Download - cGMP regulations of Sterile Products
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_`j`r`ab`
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_`k`zday _`gpkdyefa=
_`gpkdyefa jfr y`rek` srfipby dr` gez`a
pai`r _@GPKDYEFA B!3?!3?5 opy R`sdrdy`
Sdbleag dai kdo`keag fj h`rn`yebdkku `dk`isrfipby dr` bfz`r`i pai`r _@GPKDYEFA
B!3?!344
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Rbfs`=
Ry`rek` srfipby dr` pb`syeok` yf sdryebpkdy`+
surfg`aeb dai nebrfoefkfgebdk bfaydneadyefa!Ip` yf h`dkyh hd}dri dfbedy`i weyh yh` p`fj bfaydneady`i y`rek` srfipby+ s`bedk
sr`bdpyefa dr` r`tper`i ea yh` srfipbyefa fjyh`` y`rek` srfipby!
Ea fri`r yf dbhe`z` yh` Tpdkeyu fj yh`srfipby+ srfipbyefa npy jfkkfw bdr`jpkku
`ydokeh`i dai zdkeidy`i n`yhfi fjsr`sdrdyefa dai Ry`reke}dyefa!
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Bfayeap`i
Yh`` r`gpkdyefa h`ks ea jfkkfweag yh`
zdkeidy`i n`yhfi fj sr`sdrdyefa dai
y`reke}dyefa fj y`rek` srfipby dai foydeaeag d
tpdkeyu srfipby!
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Jdbyfr bfaei`r`i jfr i`egaeag yh`` _`gpkdyfru
srfb`ipr` yf dbhe`z` y`rekeyu dr`
Der ofra` nebrffrgdaen
Sdryebpkdy` ndyy`r
Re}` dai Fs`aeag fj yh` Bfaydea`r ea whebhy`rek` srfipby dr` sr``ay
K`agyh fj yen` bfay`ay dr` `xsf`i
Dprdab` yhdy dkk yh` ndy`redk e `xsf`i yf
y`reke}dyefa bfaieyefa fr srfb`
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_`gpkdyefa fj Ry`rek` srfipby jdkk pai`r
G`a`rdk r`gpkdyefa
_`gpkdyefa jfr sr`ne`
_`gpkdyefa jfr @tpesn`ay
_`gpkdyefa fj Wdy`r uy`n yr`dyn`ay
S`rfaa`k r`gpkdyefa
Rdaeydyefa r`kdy`i r`gpkdyefa
_`gpkdyefa jfr Ndapjdbypreag bfayrfk
_`gpkdyefa jfr Tpdkeyu bfayrfk
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G`a`rdk r`gpkdyefa
Dkk Dtp`fp.od`i y`rek` srfipby npy o`pom`by`i yf Y`rneadk y`reke}dyefa
Y`rneadk Ry`reke}dyefa bda o` `x`nsy`i wh`aRy`reke}dyefa srfb` wfpki bdp` srfipby fr
sdbldgeag i`grdidyefa
D`syeb srfb`` yhdy `xbkpi` hpndaeay`rz`ayefa+ srfzei`i yhdy yh` idyd i`z`kfs`ijrfn srfipby i`nfayrdy` da dbb`sydok` k`z`kfj y`rekeyu dprdab`
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Odeb @azerfan`aydk Rydaidri jfr ndapjdbypreag
Ry`rek` SrfipbyGrdi` Dy r`y Ea fs`rdyefa
Ndxenpn s`rneyy`i " fj sdryebk`&n2 `tpdk yf fr dofz`
3!0 n 0 n 3!0 n 0 n
D 20?3 ?3 20?3 ?3
O 20?3 ?5 20?333 ?533
B 20?333 ?533 20?3333 ?5333
I 20?3333 ?5333 Afy i`jea`i Afy i`jea`i
Dy r`y= Bfaieyefa wh`r` yh` eaydkkdyefa fj `tpesn`ay e bfnsk`y` dai r`diu yf
p`+ opy afy ea P`!
Ea Fs`rdyefa= Bfaieyefa whebh kdy payek dkk yh` sr`i`jea`i brey`red hdz` n`y weyh
yh` @tpesn`ay dai s`rfaa`k ea skdb`!
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Y`rneadk Ry`reke}dyefa= Yh` srfb` fj y`reke}eagndy`redk dai bfaydea`r ifa` weyh yh` ndy`redk
ea ey bfaydea`r+ e!`!+ weyh yh` srfipby ea ey jeadk
jfrn! Bfayrdy weyh d`syeb jekkeag fr sdbldgeag+ea whebh yh` eaiezeipdk bfnsfa`ay dr` y`reke}`i
`sdrdy`ku dai orfpghy yfg`yh`r ea yh` jeadk
jfrn ea d y`rek` `azerfan`ay!
hyys=&&www?!eayfyd!bfn&`xs`ry!ds6yrR`drbhYus`>dkk*yrTp`ru>y`rneadk,y`reke}dyefa
http://www2.intota.com/experts.asp?strSearchType=all&strQuery=terminal+sterilizationhttp://www2.intota.com/experts.asp?strSearchType=all&strQuery=terminal+sterilization -
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Irpg pom`by yf Y`rneadk y`reke}dyefa
Jfrnpkdyefa yhdy ydl` skdb` ea d neaenpn Grdi` B `azerfan`ay
Sdr`ay`rdk jekk`i ea da d`syeb dr`d fr Grdi` B ej yh` srfb` fr
srfipby if` afy sf` hegh rel fj Bfaydneadyefa (hegh rel eypdyefa kfw jekkeag fs`rdyefa+ wei` a`bl`i bfaydea`r `yb!+%
Irpg afy pom`by yf y`rneadk y`reke}dyefa
Sdr`ay`rdk y`reke}`i ou jekyrdyefa!
Ry`rek` Jekyrdyefa r`tper` d neaenpn jeky`r rdyeag fj3!? n! Yh`eay`greyu fj yh` jeky`r e z`reje`i o`jfr` dai djy`r p` ou dssrfsredy`n`yhfi pbh d opook` sfeay+ iejjpefa fr sr`pr` sfeay y`y!
Afa.sdr`ay`rdk srfipby jfrnpkdy`i ea bkf`i uy`n
Irpg afy pom`by yf jekyrdyefa fr y`rneadk y`reke}dyefa
Irpg yhdy dr` srfipb`i jrfn y`rek` rdw ndy`redk dai sdbldgeagbfnsfa`ay ea da d`syeb dr`d pai`r kfbdk Grdi` D bfaieyefa weyh dGrdi` O odblgrfpai!
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_diedyefa y`reke}dyefa e p`i ndeaku jfr h`dy.
`aeyez` ndy`redk!
@yhuk`a` fxei` y`reke}dyefa e p`i wh`a
fyh`r n`yhfi dr` afy srdbyebdok`! @zei`ab`
npy o` dzdekdok` yf hfw yh` do`ab` fj dauidndgeag `jj`by fa yh` irpg wh`a yhe
n`yhfi e p`i!
PZ rdiedyefa e afy da dbb`sydok` n`yhfi fjy`reke}dyefa!
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_`bfnn`ai`i keney jfr Nebrfoedk bfaydneadyefa
Grdi` Der dnsk`
bfkfau jfrneagpaey bjp&n2
R`yyk` skdy`
(iedn`y`r53nn%+ bfkfau
jfrneag paey
(bjp&9 hfpr%
Bfaydby skdy`
(iedn`y`r00nn%+ bfkfau
jfrneag paey
(bjp&skdy`%
Gkfz` sfeay (0
jeag`r% bfkfaujfrneag paey
(bjp&gkfz`%
D ;4 ;4 ;4 ;4
O 43 0 0 0
B 433 03 ?0 .
I ?33 433 03 .
Ej yh` keney dr` `xb``i`i+ fs`rdyeag srfb`ipr` hfpki sr`breo` eaz`yegdyefa
dai bfrr`byez` dbyefa!
Nfaeyfreag e bfaipby`i djy`r breyebdk fs`rdyefa dr` bfnsk`y`!
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hyys=&&www!nfadbfhebl`u!bfn!dp&d`y&Pskfdi&Vr`dnsk`i&R`yWeiyh:83.endg`9!sag
Sr`ne`
http://www.monacohickey.com.au/assets/Uploads/_resampled/SetWidth680-image4.pnghttp://www.monacohickey.com.au/assets/Uploads/_resampled/SetWidth680-image4.pnghttp://www.monacohickey.com.au/assets/Uploads/_resampled/SetWidth680-image4.pnghttp://www.monacohickey.com.au/assets/Uploads/_resampled/SetWidth680-image4.png -
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Sr`ne`=
Yf yh` sfeok` `xy`ay+ sr`ne` dr` i`ega`i yf dzfeipaa`b`dru `ayru fj ps`rzefru fr bfayrfk s`rfaa`k
Yf sr`z`ay yh` h`iieag fr dbbpnpkdyefa fj ipy daifyh`r sdryebpkdy` ndyy`r+ b`ekeag+ jkffr dai wdkk ea
d`syeb dr`d+ hdz` nffyh ens`rzefp prjdb` yhdys`rney yh` r`s`dy`i dsskebdyefa fj bk`daeag daiieeaj`byeag dg`ay!
Jdk` b`ekeag dr` `dk`i yf sr`z`ay bfaydneadyefa jrfnyh` sdb` dofz` yh`n!
Hdai wdheag jdbekeye` dr` srfzei`i faku ea bhdageagrffn
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Bfayeap`i!
Dbb` yf bk`da dai d`syeb dr`d e srfzei`i faku yhrfpghder kfbl!
Yh` der jfr d`syeb dr`d e psske`i yhrfpgh jeky`r fj
peydok` `jjebe`abu kel` H@SD jeky`r!
Ea breyebdk dr`d+ H@SD jeky`r hfpki o` k`dl y`y`i dy k`dyyweb` d u`dr!
Sr`pr` iejj`r`ayedk o`yw``a d`syeb dr`d dai dimdb`aydr`d hfpki o` nfaeyfr`i bfayeapfpku dai ifbpn`ay`i!Wdraeag uy`n hfpki dk`ry s`rfaa`k wh`a yh`` jdkko`kfw ydokeh`i keney!
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@tpesn`ay=
@tpesn`ay i`ega`i ea pbh d wdu d yf jdbekeydy` bk`daeag+ieeaj`byefa+ fr y`reke}dyefa!
Yf yh` `xy`ay sfeok`+ `tpesn`ay jeyyeag dai `rzeb` dr`i`ega`i dai eaydkk`i f yhdy fs`rdyefa+ ndeay`adab`dai r`sder bda ydl` skdb` fpyei` bk`da dai d`syeb dr`d!
Dkk `tpesn`ay+ eabkpieag y`reke}`r+ der.jekyrdyefa uy`n+dai wdy`r yr`dyn`ay uy`n+ dr` pom`by yf skdaa`indeay`adab`&zdkeidyefa< yh` dssrfzdk jfr p` fj`tpesn`ay e ifbpn`ay`i!
Z`ay jeky`r p`i fa ydyefadru `tpesn`ay pbh d wdy`rjfr eam`byefa (WJE% yfrdg` ydal dai j`ryeke}`r+ dain`norda` jeky`r dr` p`i yf jeky`r bfnsr``i gd`+hfpki o` eay`greyu y`y`i srefr yf eaydkkdyefa dais`refiebdkku yh`r`djy`r!
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Wdy`r Yr`dyn`ay uy`n=
Wdy`r yr`dyn`ay jdbekeye` dr` i`ega`i+ bfayrpby`i+dai ndeaydea`i f d yf `apr` yh` r`kedok`srfipbyefa fj wdy`r fj da dssrfsredy` tpdkeyu!
Spreje`i wdy`r e p`i d j``i wdy`r jfr WJE uy`ndai jfr bk`da y`dn g`a`rdyfr! WJE e srfipb`i`eyh`r ou ieyekkdyefa fr ou r`z`r` fnfe!
WJE e p`i ea yh` jfrnpkdyefa fj sdr`ay`rdk+
Erregdyefa dai eayrd fbpkdr srfipby! Spreje`i wdy`rndu o` p`i ea yh` jfrnpkdyefa fj fshyhdknebsrfipby!
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Bfayeap`i
Dk`ry dai dbyefa keney hfpki o` `ydokeh`ijfr odby`redk `aifyfxea dai nebrfoedk kfdi!Yh`` keney hfpki n``y dau ydaidri key`i
pai`r Rbh`ipk` O yf yh` Jffi dai Irpg Dby! Ry`reke}dyefa fr r`g`a`rdyefa fj wdy`r uy`n
e bdrre`i fpy dbbfrieag yf d sr`i`y`rnea`ibh`ipk` dai dkf wh`a`z`r `ydokeh`inebrfoedk bfpay dr` `xb``i`i weyhea dau fjyh` rury`nr bfnsfa`ay!
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S`rfaa`k=
Ea diieyefa yf yh` r`gpkdyefa pai`r _`gpkdyefa
B!3?!33:+ yh` s`rfaa`k r`sfaeok` jfr yh`jdorebdyefa dai y`yeag fj y`rek` srfipby hdz`hdi yrdeaeag ea nebrfoefkfgu!
Hegh ydaidri fj s`rfadk huge`a` daibk`dakea` dr` ndeaydea`i! S`refieb h`dkyhbh`bl jfr pbh bfaieyefa dr` bfaipby`i daidssrfsredy` dbyefa e ydl`a!
Wh`a fpyei` s`rfaa`k whf hdz` afy r`b`ez`ipbh yrdeaeag a``i yf o` orfpghy ea+ sdryebpkdrbdr` e ydl`a weyh r`gdri yf yh`er ps`rzeefa!
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Bfayeap`i!!
S`rfaa`k whf hdz` o``a `agdg`i ea yh` srfb`eag fj daendk
yep` dr` afy dkkfw`i yf `ay`r dr`d wh`r` y`rek` srfipbydr` jdorebdy`i pak` regfrfp dai bk`drku i`jea`ii`bfaydneadyefa srfb`ipr` hdz` o``a jfkkfw`i!
Fpyiffr bkfyheag e afy orfpghy eayf yh`` dr`d! S`rfaa`k`ay`reag yh` bhdageag rffn dr` dkr`diu bkdi ea ydaidri
srfy`byez` gdrn`ay i`ega`i jfr jdbyfru jdbekeye`! O`hdzefprdk y`bhaetp` den`i dy ndeaydeaeag y`rekeyu hfpki
o` `nskfu`i ou s`rfaa`k wfrleag ea d`syeb dr`d! Yh``eabkpi`
nfzeag kfwku dai i`keo`rdy`ku
l``seag `ayer` ofiu fpy fj sdyh fj paeier`byefadk derjkfw
dssrfdbheag dau ndaespkdyefa ea d ndaa`r yhdy if` afybfnsrfne` y`rekeyu fj yh` srfipby
Ndeaydeaeag srfs`r gfwa bfayrfk!
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Rdaeydyefa=
Wdkk+ jkffr+ b`ekeag dai `tpesn`ay ea d`syeb dr`ddr` bk`da`i dai wh`a r`tper`i ieeaj`by`i eadbbfridab` weyh d wreyy`a srfb`ipr`!
Ieeaj`byday dai bk`daeag dg`ay yf o` p`i ead`syeb dr`d hfpki o` y`rek`!
Ieeaj`byday dai bk`daeag dg`ay dr` nfaeyfr`i jfrnebrfoedk bfaydneadyefa dai dr` y`rek` wh`a p`iea Grdi` D fr Grdi` O dr`d!
Rsfrebeidk dg`ay hfpki o` p`i eab` ndaubfnnfa ieeaj`byday dr` ea`jj`byez` dgdeay sfr`!
Yh` bk`daeag srfb`ipr` dr` zdkeidy`i+ dai yh`ieeaj`byefa srfb`ipr` dr` nfaeyfr`i!
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Ndapjdbypreag bfayrfk
hyys=&&www!bfkiyr`dnkdo!bfn&endg`&jek`&kufVoeg!msg
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Ndapjdbypreag bfayrfk=
Ipreag dkk srfb`eag ydg`+ sr`bdpyefa dr` ydl`a yf
neaene}` yh` bfaydneadyefa!
Sr`sdrdyefa bfaydeaeag kez` nebrffrgdaen dr`
a`eyh`r ndi` afy yrdaj`rr`i eayf bfaydea`r ea dr`d
p`i jfr srfb`eag fj fyh`r shdrndb`pyebdk srfipby! Yh` nfz`n`ay fj s`rfaa`k e bfayrfkk`i dai
n`yhfiebdk ea fri`r yf dzfei `xb`ez` h`iieag fj
sdryebk` dai frgdaen!
Dryebk` dr` y`reke}`i dai sd`i eayf yh` d`syeb
dr`d ou yh` p` fj ifpok`i.`ai`i y`reke}`r
`tpess`i weyh eay`rkfbleag iffr fr ou fyh`r zdkeidy`i
n`yhfi!
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Wreyy`a ydaidri dr` dzdekdok` s`bejueag yh` der
tpdkeyu+ eabkpieag zedok` dai afa.zedok` bfpay whebh
dr` yf o` ydl`a dy k`dy fab` s`r `z`ru hejy! Yh` eay`rzdk o`yw``a bk`daeag dai y`reke}dyefa fj
bfnsfa`ay d w`kk d y`reke}dyefa dai p`+ e d hfry
d sfeok` dai pom`by yf yen`.keney dssrfsredy` yf yh`
zdkeidy`i yfrdg` bfaieyefa
Yh` nebrfoedk bfaydneadyefa fj srfipby (oefopri`a% e
neaendk srefr yf y`reke}dyefa! Yh` ndxenpn dbb`sydok`
oefopri`a e `ydokeh`i fa d srfipby ou srfipby ode!
Yh` keney e r`kdy`i yf yh` `jjebe`abu fj yh` n`yhfi yf o`
p`i dai yf yh` rel fj surfg`a dai odby`redk
`aifyfxea+ whebh dr` afy r`nfz`i ou y`reke}dyefa!
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Ry`reke}dyefa fj h`dy=
Rpjjebe`ay yen` e dkkfw`i jfr yh` whfk` kfdi yf r`dbh yh`r`tper`i y`ns`rdypr` o`jfr` n`dpr`n`ay fj yh`y`reke}eag yen` o`gea! Sr`bdpyefa dr` ydl`a yf sr`z`aybfaydneadyefa fj y`reke}`i kfdi ipreag bffkeag!
Ry`reke}dyefa fj nfey h`dy=
Ofyh y`ns`rdypr` dai sr`pr` bfayrfk dr` p`i yfnfaeyfr yh` srfb`! Ey`n yf o` y`reke}`i+ fyh`r yhda
srfipby ea `dk`i bfaydea`r dr` wrdss`i+ ej a`b`dru ead ndy`redk yhdy dkkfw yh` r`nfzdk fj der dai s`a`yrdyefafj y`dn!
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Ry`reke}dyefa fj Iru h`dy=
Eabkpi` der berbpkdyefa weyhea yh` bhdno`r dai
ndeay`adab` fj d sfeyez` sr`pr` yf sr`z`ay yh``ayru fj afa.y`rek` der! Dau der dineyy`i sd`yhrfpgh d H@SD jeky`r!
Ry`reke}dyefa ou rdiedyefa=_diedyefa if` e yf o` n`dpr`i ipreag yhey`reke}dyefa! Ifen`y`r dofro`abe` dr` r`diweyhea d s`beje`i yen` s`refi djy`r `xsfpr` yf
rdiedyefa! Ifen`y`r eaiebdyfr dr` p`i yf gez` dtpdayeydyez` n`dpr`n`ay fj if` r`b`ez`i ou yh`srfipby ey`kj!
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Ry`reke}dyefa weyh @yhuk`a` fxei`=
Ier`by bfaydby fj gd dai nebrfoedk b`kk e ``ayedk! Yh`
adypr` dai tpdkeyu fj sdbldgeag ndy`redk bdaegaejebdayku djj`by yh` srfb`! O`jfr` `xsfpr` yf gd+
ndy`redk dr` orfpghy eayf `tpekeorepn weyh yh` hpneieyu
dai y`ns`rdypr` r`tper`i ou yh` srfb`! Jfr `dbh
y`reke}dyefa bubk`+ r`bfri dr` ndi` fj yh` yen` ydl`a yf
bfnsk`y` yh` bubk`!
Dbk`dr zepdk n`da e p`i jfr iejj`r`ayedyeag srfipbyyhdy hdz` afy o``a y`reke}`i jrfn yhf` yhdy hdz`
o``a y`reke}`i! Yh`` zepdk n`da dr` afy eay`ai`i yf
gez` da eaiebdyefa yhdy yh` kfy e y`rek`!
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D`syeb jekkeag Fs`rdyefa= D wreyy`a ydaidri i`ega`i yf y`y yh``jjebe`abu fj yh` fz`rdkk d`syeb jekkeag fs`rdyefa e ndeaydea`i!
D ndyrex dssrfdbh yf srfb` enpkdyefa ndu o` i`z`kfs`i jfr`dbh jekkeag kea`+ dai hfpki eabkpi` `k`n`ay pbh d yh` yus`fj srfipby jekk`i+ ex` fj kfy+ bfaydea`r dai bkfpr`bfajegprdyefa+ jekk zfkpn`+ kea` s``i+ jekkeag kea` bfajegprdyefadai bfnsfa`ay dai y`rek` hfki yen`!
Yh` srfb` enpkdyefa y`y hfpki enpkdy` dkk yh` s`bejebndapjdbypreag y`s+ pbh d srfipby yrdaj`r+ y`rek` jekyrdyefa+jekkeag+ yrdaj`r fj `ne.yfss`r`i zedk yf kufsheke}`r+ yh`kufsheke}dyefa srfb` dai yfss`reag dai brenseag fj zedk!
@z`ru s`rfa whf e afrndkku dkkfw`i yf o` ea jekkeag rffnipreag d`syeb jekkeag fs`rdyefa npy sdryebesdy` ea yh` srfb`enpkdyefa y`y dkfag weyh yh`er afrndk dega`i ipye`!
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