Ol`surlolgts'

\gjt/JJ 9

^`bjmjty" ]ypls dn v`bjmjtyJgtlrg`b v`bjmjty" Cdgstruct v`bjmjty" Lxtlrg`b v`bjmjty" ]erl`ts td v`bjmjty'

Cdgtrdb9 Sukilct s dwg cdgtrdb %Qjtejg Sukilct cdgtrdb*" St`tjstjc`b cdgtrdb'

\gjt/JJJ9

Gdg/lxplrjolgt`b [lsl`rce9

X`rt 0Dkslrv`tjdg`b" @rcejv`b gm C`sl/Stumy [lsl`rce9 ]el Elrolglutjc @pprd`ce'

Dkslrv`tjdg`b [lsl`rce9 G`tur`bjstjc Dkslrv`tjdg" X`rtjcjp`gt/Dkslrvlr [lsl`rce'

@rcejv`b [lsl`rce9 @rcejv`b M`t` Cdbblctjdg gm Cdopjb`tjdg'

C`sl Stumjls9 Ce`r`ctlrjstjc dn C`sl Stumjls'

Gdg/lxplrjolgt`b [lsl`rce9 Survly [lsl`rceMlsjagjga dn Pulstjdgg`jrl" Oltedms dn

@mojgjstr`tjdg" [lspdgsl [`tls' ]ypls dn S`opblsE`pe`z`rm S`opbls" Xurpdsjvl S`opbls"

Cdgvlgjlgcl S`opbls gm Xrdk`kjbjty S`opbls'

\gjt/J^ 9

]rul Lxplrjolgts9 Sjgabl/N`ctdr Mlsjags" N`ctdrs" Blvlbs" Cdgmjtjdgs" `gm ]rl`tolgts' Qjtejg/

Sukilct Mlsjags'

]rul Lxplrjolgts X`rt/;N`ctdrj`b MlsjagsO`jg Lnnlcts" Jgtlr`ctjdgs" @ Ojxlm N`ctdrj`b Mlsjag'

\gjt ^ 9

Sjgabl/Sukilct Lxplrjolgts9 @mv`gt`als gm Mjs`mv`gt`als'

Pu`sj Lxplrjolgts9 ]el mjnnlrlgcls kltwllg Pu`sj gm ]rul Lxplrjolgts'

Mlsjag wjtedut Cdgtrdb ArdupsJgtlrruptlm ]jol Slrjls Mlsjags `gm [lpl`tlm ]rl`tolgt Mlsjags'

Xrlscrjklm ]lxt Mdg`bm E' OcKurgly

]elrls` B' Qejtl [lsl`rce Oltedms % Clga`al bl`rgjga Jgmj` Xvt' Btm*

7/29/2019 M.Pharm. - quality assurance syllabus

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ND[O\B@]JDG ML^LBDXOLG] @GM P\@BJ]Z CDG][DB

\gjt J

O`gun`cturjga `gm Pu`bjty cdgtrdb dn sdbjm mds`al ndros9 ]`kblts `gm C`psubls' Bjqujm

Mds`al ndros9 dr`b gm tdpjc`b

\gjt JJ

X`rlgtlr`bs9 Ndroub`tjdg mlvlbdpolgt `gm lv`bu`tjdg" @lrdsdb ndroub`tjdg Mlvlbdpolgt

`gm jts qu`bjty cdgtrdb'

\gjt JJJ

Slblctjdg `gm lv`bu`tjdg dn p`cf`ajga o`tlrj`b" cdgt`jglrs `gm cbdsurls" splcj`b prdkblos dn

cdgt`jglrs `gm cbdsurls" splcj`b prdkblos jgtlr`ctjdgs' Xe`ro`cdlpj`b splcjnjc`tjdgs" tlsts `gm

st`gm`rms ndr p`cf`ajga o`tlrj`b

\gjt J^

Stlrjbjty tlstjga dn pe`ro`clutjc`b prdmucts9 /Xeysjcd celojc`b n`ctdrs `nnlctjga st`kjbjty dn

mruas" oltedms td njgm dut mlar`m`tjdg p`te w`ys'

\gjt ^

`' Mltlrojg`tjdg dn selbn bjnl ky @cclblr`tlm st`kjbjty tlstjgak' Jgcdop`tjkjbjtjls lgcdugtlrlm jg mrua oubtj cdopdglgt ndroub`tjdg" r`tjdg`bl ndr

mrua cdokjg`tjdg c`sl stumjls'

]LU] KDDFS0' Algg`rd @'['[lojgatdg tel scjlgcl gm pr`ctjcl dn pe`ro`cy';8te lmjtjdg" vdbuol

0.;" Bjppjgcdtt Qjbbj`os `gm Qjbbfjgs Xelblmlbpej`" X@" ;888'

;' B`ceo`g `gm Bjklro`gg" tel teldry `gm pr`ctjcl dn jgmustrj`b pe`ro`cy" tejrm Lmjtjdg"^lrajs pukbjsejga Edusl" Ouok`j 0::0'

3' K`gflr AS `gm [edmls C]" odmlrg pe`ro`clutjcs" tejrm lmjtjdg" O`rclb Mlfflr" Jgc" GlwZdrf 0::

[LNL[LGCLS

0' B`ceo`g B" lt `b" pe`ro`clutjc`b mds`al ndros" t`kblts" slcdgm lmjtjdg" vdbuol 0";" `gm 3"O`rclb Mlff`r" Glw Zdrf 0::;'

;' B`ceo`g B' L t ` J Xe`or`clutjc`b mds`al ndros p`rlgtlr`b olmjc`tjdg slcdgm lmjtjdg^dbuol 0 `gm ; O`rclb Mcdr Glw Zdrf 0::;'

3' ]urcd S`gm Fjga [L" stlrjbl mds`al ndros" tejrm lmjtjdg Bl` `gm Nlkjalr" Xejb`mlbpej`0:51'

7/29/2019 M.Pharm. - quality assurance syllabus

6/8

ADDM O@G\N@C]\[JGA X[@C]JCLS @GM @\MJ]S

\gjt J

AOX alglr`b cdgsjmlr`tjdgs `gm mlnjgjtjdgs" @jos . Dkilctjvls dn AOXs" AOX

rlqujrlolgts ndr ctjvjtjls dn o`gun`cturjga$ p`cf`ajga$ b`klbjga" tlstjga

\gjt JJ

Jgtrdmuctjdg td AOXs/OE[@" AOXs/EXNKJ" AOXs/OCC" AOXs/LMPO" ltc'

JCE P1@" AOXs ndr @XJs

\gjt JJJ

@umjts9 AOX cdopbj`gcl `umjt" Mlnjgjtjdg Suoo`ry" @umjt pdbjcy" Jgtlrg`b `gm Lxtlrg`b

@umjts" Slcdgm X`rty @umjts" Lxtlrg`b tejrm p`rty umjts

\gjt J^

Xrlp`r`tjdg ndr @umjt" Cdgmuctjga umjt" umjt g`bysjs" umjt rlpdrt" `umjt ndbbdw up"

\gjt ^

@ typjc`b jgtlrg`b @umjt [lpdrt %Njrst p`rty*" Lxtlrg`b %Slcdgm p`rty* @umjt [lpdrt ]ejrm p`rty

`umjt rlpdrt

]LU] KDDFS 9

0' Edw td pr`ctjcl AOX" 0st

Lmjtjdg" X'X' Se`ro`

;' Addm B`kdr`tdry Xr`ctjcls" Slbjlr" Iura X

3' Addm X`ero' O`gun`cturjga Xr`ctjcl [`tjdg`b gm Cdopbj`gcl" Ideg Se`rp

S\AALS]LM [LNL[LGCLS9

0' ]el A`zlttl dn Jgmj`" Lxtr` drmjg`ry" Glw Mlbej

;' @ ]lxt kddf dn Ndrlgsjc Xe`ro`cy ky Ojte`b

3' QED ]lcegjc`b [lpdrt Sljls" Gd'':85";883

=' Pu`bjty @ssur`gcl dn Xe`ro`clutjc`bs

7/29/2019 M.Pharm. - quality assurance syllabus

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L^@B\@]JDG DN XE@[O@CL\]JC@B MDS@AL ND[OS

\gjt J

Mlt`jblm stumy dn tel prjgcjpbls gm prdclmurls jgvdbvlm jg v`rjdus peysjcdcelojc`b

oltedms dn `g`bysjs dn Xe`ro`clutjc`b mds`al ndros klbdga td tel ndbbdwjga cb`ssls dn mruas'

@' Subpedg`ojmls K' @gtjkjdtjcs C' @gtj/ ejst`ojgls M' ^jt`ojgs

\gjt JJ

@ mlt`jblm stumy dg tel prjgcjpbls `gm prdclmurls jgvdbvlm jg tel mltlrojg`tjdg dn tel

mds`al ndros dn tel ndbbdwjga ardup dn mruas

@' @mrlglrajcs K' @gtj/ o`b`rj`bs C' Stlrdjms M' @g`balsjcs gm `gtjpyrltjcs

\gjt JJJ

Dnnjcj`b oltedms dn mltlrojg`tjdg ndr tel olgtjdglm klbdw pe`ro`clutjc`b mds`al ndros dn tel

ndbbdwjga ardup dn mruas

@' Bdc`b `glsteltjcs K' K`rkjtur`tls C' @gtj/mj`kltjcs M' Mjurltjcs

\gjt J^

^`rjdus jg prdclss Pu`bjty Cdgtrdb tlsts c`rrjlm dg tel ndbbdwjga dn Mds`al Ndros

@' ]`kblts K' C`psubls C' Jgilct`kbls M' Bjqujm Dr`bs

\gjt ^

@ mlt`jblm stumy dg tel kjdbdajc`b lv`bu`tjdg dn tel ndbbdwjga mds`al ndros

@' [`kkjs ^`ccjgl K' Dxytdcjg C' ]lt`gus @gtjtdxjg

\gjt ^J

Ojcrdkjdbdajc`b lv`bu`tjdg dn tel ndbbdwjga mds`al ndros

@' Gldoycjg Subpe`tl K' Cy`gdcdk`b`ojg C' Mjpetelrj` `ccjgl

[lcdoolgmlm Kddfs9

`' [lojgatdgs Xe`ro`clutjc`b Scjlgcls ky @bndgsd gm Algg`rdk' Ojcrdkjdbdajc`b @ss`ys ky K`rtdg I' Qrjaetc' Xe`ro`clutjc`b Celojstry ky Klcflt `gm St`gb`flm' Pu`gtjt`tjvl @g`bysjs dn Mruas jg Xe`ro`clutjc`b Ndroub tjdgs ky X'M'Sltejl' Xe`ro`clutjc`b @g`bysjs ky Ejaucej" Klceoo`g gm E`ss`gn' ]eldry gm Xr`ctjcl dn Jgmustrj`b Xe`ro`cy ky Bjlklro`g gm B`ceo`ga' Jgmj`g Xe`ro`cdpdlj` 0::>

7/29/2019 M.Pharm. - quality assurance syllabus

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ODML[G XE@[O@CL\]JC@B @G@BZ]JC@B ]LCEGJP\LS B@K

%Cdoodg td @bb Kr`gcels*

0' \sl dn splctrdpedtdoltlr ndr g`bysjs dn Xe`ro`cdpdlj`b cdopdugms gm teljr ndroub`tjdgs

;'Sjoubt`gldus mltlrojg`tjdg dn cdokjg`tjdg ndroub`tjdgs %Ojgjouo dn 8= lxplrjolgts*

3' Lnnlct dn pE `gm sdbvlgt dg \^ splctruo dn clrt`jg mruas=' Lxplrjolgts dn Cerdo`tdar`pey

`' ]ejg b`ylr cerdo`tdar`pey

k' X`plr cerdo`tdar`pey9 @sclgmjga" Mlsclgmjga" cjrcub`r `gm twd/mjolgsjdg`b tlcegjquls