in process quality control tests for pharmaceuticals

7/23/2019 In process Quality control tests for pharmaceuticals.

1/17

Xuhl`ty Hssurhbajpriajfurjs gir

VhdljtsF@BJQM KZNHTNhbkhrhb Q`bcm

Fjjphk Qmhrnh

Curnjjt Q`bcm

N"_MHTNHAP

_MHTNHAJZV@AQ

AV @bst`tutj ig _mhrnhajut`ahl sa`jbajs

Ehlhbfmhr, @BF@H

H@AVJ , _A@ hpprivjf


2/17

Xuhl`ty

@b nhbughatur`bc, h njhsurj ig jxajlljbaj ir h

sthtj ig dj`bc grjj grin fjgjats, fjgà`jba`js,

hbf s`cb`gàhbt vhr`htìbs, driucmt hdiut dy tmj

stràt hbf aibs`stjbt hfmjrjbaj ti njhsurhdljhbf vjr`g`hdlj sthbfhrfs ti ham`jvj ub`girn`ty

ig iutput tmht sht`sg`js spja`gà austinjr ir usjr

rjqu`rjnjbts"

Xuhl`ty, s`npl`stàhlly, njhbs tmht h prifuat

smiulf njjt `ts spja`gàhtìb"


3/17

Xuhl`ty Hssurhbaj

@t `s tmj sun tithl ig tmj irchb`zjfhrrhbcjnjbts w`tm tmj idejat`vj ig jbsur`bc

tmht prifuats w`ll dj ig tmj quhl`ty rjqu`rjf

gir tmj`r `btjbfjf usj"


4/17

Xuhl`ty ig Vhdljt aiulf dj

jggjatjf dy

Zb`t vhr`hdlj

Zb`t stjp

Zb`t priajss

wm`am aiulf dj jxplh`bjf dy

[email protected] F@HCTHN


5/17

H s`nplj G@QMDIBJ f`hcrhn ig tmj _riajss`bc stjps hbf `b

_riajss vhr`hdljs fur`bc Vhdljt nhbughatur`bc tmht nhy

`bglujbaj tmj quhl`ty hbf aibs`stjbay ig g`bhl prifuat fisj

ub`girn`ty

_TJDLJBF@BC -8.1)

Q_JJFLIHF

V@NJ

VJN_"

FTP@BC -0.88)

Q@UJ

V@NJ

DLJBF@BC -8:.83)

LIHF

V@NJ

Q_JJF

CTHBZLHV@BC -6.=)

Q@U@BC -84.86) VHDLJV@BC -8=.80)

Q_JJF Q_JJF Q_JJFGITAJ

LIHF

THVJ

QATJJB

V@NJ

THVJ

HNIZBV

F

I

Q

J

Z

B

@

GI

T

N

@

V

P


6/17

Ahpp`bc hbf Lhn`bhtìb

_àk`bc hbf Qtàk`bc

Nittl`bc

_iir gliw

_iir n`x`bc

Fiudlj `nprjssìb

_riajss`bc _ridljns

hssia`htjf w`tm Vhdljts


7/17

Xuhl`ty ig thdljts smiulf gulg`ll ajrth`b

spja`gàhtìbs

8" Vmj thdljt smiulf `balufj tmj airrjat fisj ig tmj fruc"

-Sj`cmt ub`girn`ty hbf aibtjbt ub`girn`ty tjst)

4" Vmj fruc smiulf dj rjljhsjf grin tmj thdljt `b h aibtrilljf

hbf rjprifua`dlj why " -F`ssilutìb tjst)

1" Vmj thdljt smiulf smiw suggà`jbt njamhbàhl strjbctm ti

w`tmsthbf grhaturj hbf jrisìb fur`bc nhbughatur`bc hbf

mhbfl`bc" -Mhrfbjss hbf gr`hd`l`ty tjst)

6" Vmj hppjhrhbaj ig tmj thdljt smiulf dj jljchbt hbf `tswj`cmt, s`zj hbf hppjhrhbaj smiulf dj aibs`stjbt "-W`suhl

idsjrvhtìb, wj`cmt vhr`htìb, tmàkbjss hbf f`hnjtjr ig tmj

thdljt)

:" Vmj thdljt smiulf dj phakjf `b h shgj nhbbjr"


8/17

Xuhl`ty aibtril tjsts hbf spja`gàhtìbs

gir sinj ig tmjsj pripjrt`js hrj c`vjb`b pmhrnhaipij`hs" Vmj nist

`npirthbt gir tmjsj hrj;

Sj`cmt ub`girn`ty

Fisj ub`girn`ty

Vmj fruc rjljhsj `b tjrns ig thdljt f`s`btjcrhtìb

hbf fruc f`ssilutìb Tjs`sthbaj ig thdljts ti grhaturj `b tjrns ig

gr`hd`l`ty hbf mhrbjss tjst`bc

Vmj nàrid`hl quhl`ty ig tmj prifuat


9/17

Vmjsj ghatirs nust dj aibtrilljf fur`bc prifuatìb

-`b.priajss aibtril) hbf vjr`g`jf hgtjr prifuatìb"

Qinj tjst njtmifs hrj fjsar`djf `b tmj

pmhrnhaipj`hs; itmjrs hrj bit hbf tmus hrj rjgjrrjf ti

hs $bib.ainpjbf`hl$ tjsts"

H phrt ig Ciif Nhbughatur`bc _rhatàj -CN_),

tmj prifuatìb rub `s nib`tirjf ubfjr

aibtril amhrt" Ht rjculhr `btjrvhls -8?.8:

n`b") fur`bc tmj aiursj ig nhbughatur`bc,

tmj ipjrhtir nust shnplj spja`g`jf bundjr

ig thdljts gir tjst`bc -`b.priajss aibtril) j"c"

wj`cmt ig thdljt, thdljt tmàkbjss, gr`hd`l`ty,

f`s`btjcrhtìb t`nj,


10/17

Iggà`hl Xuhl`ty aibtril tjsts gir thdljts

-Ainpjbf`hl tjsts)

Dr`t`sm _mhrnhaipij`h -D"_") ' ZQ _mhrnhaipij`h

-ZQ_)

8. Zb`girn`ty ig aibtjbt ig hat`vj `bcrjf`jbt

-Zb`girn`ty ig wj`cmt ' Aibtjbt ub`girn`ty)

4. F`s`btjcrhtìb tjst"

1. F`ssilutìb tjst"

6. Gr`hd`l`ty tjst"

ZQ_ njbtìbs sinj X"A" tjsts djgirj tmj piwfjr `s

ainprjssjf

j"c" piwfjr g`bjbjss, fjbs`ty,


11/17

@. Ainphbf`hl tjsts

8. Zb`girn`ty ig hat`vj `bcrjf`jbt

Vrhf`tìbhlly, fisj vhr`htìb djtwjjb thdljts `s tjstjf `b twi sjphrhtj tjsts;

8. Sj`cmt ub`girn`ty

4. Aibtjbt ub`girn`ty

@g tmj fruc girns crjhtjr phrt ig tmj thdljt, hby vhr`htìb `b tmj thdljt

wj`cmt idvìusly `bfàhtjs h vhr`htìb `b tmj hat`vj `bcrjf`jbt"-Sj`cmt

ub`girn`ty tjst)

@g tmj fruc `spitjbt -ZQ_ spja`g`js :? nc ig tmj hat`vj `bcrjf`jbt ir ljss),tmj jxa`p`jbts girn tmj crjhtjr phrt ig tmj thdljt wj`cmt hbf tmj

airrjlhtìb djtwjjb tmj thdljt wj`cmt hbf hniubt ig tmj hat`vj

`bcrjf`jbt ahb dj piir, `b tm`s ahsj hbitmjr tjst -Aibtjbt ub`girn`ty)

nust dj pjrgirnjf"


12/17

H" Sj`cmt ub`girn`ty -D"_" fjs`cb)

Sj`cm 4? thdljts `bf`v`fuhlly -`"j" fjtjrn`bj tmj

wj`cmt ig jham thdljt hlibj; ]8, ]4, ]1

]4?)

Ahlaulhtj tmj hvjrhcj wj`cmt ig thdljts

- > Vithl wj`cmt ig thdljts )

Bundjr ig thdljts

Hvjrhcj wj`cmt ig thdljts -]) > -]8+]4

+]1++ ]4?)4?


13/17

D" Aibtjbt ub`girn`ty

ZQ_ fjg`bjs aibtjbt ub`girn`ty tjst gir thdljts aibth`b`bc

:? nc ir ljss ig fruc sudsthbaj `b ahsj ig ubaihtjf

thdljts hbf gir hll suchr aihtjf thdljts rjchrfljss ti tmj

fruc aibtjbt"

ZQ_ fjs`cb5

Vjb thdljts hrj `bf`v`fuhlly hsshyjf gir tmj`r aibtjbt

-haairf`bc ti tmj njtmif fjsar`djf `b tmj `bf`v`fuhl

nibicrhpm) Vmj rjqu`rjnjbts gir aibtjbt ub`girn`ty hrjnjt `g tmj hniubt ig tmj hat`vj `bcrjf`jbt `b jham thdljt

l`js w`tm`b tmj rhbcj ig =:.88: * ig tmj lhdjl alh`n"


14/17

Bib.Ainphbf`hl tjsts

Vmjrj hrj nhby tjsts hrj grjqujbtly hppl`jf ti

thdljts gir wmàm tmjrj hrj bib.pmhrnhaipij`hl

rjqu`rjnjbts dut w`ll girn h phrt ig

nhbughaturj#s iwbjr prifuat spja`gàhtìbs"

8. Vhdljt tmàkbjss

4. Vhdljt mhrfbjss


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17/17

VMHBK PIZ

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