Phamauuhical Quualiy Anuronu

w P604T
Good Laborabryock Dr. Paryanya Shukta
&
TKto1mal agulaory Conupt oGood LaboYaBoy pr..2. StnghClosu
PraH" (GLP)onig 'n atsd in USA in 1976

du to tKe conurn abou vali diy non- clinical sofaky

dado submitlad to food and Drug AdminishaHon (fDA)
in cmoxt to Nuo Drug Applic dkons (NDA)

FDA published proporad Rgqulaions oN CLP in 1976

wih extabLshmenl ofdinal Rul in Jun 1979 (a1 CER58)

DeiniHon
w
ood Laboraoy Prach i dadined as

a 9ualiy Aystem conurnid oih Hiorgoni 3ahonal proas

and K dobity under which non- cliical kalh and
eDviron mental safety studiss o
plonnad, parfovmud, monitorad, xucord1d, ochind and
suportad.

x Th teym GLP is most commonly anouated wih Ki

phomowukeal industy
1ovids Jugured non-cluinical animal teshing hal must bs
ArOYmad prioT to apbroval of N rug poduc

Tinupus ood LaboraBory Araviu -

i s t o promota tKo devalopment o quality test data and

provid a tool to enauT a hound opþroach to HKe
managamanf of Laboradory studbius, in dud'ng conduct , xepoxing and
grchiving
 conaiderad
Thi prinuiplas may as
Dr. Paryana Shuda

a esat standardsoT 2nsuming qualh quall b Dr.M.9.Stngh Aoe

voriabl
uliabilhy and mtuqriky of studias, Ke xaporhng od
Com clusions androcaaibilty of daBa.
T prinup suquu'rs insituhon
to amign au and dusponsibiuiy to sBah to ensure
Goodob»envahion mangemtn oach Btudy
Th pharmouukcal davtlopmunt K GLP prinupl

apphs ony o study whith are non-cdinital

Thi GLP equiremunh for non- dlinical Jaboraoy studies
Conductad to evaluat drugAaftky CovAY Kollowtnq
Clanes oSkudies-
ing doss toxiuky.
Ropabad doss toxis ky.
Raproduchiv toxiu'by
Mutagenic potankial.
Cortinogenic botenhial
TOxitoXinshts
Phamacodynemic studis duignud to tast pokanHal
or adverAA ocds
Loca toleronu &tudits phototoxiety.
itaton
Sonaikigahon studius
 ubbort A General ovisions
-

Dr. Parlanya Shutla

Dr. M. P. 8tngh Clas

Prochu sbould be applizd to

x Cood LaboraBo
non-cinicol sofaty toshng
cosmehc produca,
in phamauwhtal produtts, þoshsde þroduch,
Voterinary druqs as wi as ood addiH ves eed
additas and in dushialchsmicals.

Thus tast itams au mostly Ayntkahic chemicals Kaving

natural or biologica onain o7 ving ivin
org onism
T h mpose o tosking i to get daBa on tKeir popaxhas
and Reir ofekywih pecd to human
humon huallh.

Objachves o LP-
)aLP rovides Ki daro submited o7 Octuraks

rom uAlh obtained dunng Ki study.

) Doto obteuind or trauabl.
Thiais an intarnahionad acaptanu otes.

Deinikonsne(Thludus de/iniltons terms Kaving

Tsokch Maonp any food
speujic mcanv'ng)
oddikva, calo.ur addikve ,
bioJogiraproducd, bphamawuhcal produe.,
madica deviu et.

3
Non- clinical Laboraoyy study
Dr. Paraya Shua
muans any in-vivo 0T in. mtro 2xpirimint r. M.. Stngh Gosee
in which orhe is studiud in a test syskem

under Jabovaty comdihions to datarmin1 ih afuky.

By-On. Mahundia halapSingh