good laboratory practice 1205217721934254 4

7/24/2019 Good Laboratory Practice 1205217721934254 4

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GOOD LABORATORY PRACTICE


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Do, what you write

Write, what you do


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GLP goes hand-in-hand

with A !"ua#ity assuran$e%

GLP without "ua#ity isuse#ess


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&'A( )EDERAL DR&G AD*I+I'TRATIO+

./( )ood, Drug and Cos0eti$ A$t )DA has

to 1ro2e the 1oor "ua#ity 3or withdrawing a

drug 3ro0 the 0ar4et

56( *anu3a$turer has to e33e$ti2eness o3 a

drug

/7( *anu3a$turer has to 1ro2e sa3ety

and e33e$ti2eness o3 8+ew Drugs9


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&'A

)EDERAL DR&G AD*I+I'TRATIO+

:(

Good La;oratory Pra$ti$e Regu#ations

!Re2ised se2era# ti0es%

Other agen$ies had endorsed the $on$e1t

Eg( En2iron0enta# Prote$tion Agen$y !EPA%


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GLP is not an

A$t


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Code o3 )edera# regu#ations

!)ood and Drug Ad0inistration%Part =6

Good La;oratory

1ra$ti$e 3or non-$#ini$a#


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Organisation 3or E$ono0i$ Co-o1eration

and De2e#o10ent !OECD%

:

Prin$i1#es o3 Good La;oratory Pra$ti$e

O;>e$ti2e

To 1ro0ote the "ua#ity and 2a#idity o3 test

data used 3or deter0ining the sa3ety o3$he0i$a#s and $he0i$a# 1rodu$ts


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'$o1e

Industria# $he0i$a#s Phar0a$euti$a#s

?eterinary drugs

Pesti$ides, Cos0eti$s

)ood additi2es

1reser2ati2es Basi$ Resear$h


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What GLP is not

E@$e##en$e o3 a #a;oratory

ua#ity o3 an organisation

ua#ity o3 a 1rodu$t

Pro3essiona# $o01eten$e


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Then, what is GLP

GLP indi$ates "ua#ityo3 a study


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De3inition

Good La;oratory Pra$ti$e is a "ua#itysyste0 $on$erned with the organisationa#

1ro$ess and the $onditions under whi$h

non-$#ini$a# hea#th and en2iron0enta#sa3ety studies are 1#anned, 1er3or0ed,

0onitored, re$orded, ar$hi2ed and

re1orted!OECD, :%


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A$$e1ta;i#ity

Credi;i#ity


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Do not assu0e anything

Good s$ien$e Co01#ian$e


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Do not in2ent good 1ra$ti$e

Co01#ian$e with nationa# #egis#ation

Co01#ian$e with nationa# standard

Co01#ian$e with internationa#

standards?a#idation o3 own standards


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Ter0ino#ogy

ua#ity 'yste0

ua#ity and Re"uire0ent

Ca#i;ration and Tra$ea;i#ity

'tandard

Re3eren$e *ateria#

'tandardisation


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*a>or Co01onentsCreation o3 AC &ALITY A''&RA+CE &+IT

A11oint0ent o3 a 'T&DY DIRECTOR

+eed 3or written 1roto$o#s 'OPs

'TA+DARD OPERATI+G PROCED&RE'

Necessity for using STANDARDISED, CALIBRATED and

MAINTAINED equipmentinstrument

Co!!ection and ana!ysis of data "y #$ALI%IED &ERS'NS


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AC

A "ua#ity 1o#i$yA "ua#ity 0anua#

Contro# o2er a## do$u0entsua#ity at0os1here

We## dra3ted 81#an o3 a$tion9


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'tudy Dire$tor

Res1onsi;#e 3or the study

as $ontro# o2er e2erything

*ay ha2e a 8Prin$i1a#in2estigator9


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A written 1ro$edure 3or

doing e2erything

'OPWor4 instru$tion

Wor4 1ro$edurewor4 1roto$o#


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)a$i#ity

E"ui10ent

En2iron0ent

Raw 0ateria#s

*aintenan$e


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Peo1#e 1ro;#e0s

&ns$ienti3i$

&ntrained

&naware

&nhe#13u#


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GLP in a$tion-I

A2ai#a;i#ity o3 written do$u0entsA p!ace for e(eryt)ing and e(eryt)ing )as a p!ace

Assessing qua!ity of ra* materia!s

Maintenance of equipment

&urc)ase of ra* materia!sAut)orisation to do recei(e, )and!e test materia!s

En(ironmenta! monitoring

Disposa! of *aste


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GLP in a$tion-II

A2ai#a;i#ity o3 written do$u0entsEntry restrictions

Ensuring safety

Aut)orisation to do recei(e, )and!e test materia!s

Descri"ing qua!ificationtraining requirements of staffTraining of ne* personne!


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GLP in a$tion-III

A2ai#a;i#ity o3 written 1ro$edures


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GLP in a$tion-I?

Do$u0entation in a11ro2ed 3or0atsLog "oo. for equipment

Data s)eets for recording data

Records of receipt, test procedures

Appro(ed report formats

Compi!ation of data


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GLP in a$tion-?

Regu#ar "ua#ity $he$4sAuditing "y qua!ified auditors

Regu!ar reporting of NCs andor NICs

&re(enti(e and correcti(e actions


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GLP in a$tion-?I

*anage0ent $o00it0ent%or ensuring )ig) professiona! standards

%or up dating procedures according to

c)anges in standards

&articipation in inter/!a"oratory comparisons

&articipation in proficiency testing


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GLP in a$tion-?II

'tudy0e!! defined study p!an

0e!! defined protoco!s

Identification of critica! stages

Assured performance

Reporting of de(iations

Compi!ation of data "y qua!ified personne!s

Interpretation of data "y professiona!s

Arc)i(ing of materia!sdataresu!ts


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An auditors 2iew

What was the tas4Why 1er3or0 the tas4Who 1er3or0ed the tas4When was it doneow was it re$orded

Summary


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P#anned 'tudy

ua#ity Per3or0an$e

Rigorous *onitoring

&na0;iguous Re$ords

'tudy Dire$tor9s Re1ort

Ar$hi2ing o3 0ateria#s

y

A d 3 GLP


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Are we ready 3or GLP

We are ready, when we write what we do and when we

do what we write, o3 $ourse in $o01#ian$e with

nationa#

good laboratory practice 1205217721934254 4

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