GCLP Introduction - daids crss
GCLP Introduction - daids crss
GCLP Introduction - daids crss
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TdæanGnuvtþmnÞIrBiesaFn_Büa)all¥ (<strong>GCLP</strong>)<br />
Rkumh‘unplwt»sf Inc ©2008, rkSasiTRKb;y:ag<br />
karbkRsay 5.0, 15 kkáda 08<br />
karKaMRTrbs;RksYg DAIDS<br />
karBinitükEnøgmnÞIrBüa)al<br />
- karvaytMélkarRsavRCavmnÞIrBüa)all¥<br />
- karGnuelameTAtamc,ab;TMlab;nana<br />
- karGnuvtþBiFIkarRtwmRtUv<br />
- karFanara:b:rgKuNPaB<br />
DAIDS<br />
Upcoming DRTE<br />
PPD<br />
(GñkTTYlkic©snüa)<br />
karKaMRTkarRsavRCav<br />
mnÞIrBüa)al<br />
- TIkEnøg/ BiFIkarCak;lak;/ nigesvakmμsMPar³ eTAkan;<br />
shKmn_RsavRCavmnÞIrBüa)al DAIDS<br />
- karKaMRTdl;karsikSamnÞIrBüa)alEdlCabNþaj<br />
nigminEmnCabNþaj
sMeNIr¼B½t’manBIkarhwVkhVWn<br />
www.<strong>daids</strong>crs.com<br />
jason.ezzelle@wilm.ppdi.com<br />
tiri.towindo@europe.ppdi.com<br />
michael.stirewalt@wilm.ppdi.com<br />
ehtuGVI)anCaeyIgbegáItnUvkmμviFIenHeT,Ig?<br />
mansMeNIrCaeRcInBIsmaCikbuKÁlikmnÞIrBiesaFn_enAtamTIkEnøgnimYy²<br />
kgVHxatnUvbTdæannanarbs;rdæaPi)al EdlGnuvtþkargarRsavRCavmnÞIrBiesaFn_Büa)al<br />
bBaðananaEdl)anekIteLIgBIGtItkaledaysarkarsakl,g<br />
lTplénkareFVIsvnkmμCab;lab;<br />
ehtuGVI)anCa NIH<br />
pþl; pþl; fvikardl;<br />
kEnøgnana?<br />
karhwVkhVWnmnÞIrBiesaFn_tamtMrUvkarCak;Esþg<br />
etI <strong>GCLP</strong><br />
CaGVI?
TbBa¢aepSg²<br />
kgVHxatnUvkarGnuvtþn_tambTdæan¼bTbBa¢arbs;rdæaPi)al<br />
OECD<br />
GLP?<br />
SANAS?<br />
GLP – munmnÞIrBüa)al<br />
CLIA – KμankarsikSaRsavRCav<br />
eKalkarN_epSg²<br />
CLSI?<br />
CAP?<br />
ISO?<br />
karhwVkhVWnmnÞIrBiesaFn_tamtMrUvkarCak;Esþg<br />
• karGnuvtþn_mnIÞrBiesaFn_EdlminsIusgVak;Kña GacQaneTAdl;karsMrbsMrYl<br />
cMeBaHTinñn½yénkarsikSa.<br />
• karerobcMTinñn½y hak;dUcCaminGaceRbI)an edaysarbBaðaepSg²énlTæpl<br />
mnÞIrBiesaFn_.
]TahrN_Cak;EsþgepSg²<br />
PaBminRsbKñaéntMélkMrwtfñaM<br />
x
TaMgenH KWedayehtuGVI ……<br />
• karbgðaj]beTsbeRgon<br />
• TisedA¼eKalbMNgnana<br />
• skmμPaBepSg² nigkarBiPakSa<br />
enHKW edayrebobNa ……<br />
viFIsaRsþsikçasala<br />
emeronsMrab;beRgon<br />
• karGnuvtþmnÞIrBiesaFn_Büa)all¥ (<strong>GCLP</strong>)<br />
• GgÁkar nigbuKÁlik<br />
• mnÞIrmnÞIrBiesaFn_ nig sMPar³<br />
• kMNt;Rta nigr)aykarN_epSg²<br />
• sMPar³sMrab;eFVIetsþ nigkarRbtibtþi
emeronsMrab;beRgon<br />
• karRKb;RKgsMNak nigtamdansMNak<br />
• karepÞógpÞat;bBa¢ak; énkarRbtibtþic,as;las;<br />
• suvtßiPaBmnÞIrBiesaFn_<br />
• RbB½nTinñn½ymnÞIrBiesaFn_<br />
• RbB½nRtYtBinitüRKb;RKgKuNPaB<br />
kUnesovePAbTbBa¢a<br />
GLP, CLIA nigkMNt;Rta<br />
eGT,icRtUnicepSg²<br />
sMPar³ÉksareyagepSg²<br />
ÉksaremeronbeRgon<br />
sMPar³sikçasala<br />
TRIVA!!!!<br />
RTg;RTayKYreGaycUlcitþ…..<br />
eGayeQμaH):ar:asIutfa “ekasikartUc²”<br />
nigmanCaeRcInmuxeTot!
etI eyIg TTYleCaKC½yedayrebobNa?<br />
eyIg RtUvEtskmμ …<br />
eyIg minRtUveKgeT …<br />
eFVIkarCaRkum KwCakarcaM)ac;<br />
kargarCaRkum<br />
eyIg RtUvsYrsMnYr …<br />
“kargarCaRkum KWmansar³sMxan;Nas; ehIyvaesÞIrEtminGacman<br />
lTPaBQaneTAdl;kMBUlénsmtßPaBrbs;Gñk b¤ minGacsMerc<br />
)annUveKaledATaMgLayEdlGñkcg;)anenaHeT RbsinebIGñkmin<br />
BUEkkñúgkargarCaRkumeTenaH” Brian Tracy
karGnuvtþmnÞIrBiesaFn_l¥<br />
21 CFR Epñk 58<br />
RbvtþiénkarGnuvtþmnÞIrBiesaFn_l¥<br />
RksYgcMNIGahar nig»sf )aneFVIsvnkmμmnÞIrBiesaFn_enH<br />
EdlCaEpñkmYyénkarEkERbc,ab;»sffμI énqñaM1962.<br />
Gs;ry³eBlCit 20 qñaM (1950 – 1970),<br />
mnÞIrBiesaFn_mYy)anRbtibtþikargarRbEhl 40%<br />
énkareFVIetsþCatiBulviTüa enAkñúgshrdæTaMgmUl<br />
B½t’manEdl)ancat;TukCaemaX³<br />
70% énTinñn½yRtUv)ankMNt;faCaemaX³<br />
edaysarPaBxusEbøkKñarvagkareFVIkarsikSa<br />
nigTinñn½ymnÞIrBiesaFn_<br />
cat;TukCaemaX³<br />
Data from guest essay by Dr. Janine Denis Cook, Ph.D. on Westgard QC website (www.westgard.com)
B½t’manEdl)ancat;TukCaemaX³<br />
edaysarPaBxusEbøkKñaTaMgenaH/ FDA )andak;kMriteGayerobrynUv<br />
kareFVIetsþmnÞIrBiesaFn_<br />
- 1976 -<br />
eKalkarN_ GLP<br />
)anesñIeT,Ig<br />
- 1978 -<br />
eKalkarN_<br />
GLP)anRtUvbBa¢b;<br />
- 1979 -<br />
eKalkarN_ GLP<br />
manRbsiT § PaB<br />
- 1987 -<br />
eKalkarN_ GLP<br />
)anEkERb<br />
karGnuvtþmnÞIrBiesaFn_l¥ (GLP)<br />
TisedAén GLP KWedIm,ICYyeGaysMerc)annUvlTplepSg² Edl³<br />
EdlGacKYreGayTukcitþ)an<br />
EdlGaceFVIeT,Igvij)an<br />
EdlGaceFVIsvnkmμ)an<br />
EdlGacTTYlsÁal;)an<br />
karGnuvtþmnÞIrBiesaFn_l¥ (GLP)<br />
vaCYyFanam©as;CMnYy]btßmÖTaMgT,ay nigGaCJaFrfaTinñn½y EdlbBa¢Ún<br />
mk³<br />
KWBitR)akdCakarqøúHbBa©aMgnUvlTplnana Edl)anTTYlkñúg<br />
kMT,úgeBlsikSa<br />
GacBwgGaRs½y)an enAeBlEdleFVIkar)a:n;RbmaNsuvtßiPaB<br />
nigPaBEdlGacmaneRKaHfñak; b¤PaBRbfuyRbfan
karGnuvtþmnÞIrBiesaFn_l¥ (GLP)<br />
EbgEckeTACa 9 Epñk³<br />
1. xEcgTUeTA<br />
2. GgÁkar nigbuKÁlik<br />
3. TIkEnøgBiesaFn¾<br />
4. sMPar³<br />
5. karRbtibtþi ]brkN_eFVIetsþ<br />
6. maRtaénkarRKb;RKg nigeFVIetsþ<br />
7. eFVIkarsikSaeTAelImnÞIrBiesaFn’minBüa)al<br />
8. kMNt;Rta nigr)aykarN_epSg²<br />
9. karminTTYlsÁal;énkEnøgeFVIetsþBiesaFn_ b¤ dksiTi<br />
EpñktUc²én GLP<br />
A. xEcgTUeTA<br />
pþl;nUvB½t’manTUeTA dUcCaTMhM niymn½y lTPaBénkarsikSa Edl)anRbtibtþi<br />
enAeRkamCMnYy nigkic©snüanana nigkareFVIGFikarkic©cMeBaH]bkrN_nana<br />
§58.1, 58.3, 58.10, 58.15<br />
B. GgÁkar nigbuKÁlik<br />
rcnasm
EpñktUc²én GLP<br />
K. karminTTYlsÁal;nUvmnÞIrBiesaFn_<br />
eKalbMNgénkarminTTYlsÁal;nUvmnÞIrBiesaFn_ b¤ dksiTiKW³<br />
– dkecjnUvTIkEnøgBiesaFn_eFVIetsþNa Edlxkxanmin)anGnuelam eTAtam<br />
GLP rhUtTal;EtGacbgðajRKb;RKan;fa karminGnuelam eTAtamenaH<br />
minekIteT,IgeTotkñúgkMT,úgeBl b¤minb:HBal;dl;suBlPaB b¤ PaBEdlGac<br />
TTYl)anénTinñn½yEdl)aneFVIeT,Ig tamkarsikSaCak; lak;NamYy<br />
– dkecjBIkarBicarNanUvral;karsikSaEdl)aneFVIcb;sBVRKb;bnÞab;BIéfEdldk<br />
siTi luHRtaEtmnÞIrBiesaFn_enaHeGacbMeBjlkçNtamrbs;KN³kmμaFikarfa<br />
xøÜnnwgeFVIkarsikSanana edayGnuelameTAtam bTbBa©aTaMgenaH<br />
sMNYr?<br />
ehtuGVI)anCa eyIg RtUvkar<br />
karGnuvtþn_CamnÞIrBiesaFn_l¥?<br />
karGnuvtþn_sñÚl<br />
eyIgRtUvmankarGnuvtþn_sñÚlCak;lak;nana edIm,Ipþl;nUvTinñn½y<br />
Edl³<br />
GacTukcitþ)an<br />
GaceFVIeT,Ig<br />
vij)an<br />
GaceFVIsvnkmμ<br />
)an GacTTYlsÁal;)an
TbBa¢ananaén GLP<br />
bTbBa¢ananaén GLP / dUcEdlmansresr/ pþl;nUvsMeNIrmYycMnYnsMrab;<br />
eGayGnuvtþtam.<br />
EteTaHCay:agNak_eday/ manbTbBa¢aepSg²CaeRcIneTot EdlRbhak;RbEhl<br />
nwg GLP Edr Edl)aneRbIR)as;edaymnÞIrBiesaFn_Büa)almYycMnYn.<br />
c,ab;énkarEkERbedIm,IeFVIeGayRbesIreT,Igdl;mnÞIrBiesaFn_Büa)al<br />
qñaM 88<br />
bTbBa¢aTaMg<br />
enaHGacman<br />
enAkñúg: 42<br />
CFR Part<br />
493<br />
1967<br />
CLIA<br />
)ankarGnum½t<br />
1987<br />
)anpSBVpSayenA<br />
kñúgsarB½t’man<br />
RtUv)ansÁal;faCa³<br />
karEkERbc,ab;edIm,I<br />
eFVIeGayRbesIreT,Igdl;<br />
mnÞIrBiesaFn_Büa)al<br />
qñaM 1988<br />
Rbvtþi CLIA<br />
Extula, 1988<br />
sPa)anGnum½t<br />
CLIA<br />
ExkumÖ³ TI<br />
28,1992<br />
)ane)aHBumÖnUvkar<br />
cuHeQμaHcugeRkay<br />
ExkBaØa TI 1,<br />
1992<br />
karGnuvtþn_<br />
b¤CasamBaØehAfa<br />
CLIA<br />
Exmina, 1995<br />
)ane)aHBumÖnUveKal<br />
karN_karcuHeQμaH<br />
sMrab; PPM
)ane)aHbg;<br />
bdiesF<br />
segçbxøI²én CLIA<br />
sMrbsMrYl<br />
enAkNþal<br />
(PPM)<br />
x
segçbxøI²én ISO<br />
GgÁkarGnþr³CatisMrab;kMNt;bTdæan<br />
karkMNt;bTdæanGnþrCati )ancab;epþImeT,IgCamYynwgvis½yEpñk<br />
bec©keTs (IEC)<br />
)anbegáItenAqñaM 1906<br />
karepþatCasMxan; KWeTAelIvisVkmμemkanic<br />
ISO )ancab;epþImRbtibtþikarenAqñaM 1947<br />
segçbxøI²én ISO<br />
GgÁkarGnþr³CatisMrab;kMNt;bTdæan<br />
1977 – snñisiTGnþrCatielIkTI1sþIGMBIkarTTYlsÁal;KuNPaBmnÞIr<br />
esaFn_ (ILAC) )anR)arB § eFIVeT,Ig<br />
1982 -ISO nig IEC (CamYytMNagrbs;shrdæGaemrik) )anplit<br />
rYmKñanUvÉksarmYy/Edlcat;taMgCa ISO/IECesovePAmKÁúeTsn_ 25-1982<br />
esovePAmKÁúeTsn_ ISO/IEC 25-1982.<br />
" tMrUvkarTUeTAénsmtßPaBénmnÞIrBiesaFn_eFVIetsþnana "<br />
segçbxøI²én ISO<br />
GgÁkarGnþr³CatisMrab;kMNt;bTdæan<br />
)aneFVIeGayTan;sm½y enAkñúgqñaM1990 edIm,I;<br />
“tMrUvkarTUeTAénsmtßPaB énsarCatimanRbtikmμ nigkareFVIetsþ<br />
mnÞIrBiesaFn_".<br />
esovePAmKÁúeTsn_ ISO/IEC 25 )ankøayCa ISO/IEC 17025<br />
kñúgqñaM 1999<br />
ISO/IEC 17025 nig 15189 – bTdæansMxan;² Edl)aneRbI<br />
edaymnÞIrBiesaFn_eFVIetsþ nigmnÞIrBiesaFn_sarFatueFVIeGaymanRbtikmμ
Pñak;garTTYlsÁal;nana<br />
• bEnßmBIelI GLP nig CLIA, enAmanPñak;garTTYlsÁal;xus²<br />
KñaCaeRcIneTot<br />
• ]TahrN_ rYmman³<br />
saklviTüal½yeraKsaRsþGaemrikaMg (US)<br />
RbB½n § TTYlsÁal;CapøÚvkarCatiGaRhVikxagt,Úg (SA)<br />
karTTYlsÁal;mnÞIrBüa)alCMgW (UK)<br />
smaKmCatiénGaCJaFreFIVetsþ (Australia)<br />
karbegáItkmμviFI<br />
• GLP, CLIA, ISO, CLSI, KN³kmμkarTTYlsÁal;nUvKuNsm,tþiCapøÚvkar .l.<br />
eyIgehAvafa kareFVIeGayRbesIreT,Ig …<br />
Éksareyag<br />
• karsakl,gePJóv³ karGnuvtþmnÞIrBiesaFn_l¥ nig CLIA: JD Cook<br />
(Guest Essay: Good Laboratory practice (<strong>GCLP</strong>) versus<br />
CLIA: JD Cook)<br />
• 42 CFR 493<br />
• 21 CFR 58
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