Phamacuical Quality Aouran BP606T

ervedt
Dr. Parjanya Shuhla
&
ub par Records andRebort Dr. M. P. Singh lassea

Reborhng d Non-Clinical LaboraderyStudyRorul

A inal epot ahal bi praparedor och non-cuinicad
JaboraroryU study and shal iudi -
Nom nd addrew Ke study faubky
7 and dat o
study initatd and comhufid.
Objeckves and proudurus sBakad in abbrovsd þrotocal.

Stobishcal mehods employd gor analysing daha.

The tesB and comrol ovhcles idenhiad by namu, cods

numbr, sangtR purily and combosion or otRer
choraderishics
&tability of test and comtrol ovhcles.

A A doncnpkon d mahods usd.

A A decnphon K tut bystem uusd.

A ducrphon t do>age, doxaq egimen , Rout

adminishraffon and durahbn
Th homu od Ke Atudy diractor, ok1r scienist»,
supIrvisoy AYAOnn mvolvad in Ki kBudy.

A ducnphion o tku tronslomahons, cal uwahona, o

opAYahions arformud on i daa, a kummory and onalysis
d' h dato andand slalement o com dusions drdwn rom thi
analysix
 Th Jocatons w huu all Abiumuns, xaw data,
and inal aport 0ra to b Atorad. Dr. Parjanya Shukla

Dr. M.P. Stngh laee

> Tk statamant praporad and signud by lualiky AMuanu unit.
Th inal vaport shall ba aignud and datad by Ka
study d're ctor.
ConechoDs 07 addiHons t h inal xepat shall bi
n Keom an Amenodmen by otudy di'richr.

toraqL and Refrieval u tordk and data

AU rauw daka, doumuntabon, prototol, inal port
and spe i muns

must b indsxad and utasned in an

archive
Thuw shall b orchi vs for ordorly Atorage.
An individual ahall bs
idunijind as baing suponaible
oY K archivts

Onby auhoiaed pATAOnn

Only may entar Ki orchiva .
Reban kon Records
www w

Th documuntahon corda, daa and

cuinical
Xao
sptumuns a
non-
Jaborakony study
shal ba ufhinnd foT o bariod al uastyk0TA (folowoing
tK da'e approval by FDA
fOr InvLAhgahonal Nuw Drug Applbeakiona or (IND») 5
Jhvigdhiona odviu exembHons (1DE») ys0YA