cGMP regulations of Sterile Products

8/2/2019 cGMP regulations of Sterile Products

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2/33

_`j`r`ab`


3/33

_`k`zday _`gpkdyefa=

_`gpkdyefa jfr y`rek` srfipby dr` gezà

pai`r _@GPKDYEFA B!3?!3?5 opy R`sdrdy`

Sdbleag dai kdo`keag fj h`rn`yebdkku `dkìsrfipby dr` bfz`rì pai`r _@GPKDYEFA

B!3?!344


4/33

Rbfs`=

Ry`rek` srfipby dr` pb`syeok` yf sdryebpkdy`+

surfgàeb dai nebrfoefkfgebdk bfaydneadyefa!Ip` yf h`dkyh hd}dri dfbedyì weyh yh` p`fj bfaydneadyì y`rek` srfipby+ s`bedk

sr`bdpyefa dr` r`tperì ea yh` srfipbyefa fjyh`` y`rek` srfipby!

Ea fri`r yf dbhe`z` yh` Tpdkeyu fj yh`srfipby+ srfipbyefa npy jfkkfw bdr`jpkku

`ydokehì dai zdkeidyì n`yhfi fjsr`sdrdyefa dai Ry`reke}dyefa!


5/33

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!


6/33

Jdbyfr bfaei`rì jfr iègaeag yh`` _`gpkdyfru

srfbìpr` yf dbhe`z` y`rekeyu dr`

Der ofra` nebrffrgdaen

Sdryebpkdy` ndyy`r

Re}` dai Fsàeag fj yh` Bfaydea`r ea whebhy`rek` srfipby dr` sr`ày

Kàgyh fj yen` bfayày dr` `xsfì

Dprdab` yhdy dkk yh` ndy`redk e `xsfì yf

y`reke}dyefa bfaieyefa fr srfb`


7/33

_`gpkdyefa fj Ry`rek` srfipby jdkk pai`r

Gà`rdk r`gpkdyefa

_`gpkdyefa jfr sr`ne`

_`gpkdyefa jfr @tpesnày

_`gpkdyefa fj Wdy`r uy`n yr`dynày

S`rfaa`k r`gpkdyefa

Rdaeydyefa r`kdyì r`gpkdyefa

_`gpkdyefa jfr Ndapjdbypreag bfayrfk

_`gpkdyefa jfr Tpdkeyu bfayrfk


8/33

Gà`rdk r`gpkdyefa

Dkk Dtp`fp.odì y`rek` srfipby npy o`pom`byì yf Y`rneadk y`reke}dyefa

Y`rneadk Ry`reke}dyefa bda o` `x`nsyì whàRy`reke}dyefa srfb` wfpki bdp` srfipby fr

sdbldgeag i`grdidyefa

D`syeb srfb`` yhdy `xbkpi` hpndaeay`rzàyefa+ srfzeiì yhdy yh` idyd i`z`kfsìjrfn srfipby i`nfayrdy` da dbb`sydok` k`z`kfj y`rekeyu dprdab`


9/33

Odeb @azerfanàydk Rydaidri jfr ndapjdbypreag

Ry`rek` SrfipbyGrdi` Dy r`y Ea fs`rdyefa

Ndxenpn s`rneyyì " 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`jeaì Afy i`jeaì

Dy r`y= Bfaieyefa wh`r` yh` eaydkkdyefa fj `tpesnày e bfnsk`y` dai r`diu yf

p`+ opy afy ea P`!

Ea Fs`rdyefa= Bfaieyefa whebh kdy payek dkk yh` srì`jeaì brey`red hdz` n`y weyh

yh` @tpesnày dai s`rfaa`k ea skdb`!


10/33

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 bfnsfaày dr` y`reke}ì

`sdrdy`ku dai orfpghy yfg`yh`r ea yh` jeadk

jfrn ea d y`rek` àzerfanày!

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


11/33

Irpg pom`by yf Y`rneadk y`reke}dyefa

Jfrnpkdyefa yhdy ydl` skdb` ea d neaenpn Grdi` B àzerfanày

Sdrày`rdk jekkì 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`blì bfaydea`r `yb!+%

Irpg afy pom`by yf y`rneadk y`reke}dyefa

Sdrày`rdk y`reke}ì ou jekyrdyefa!

Ry`rek` Jekyrdyefa r`tper` d neaenpn jeky`r rdyeag fj3!? n! Yhèay`greyu fj yh` jeky`r e z`rejeì o`jfr` dai djy`r p` ou dssrfsredy`n`yhfi pbh d opook` sfeay+ iejjpefa fr sr`pr` sfeay y`y!

Afa.sdrày`rdk srfipby jfrnpkdyì ea bkfì uy`n

Irpg afy pom`by yf jekyrdyefa fr y`rneadk y`reke}dyefa

Irpg yhdy dr` srfipbì jrfn y`rek` rdw ndy`redk dai sdbldgeagbfnsfaày ea da d`syeb dr`d pai`r kfbdk Grdi` D bfaieyefa weyh dGrdi` O odblgrfpai!


12/33

_diedyefa y`reke}dyefa e pì ndeaku jfr h`dy.

àeyez` ndy`redk!

@yhukà` fxei` y`reke}dyefa e pì whà

fyh`r n`yhfi dr` afy srdbyebdok`! @zeiàb`

npy o` dzdekdok` yf hfw yh` doàb` fj dauidndgeag `jj`by fa yh` irpg whà yhe

n`yhfi e pì!

PZ rdiedyefa e afy da dbb`sydok` n`yhfi fjy`reke}dyefa!


13/33

_`bfnnàiì 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`ìì+ fs`rdyeag srfbìpr` hfpki sr`breo` eaz`yegdyefa

dai bfrr`byez` dbyefa!

Nfaeyfreag e bfaipbyì djy`r breyebdk fs`rdyefa dr` bfnsk`y`!


14/33

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


15/33

Sr`ne`=

Yf yh` sfeok` `xyày+ sr`ne` dr` iègaì yf dzfeipaa`b`dru àyru fj ps`rzefru fr bfayrfk s`rfaa`k

Yf sr`zày yh` hìieag fr dbbpnpkdyefa fj ipy daifyh`r sdryebpkdy` ndyy`r+ bèkeag+ jkffr dai wdkk ea

d`syeb dr`d+ hdz` nffyh ens`rzefp prjdb` yhdys`rney yh` r`s`dyì dsskebdyefa fj bk`daeag daiieeaj`byeag dgày!

Jdk` bèkeag dr` `dkì yf sr`zày bfaydneadyefa jrfnyh` sdb` dofz` yh`n!

Hdai wdheag jdbekeye` dr` srfzeiì faku ea bhdageagrffn


16/33

Bfayeapì!

Dbb` yf bk`da dai d`syeb dr`d e srfzeiì faku yhrfpghder kfbl!

Yh` der jfr d`syeb dr`d e psskeì yhrfpgh jeky`r fj

peydok` `jjebeàbu kel` H@SD jeky`r!

Ea breyebdk dr`d+ H@SD jeky`r hfpki o` k`dl y`yì dy k`dyyweb` d u`dr!

Sr`pr` iejj`ràyedk o`yw`à d`syeb dr`d dai dimdbàydr`d hfpki o` nfaeyfrì bfayeapfpku dai ifbpnàyì!Wdraeag uy`n hfpki dk`ry s`rfaa`k whà yh`` jdkko`kfw ydokehì keney!


17/33

@tpesnày=

@tpesnày iègaì ea pbh d wdu d yf jdbekeydy` bk`daeag+ieeaj`byefa+ fr y`reke}dyefa!

Yf yh` `xyày sfeok`+ `tpesnày jeyyeag dai `rzeb` drìègaì dai eaydkkì f yhdy fs`rdyefa+ ndeayàdab`dai r`sder bda ydl` skdb` fpyei` bk`da dai d`syeb dr`d!

Dkk `tpesnày+ eabkpieag y`reke}`r+ der.jekyrdyefa uy`n+dai wdy`r yr`dynày uy`n+ dr` pom`by yf skdaaìndeayàdab`&zdkeidyefa< yh` dssrfzdk jfr p` fj`tpesnày e ifbpnàyì!

Zày jeky`r pì fa ydyefadru `tpesnày pbh d wdy`rjfr eam`byefa (WJE% yfrdg` ydal dai j`ryeke}`r+ dain`norda` jeky`r dr` pì yf jeky`r bfnsr`ì gd`+hfpki o` eay`greyu y`yì srefr yf eaydkkdyefa dais`refiebdkku yh`r`djy`r!


18/33

Wdy`r Yr`dynày uy`n=

Wdy`r yr`dynày jdbekeye` dr` iègaì+ bfayrpbyì+dai ndeaydeaì f d yf àpr` yh` r`kedok`srfipbyefa fj wdy`r fj da dssrfsredy` tpdkeyu!

Sprejeì wdy`r e pì d j`ì wdy`r jfr WJE uy`ndai jfr bk`da y`dn gà`rdyfr! WJE e srfipbìèyh`r ou ieyekkdyefa fr ou r`z`r` fnfe!

WJE e pì ea yh` jfrnpkdyefa fj sdrày`rdk+

Erregdyefa dai eayrd fbpkdr srfipby! Sprejeì wdy`rndu o` pì ea yh` jfrnpkdyefa fj fshyhdknebsrfipby!


19/33

Bfayeapì

Dk`ry dai dbyefa keney hfpki o` `ydokehìjfr odby`redk àifyfxea dai nebrfoedk kfdi!Yh`` keney hfpki n``y dau ydaidri keyì

pai`r Rbhìpk` O yf yh` Jffi dai Irpg Dby! Ry`reke}dyefa fr r`gà`rdyefa fj wdy`r uy`n

e bdrreì fpy dbbfrieag yf d srì`y`rneaìbhìpk` dai dkf whà`z`r `ydokehìnebrfoedk bfpay dr` `xb`ìì weyhea dau fjyh` rury`nr bfnsfaày!


20/33

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 hugeà` daibk`dakea` dr` ndeaydeaì! S`refieb h`dkyhbh`bl jfr pbh bfaieyefa dr` bfaipbyì daidssrfsredy` dbyefa e ydlà!

Whà fpyei` s`rfaa`k whf hdz` afy r`bèzìpbh yrdeaeag a`ì yf o` orfpghy ea+ sdryebpkdrbdr` e ydlà weyh r`gdri yf yhèr ps`rzeefa!


21/33

Bfayeapì!!

S`rfaa`k whf hdz` o`à àgdgì ea yh` srfbèag fj daendk

yep` dr` afy dkkfwì yf ày`r dr`d wh`r` y`rek` srfipbydr` jdorebdyì pak` regfrfp dai bk`drku i`jeaìi`bfaydneadyefa srfbìpr` hdz` o`à jfkkfwì!

Fpyiffr bkfyheag e afy orfpghy eayf yh`` dr`d! S`rfaa`kày`reag yh` bhdageag rffn dr` dkr`diu bkdi ea ydaidri

srfy`byez` gdrnày iègaì jfr jdbyfru jdbekeye`! O`hdzefprdk y`bhaetp` denì dy ndeaydeaeag y`rekeyu hfpki

o` `nskfuì ou s`rfaa`k wfrleag ea d`syeb dr`d! Yh`èabkpi`

nfzeag kfwku dai i`keo`rdy`ku

l``seag àyer` 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!


22/33

Rdaeydyefa=

Wdkk+ jkffr+ bèkeag dai `tpesnày ea d`syeb dr`ddr` bk`daì dai whà r`tperì ieeaj`byì eadbbfridab` weyh d wreyyà srfbìpr`!

Ieeaj`byday dai bk`daeag dgày yf o` pì ead`syeb dr`d hfpki o` y`rek`!

Ieeaj`byday dai bk`daeag dgày dr` nfaeyfrì jfrnebrfoedk bfaydneadyefa dai dr` y`rek` whà pìea Grdi` D fr Grdi` O dr`d!

Rsfrebeidk dgày hfpki o` pì eab` ndaubfnnfa ieeaj`byday dr` ea`jj`byez` dgdeay sfr`!

Yh` bk`daeag srfbìpr` dr` zdkeidyì+ dai yhìeeaj`byefa srfbìpr` dr` nfaeyfrì!


23/33

Ndapjdbypreag bfayrfk

hyys=&&www!bfkiyr`dnkdo!bfn&endg`&jek`&kufVoeg!msg


24/33

Ndapjdbypreag bfayrfk=

Ipreag dkk srfbèag ydg`+ sr`bdpyefa dr` ydlà yf

neaene}` yh` bfaydneadyefa!

Sr`sdrdyefa bfaydeaeag kez` nebrffrgdaen dr`

aèyh`r ndi` afy yrdaj`rrì eayf bfaydea`r ea dr`d

pì jfr srfbèag fj fyh`r shdrndb`pyebdk srfipby! Yh` nfz`này fj s`rfaa`k e bfayrfkkì dai

n`yhfiebdk ea fri`r yf dzfei `xbèz` hìieag fj

sdryebk` dai frgdaen!

Dryebk` dr` y`reke}ì dai sdì eayf yh` d`syeb

dr`d ou yh` p` fj ifpokì.àiì y`reke}`r

`tpessì weyh eay`rkfbleag iffr fr ou fyh`r zdkeidyì

n`yhfi!


25/33

Wreyyà ydaidri dr` dzdekdok` s`bejueag yh` der

tpdkeyu+ eabkpieag zedok` dai afa.zedok` bfpay whebh

dr` yf o` ydlà dy k`dy fab` s`r `z`ru hejy! Yh` eay`rzdk o`yw`à bk`daeag dai y`reke}dyefa fj

bfnsfaày d w`kk d y`reke}dyefa dai p`+ e d hfry

d sfeok` dai pom`by yf yen`.keney dssrfsredy` yf yh`

zdkeidyì yfrdg` bfaieyefa

Yh` nebrfoedk bfaydneadyefa fj srfipby (oefoprià% e

neaendk srefr yf y`reke}dyefa! Yh` ndxenpn dbb`sydok`

oefoprià e `ydokehì fa d srfipby ou srfipby ode!

Yh` keney e r`kdyì yf yh` `jjebeàbu fj yh` n`yhfi yf o`

pì dai yf yh` rel fj surfgà dai odby`redk

àifyfxea+ whebh dr` afy r`nfzì ou y`reke}dyefa!


26/33

Ry`reke}dyefa fj h`dy=

Rpjjebeày yen` e dkkfwì jfr yh` whfk` kfdi yf r`dbh yh`r`tperì y`ns`rdypr` o`jfr` n`dpr`này fj yh`y`reke}eag yen` o`gea! Sr`bdpyefa dr` ydlà yf sr`zàybfaydneadyefa fj y`reke}ì kfdi ipreag bffkeag!

Ry`reke}dyefa fj nfey h`dy=

Ofyh y`ns`rdypr` dai sr`pr` bfayrfk dr` pì yfnfaeyfr yh` srfb`! Ey`n yf o` y`reke}ì+ fyh`r yhda

srfipby ea `dkì bfaydea`r dr` wrdssì+ ej a`b`dru ead ndy`redk yhdy dkkfw yh` r`nfzdk fj der dai sà`yrdyefafj y`dn!


27/33

Ry`reke}dyefa fj Iru h`dy=

Eabkpi` der berbpkdyefa weyhea yh` bhdno`r dai

ndeayàdab` fj d sfeyez` sr`pr` yf sr`zày yh`àyru fj afa.y`rek` der! Dau der dineyyì sd`yhrfpgh d H@SD jeky`r!

Ry`reke}dyefa ou rdiedyefa=_diedyefa if` e yf o` n`dprì ipreag yhey`reke}dyefa! Ifen`y`r dofroàbe` dr` r`diweyhea d s`bejeì yen` s`refi djy`r `xsfpr` yf

rdiedyefa! Ifen`y`r eaiebdyfr dr` pì yf gez` dtpdayeydyez` n`dpr`này fj if` r`bèzì ou yh`srfipby ey`kj!


28/33

Ry`reke}dyefa weyh @yhukà` fxei`=

Ier`by bfaydby fj gd dai nebrfoedk b`kk e `àyedk! 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`tperì ou yh` srfb`! Jfr `dbh

y`reke}dyefa bubk`+ r`bfri dr` ndi` fj yh` yen` ydlà yf

bfnsk`y` yh` bubk`!

Dbk`dr zepdk n`da e pì jfr iejj`ràyedyeag srfipbyyhdy hdz` afy o`à y`reke}ì jrfn yhf` yhdy hdz`

o`à y`reke}ì! Yh`` zepdk n`da dr` afy eayàiì yf

gez` da eaiebdyefa yhdy yh` kfy e y`rek`!


29/33

D`syeb jekkeag Fs`rdyefa= D wreyyà ydaidri iègaì yf y`y yh``jjebeàbu fj yh` fz`rdkk d`syeb jekkeag fs`rdyefa e ndeaydeaì!

D ndyrex dssrfdbh yf srfb` enpkdyefa ndu o` i`z`kfsì jfr`dbh jekkeag kea`+ dai hfpki eabkpi` `k`này pbh d yh` yus`fj srfipby jekkì+ ex` fj kfy+ bfaydea`r dai bkfpr`bfajegprdyefa+ jekk zfkpn`+ kea` s`ì+ jekkeag kea` bfajegprdyefadai bfnsfaày 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`rì zedk yf kufsheke}`r+ yh`kufsheke}dyefa srfb` dai yfss`reag dai brenseag fj zedk!

@z`ru s`rfa whf e afrndkku dkkfwì yf o` ea jekkeag rffnipreag d`syeb jekkeag fs`rdyefa npy sdryebesdy` ea yh` srfbènpkdyefa y`y dkfag weyh yhèr afrndk degaì ipye`!


30/33

Ry`reke}dyefa ou jekyrdyefa= Ry`reke}eag jekyrdyefa hfpki o` zdkeidyì yfr`srfipbeoku r`nfz` zedok` nebrffrgdaen jrfn yh` srfb` yr`dn+srfipbeag d y`rek` `jjkpày!

Zdkeidyefa ypie` hfpki bfaei`r jfkkfweag jdbyfr yhdy djj`by yh` jeky`rs`rjfrndab`

Zebfeyudai Rprjdb` yàefa fj yh` fkpyefa yf o` jeky`rì

sH

bfnsdyeoekeyu fj ndy`redk fr jfrnpkdyefa weyh jeky`r

sr`pr`+ jkfw rdy`

odybh zfkpn`+ ndxenpn p` yen`

y`ns`rdypr`+ fnfkdkeyu

`jj`by fj huirdpkeb hfbl

Yh` y`reke}eag jeky`r hfpki sd yh` eay`greyu y`y o`jfr` dai djy`rjekyrdyefa! Whà ywf jeky`r dr` pì+ `bfai jeky`r if` afy r`tper` sfyeay`greyu y`y pak` yh` srendru jeky`r jdek!


31/33

Okfw&jekk&`dk=

Yh`` hfpki o` y`rneadkku y`reke}ì dai eaydkkì dy

k`dy ea d Grdi` I odblgrfpai o`jfr` p`!

Efkdyfr y`bhafkfgu=

I`bfaydneadyefa srfbìpr` hfpki àpr` jpkk

`xsfpr` fj dkk efkdyfr prjdb` yf yh` bh`nebdk dgày!

D or`dbh fj efkdyfr eay`greyu hfpki afrndkku k`di yf d

i`bfaydneadyefa bubk`! Eay`greyu bda o` djj`byì ousfw`r jdekpr`+ zdkz` jdekpr`+ hfk` ea gkfz` dai

`dn+ eadi`tpdy` fz`rsr`pr`!


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Tpdkeyu bfayrfk=

Jekkì bfaydea`r fj sdrày`rdk srfipby dr` eas`byìeaiezeipdkku jfr yh` sr`àb` fj sdryebpkdy` dai fyh`ri`j`by! Eas`byefa e ifa` pai`r ekkpneadyefaodblgrfpai ea peydok` dai bfayrfkkì bfaieyefa!

Fs`rdyfr ifeag yh` eas`byefa sd r`gpkdr ù` eghybh`bl!

Jekkì dnspk` dr` pom`by yf d K`dl`r Y`y (Iuènn`refa y`y% yf bh`bl yh` eay`greyu fj yh` `dk daindeayàdab` fj zdbppn wh`r` dsskebdok`!

@dbh y`reke}`r kfdi e yr`dyì d d `sdrdy` odybh jfry`rekeyu y`yeag sprsf`! Odybh` jdekeag da eaeyedky`rekeyu y`yeag dr` r`m`byì pak` d yhfrfpgheaz`yegdyefa e bdrreì fpy dai eaeyedk y`y e eazdkeidyì!


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cGMP regulations of Sterile Products