Draft of GLP Inspection Checklist

Name of the Company Address of the Company Contact Person Type of Inspection Date(s) of Inspection Name of the Inspector 12345!S.No.

"i#nat$re of the Inspector

Principles of Good Laboratory Practice !"S! #$CILI!Y %RG$NI&$!I%N $ND P"RS%NN"L Test Facility Managements Responsibilities Does the Test &aci'ity (ana#ement ens$re that Princip'es of )ood *a+oratory Practice are comp'ied ,ith- in its test faci'ity. Does a statement e/ist to identify the indi0id$a'(s) ,ithin a test faci'ity ,ho f$'fi' the responsi+i'ities of mana#ement as defined +y these Princip'es of )ood *a+oratory Practice. Are there a s$fficient n$m+er of 1$a'ified personne'appropriate faci'itiese2$ipment- and materia's A0ai'a+'e for the time'y and proper cond$ct Does the mana#ement maintain proper record of the 2$a'ifications- trainin#- e/perience and 3o+ description for each professiona' and technica' indi0id$a'.

Yes / No

Comments/Remarks

. 1.1 1%1%1

1%1%2 (a) (+)

(c)

(d)

(e)

Does the mana#ement ens$re that personne' c'ear'y $nderstand the f$nctions they are to perform and,here necessary- pro0ide trainin# for these f$nctions. (i) Are appropriate and technica''y 0a'id "tandard 4peratin# Proced$res ("4Ps) esta+'ished and fo''o,ed. (ii) Does the mana#ement appro0e a'' the ori#ina' and re0ised "4Ps. Is there a 1$a'ity Ass$rance Pro#ramme ,ith desi#nated personne'. Does the mana#ement ass$re that the 2$a'ity ass$rance responsi+i'ity is +ein# performed in accordance ,ith Princip'es of )*P. Does the mana#ement ens$re that for each st$dy- an indi0id$a' ,ith the appropriate 2$a'ifications- trainin#and e/perience is appointed as "t$dy Director +efore the initiation of the st$dy. Does a proced$re e/ist for rep'acement of a "t$dy Director and is this proced$re doc$mented. Does the mana#ement ens$re that in the e0ent of a m$'ti-site st$dy- if needed- a Principa' In0esti#ator is desi#nated ,ho is appropriate'y trained- 2$a'ified and e/perienced to s$per0ise the de'e#ated phase(s) of the st$dy. Does a proced$re e/ist for rep'acement of a Principa' In0esti#ator and is this proced$re doc$mented.

(f)

(i) (ii)

(#)

(i)

(ii) (h) (i)

(ii)

(i)

Does the mana#ement ens$re that there is a doc$mented appro0a' of the st$dy p'an +y the "t$dy Director. Does the mana#ement ens$re that the "t$dy Director ma5es the appro0ed st$dy p'an a0ai'a+'e to the 1$a'ity Ass$rance personne'. Does the mana#ement ens$re the maintenance of a historica' fi'e of a'' "4Ps.

(3)

(5)

(')

Does the mana#ement ens$re that an indi0id$a' is identified as responsi+'e for the mana#ement of the archi0e(s). Does the mana#ement ens$re that a master sched$'e is maintained. Does the mana#ement ens$re that test faci'ity s$pp'ies meet re2$irements appropriate to their $se in a st$dy. Does the mana#ement ens$re that for a m$'ti-site st$dy- c'ear 'ines of comm$nication e/ist +et,een the "t$dy Director- Principa' In0esti#ator(s)- the 1$a'ity Ass$rance Pro#ramme(s) and st$dy personne'. Does the mana#ement ens$re that test and reference items are appropriate'y characteri6ed. 7as the mana#ement esta+'ished proced$res to ens$re that comp$teri6ed systems are s$ita+'e for their intended p$rpose- and are 0a'idated- operated and maintained in accordance ,ith the Princip'es of )ood *a+oratory Practice. 8hen a phase(s) of a st$dy is cond$cted at a test site- does the test site mana#ement ha0e the responsi+i'ies as defined a+o0e- ,ith the e/ceptions of 1%1%2(#)- (I)- (3) and (o). Study Directors Responsibilities Does the "t$dy Director appro0e the st$dy p'an and any amendments to the p'an +y dated si#nat$re. Does the "t$dy Director ens$re that the 1$a'ity Ass$rance personne' ha0e a copy of the st$dy p'an and any amendments in a time'y manner. (ii) Does the "t$dy Director comm$nicate effecti0e'y ,ith the 1$a'ity Ass$rance personne' as re2$ired d$rin# the cond$ct of the st$dy. Does the "t$dy Director ens$re that st$dy p'ans and amendments and "4P9s are a0ai'a+'e to st$dy personne'. Does the "t$dy Director ens$re that the st$dy p'an and the fina' report for a m$'ti-st$dy identify and define the ro'e of any Principa' In0esti#ator(s) and any test faci'ities and test sites in0o'0ed in the cond$ct of the st$dy. (i)

(m) (n)

(o)

(p) (2)

1%1%3

1.2 1%2%2 (a) (+)

(c)

(d)

(e)

(i) (ii)

Does the "t$dy Director ens$re that the proced$res specified in the st$dy p'an are fo''o,ed. Does the "t$dy Director assess and doc$ment the impact of any de0iations from the st$dy p'an on the 2$a'ity and inte#rity of the st$dy- and ta5e appropriate correcti0e action if necessary.

(f) (#) (h)

(i)

1.3 1%3%1

Does the "t$dy Director ac5no,'ed#e de0iations from the "4P9s d$rin# the cond$ct of the st$dy. Does the "t$dy Director ens$re that a'' ra, data #enerated are f$''y doc$mented and recorded. Does the "t$dy Director ens$re that comp$teri6ed systems $sed in the st$dy ha0e +een 0a'idated. Does the "t$dy Director si#n and date the fina' report to indicate acceptance of responsi+i'ity for the 0a'idity of the data and to indicate the e/tent to ,hich the st$dy comp'ies ,ith the Princip'es of )ood *a+oratory Practice. Does the "t$dy Director ens$re that after comp'etion (inc'$din# termination) of the st$dy- the st$dy p'an- the fina' report- ra, data and s$pportin# materia' are archi0ed. Principal In estigators Responsibilities Does the Principa' In0esti#ator ens$re that the de'e#ated phases of the st$dy are cond$cted in accordance ,ith the app'ica+'e Princip'es of )ood *a+oratory Practice. Study Personnels Responsibilities Are a'' personne' in0o'0ed in the cond$ct of the st$dy 5no,'ed#ea+'e in those parts of the Princip'es of )ood *a+oratory Practice- ,hich are app'ica+'e to their in0o'0ement in the st$dy. (i) Do the "t$dy Personne' ha0e access to the st$dy p'an and appropriate "4P9s app'ica+'e to their in0o'0ement in the st$dy. (ii) Do they comp'y ,ith the instr$ctions #i0en in these doc$ments.

(iii)

1.! 1%4%1

1%4%2

(iii)

1%4%3

(i)

(ii) 1%4%4 (i)

Do they doc$ment and comm$nicate a'' de0iations from these instr$ctions direct'y to the st$dy director- and:or if appropriatethe Principa' In0esti#ator. Do the "t$dy Personne' record ra, data prompt'y and acc$rate'y and in comp'iance ,ith the Princip'es of )ood *a+oratory Practice. Are they responsi+'e for the 2$a'ity of their data. Do the "t$dy Personne' e/ercise hea'th preca$tions to minimi6e ris5 to themse'0es and to ens$re the inte#rity of the st$dy. Do they comm$nicate to the appropriate person any re'e0ant 5no,n hea'th or medica' condition in order that they can +e e/c'$ded from operations that may affect the st$dy.

(ii)

' 2.1 2%1%1

()$LI!Y $SS)R$NC" PR%GR$**" "eneral Does a doc$mented 1$a'ity Ass$rance Pro#ramme e/ist in the test faci'ity to ens$re that st$dies performed are in comp'iance ,ith the Princip'es of )ood *a+oratory Practice. Is the 1$a'ity Ass$rance Pro#ramme carried o$t +y an indi0id$a'(s) desi#nated +y- and direct'y responsi+'e to mana#ement and ,ho is fami'iar ,ith the test proced$res. Is this indi0id$a'(s) free of in0o'0ement in the cond$ct of the st$dy +ein# ass$red. Responsibilities o# t$e %uality &ssurance Personnel Do the 1A personne' maintain copies of a'' appro0ed st$dy p'ans and "4P9s in $se in the test faci'ity and ha0e access to an $p-to-date copy of the master sched$'e. Do the 1A personne' 0erify that the st$dy p'an contains the information re2$ired for comp'iance ,ith the Princip'es of )ood *a+oratory Practiceand is this 0erification doc$mented. (i) Do the 1A personne' cond$ct inspections to determine if a'' st$dies are cond$cted in accordance ,ith the 5

2%1%2

2%1%3 2.2 2%2%1 (a) (+)

(c)

Princip'es of )ood *a+oratory Practice.

(d)

(e)

(f)

+. 3.1 3%1%1 3%1%2

Do they determine thro$#h inspections that st$dy p'ans and "4P9s ha0e +een made a0ai'a+'e to st$dy personne' and are +ein# fo''o,ed. (iii) Are records of s$ch inspections (st$dy+ased inspectorsfaci'ity-+ased inspectionsand process-+ased inspections) retained. Do the 1A personne' inspect the fina' reports to confirm that the methods- proced$res- and o+ser0ations are acc$rate'y and comp'ete'y descri+ed- and that the reported res$'ts acc$rate'y and comp'ete'y ref'ect the ra, data of the st$dies. Do the 1A personne' prompt'y report any inspection res$'ts in ,ritin# to the mana#ement and to the "t$dy Director- and to the Principa' In0esti#ator(s) and the respecti0e mana#ement,hen app'ica+'e. Do the 1A personne' prepare and si#n a statementto +e inc'$ded ,ith the fina' report- ,hich specifies types of inspections and their dates- inc'$din# the phase(s) of the st$dy inspected- and the dates inspection res$'ts ,ere reported to mana#ement and the "t$dy Director and Principa' In0esti#ator(s)- if app'ica+'e. (This statement a'so ser0es to confirm that the fina' report ref'ects the ra, data)% #$CILI!I"S "eneral Is the test faci'ity of s$ita+'e si6e- constr$ction and 'ocations to meet the re2$irements of the st$dy and to minimi6e dist$r+ance that ,o$'d interfere ,ith the 0a'idity of the st$dy. Does the desi#n of the test faci'ity pro0ide an ade2$ate de#ree of separation of the different acti0ities to ass$re the proper cond$ct of the st$dy. Test system Facilities Does the test faci'ity ha0e a s$fficient n$m+er of rooms or areas to ass$re the iso'ation of test systems and the iso'ation of indi0id$a' pro3ectsin0o'0in# s$+stances or or#anisms 5no,n to +e or s$spected of +ein# +ioha6ardo$s.

(ii)

3.2 3%2%1

3%2%2

3%2%3

3.3 3%3%1

Are s$ita+'e rooms or areas a0ai'a+'e for the dia#nosis- treatment and contro' of diseases- in order to ens$re that there is no $naccepta+'e de#ree of deterioration of test systems. (i) Are there stora#e rooms or areas as needed for s$pp'ies and e2$ipment. (ii) Are these separated from rooms or areas ho$sin# the test systems and do they pro0ide ade2$ate protection a#ainst infestationcontamination and:or deterioration. Facilities #or 'andling Test and Re#erence Items To pre0ent contamination or mi/-$ps- are there separate rooms or areas for receipt and stora#e of the test and reference items- and for the mi/in# of the test items ,ith a 0ehic'e. Are the stora#e rooms or areas separate from rooms or areas containin# the test systems. Are they ade2$ate to preser0e identity- concentration- p$rity and sta+i'ity- and to ens$re safe stora#e for ha6ardo$s s$+stances. &rc$i e Facilities Are archi0e faci'ities pro0ided for the sec$re stora#e and retrie0a' of st$dy p'ans- ra, data- fina' reports- samp'es of test items and specimens. Does the archi0es desi#n and conditions protect the contents from $ntime'y deterioration. )aste Disposal Is the hand'in# and disposa' of ,astes carried o$t in s$ch a ,ay that the inte#rity of st$dies is not 3eopardi6ed. (This inc'$des pro0ision for appropriate co''ection- stora#e and disposa' faci'ities- and decontamination and transportation proced$res) $PP$R$!)S, *$!"RI$LS $ND R"$G"N!S Is the apparat$s (inc'$din# 0a'idated comp$teri6ed systems) $sed for the #eneration- stora#e- and retrie0a' of data- and for contro''in# en0ironmenta' factors re'e0ant to the st$dy- s$ita+'y 'ocated and of appropriate desi#n and ade2$ate capacity. (i) Is the apparat$s $sed in a st$dy periodica''y inspectedc'eanedmaintained and ca'i+rated accordin# to "4P9s. Are records of these acti0ities !

3%3%2

3.!

3.(

4% 4%1

4%2

(ii)

maintained. (iii) 4%3 4%4 Is ca'i+ration- ,here appropriatetracea+'e to nationa' or internationa' standards of meas$rement. Do the apparat$s and materia's $sed in a st$dy interfere ad0erse'y ,ith the test systems. (i) Are chemica's- rea#ents and so'$tions 'a+e'ed to indicate identity (,ith concentration if appropriate)- e/piry date and specific stora#e instr$ctions. (ii) Is information concernin# so$rcepreparation date and sta+i'ity a0ai'a+'e. (The e/piry date may +e e/tended on the +asis of doc$mented e0a'$ation or ana'ysis) !"S! SYS!"*S P$ysical*+$emical Is the apparat$s $sed for the #eneration of physica':chemica' data s$ita+'y 'ocated and of appropriate desi#n and ade2$ate capacity. Is the inte#rity of the physica':chemica' test systems ens$red.

-. (.1 5%1%1 5%1%2 (.2 5%2%1

,iological Are proper conditions esta+'ished and maintained for the stora#e- ho$sin#- hand'in# and care of +io'o#ica' test systems- in order to ens$re the 2$a'ity of the data. 5%2%2 (i) Are ne,'y recei0ed anima' and p'ant test systems iso'ated $nti' their hea'th stat$s has +een e0a'$ated. (ii) If any $n$s$a' morta'ity or mor+idity occ$rs- is this 'ot e/c'$ded from $se in the st$dies- and- ,hen appropriateh$mane'y destroyed. (iii) At the e/perimenta' startin# date of a st$dy- are test systems chec5ed to ens$re that they are free of any disease or condition that mi#ht interfere ,ith the p$rpose or cond$ct of the st$dy. (iv) Are test systems that +ecome diseased or in3$red d$rin# the co$rse of the st$dy iso'ated and treated- if necessary- to maintain the inte#rity of the st$dy. ;

5%2%3 5%2%4

5%2%5

5%2%

5%2%! .. -.1 %1%1 %1%2

Is a'' dia#nosis and treatment of any disease +efore or d$rin# a st$dy recorded. Are records maintained of so$rce- date of arri0a'and arri0a' conditions of test systems. Are +io'o#ica' test systems acc'imati6ed to the test en0ironment for an ade2$ate period +efore the first administration or app'ication of the test or reference item. (i) Does a'' the information needed to proper'y identify the test systems appear on their ho$sin# or containers. (ii) Is appropriate identification #i0en,here0er possi+'e- to indi0id$a' test systems that are to +e remo0ed from their ho$sin# or containers d$rin# the cond$ct of the st$dy. (i) D$rin# $se- is the ho$sin# or containers for test systems c'eaned and saniti6ed at appropriate inter0a's. (ii) Is any materia' that comes into contact ,ith the test system chec5ed for +ein# free of contaminants at 'e0e's that ,o$'d interfere ,ith the st$dy. (iii) Is +eddin# for anima's chan#ed as re2$ired +y so$nd h$s+andry practice. (iv) Is the $se of pest contro' a#ents doc$mented. Are test systems $sed in fie'd st$dies 'ocated so as to a0oid interference in the st$dy from spray drift and from past $sa#e of pesticides. !"S! $ND R"#"R"NC" I!"*S Receipt. 'andling. Sampling and Storage Are records maintained for test item and reference item characteri6ation- date of receipt- e/piry dateand 2$antities recei0ed and $sed in st$dies. Are hand'in#- samp'in# and stora#e proced$res identified in order that the homo#eneity and sta+i'ity are ass$red to the de#ree possi+'e and contamination or mi/-$p is prec'$ded. Do stora#e container(s) carry identification information- e/piry date- and specific stora#e instr$ctions. +$aracteri/ations

(v)

%1%3

-.2

<

%2%1

%2%2

%2%3

%2%4 %2%5

%2%

Is each test and reference system appropriate'y identified e%#% code- CA" n$m+er (Chemica' A+stract "er0ice =e#istry N$m+er)- name- and +io'o#ica' parameters. &or each st$dy- is the identity- inc'$din# +atch n$m+er- p$rity- composition- concentrations- or other characteristics to appropriate'y define each +atch of the test or reference items- 5no,n. In cases ,here the sponsor s$pp'ies the test item- is there a mechanism de0e'oped in cooperation +et,een the sponsor and the test faci'ity- to 0erify the identity of the test item s$+3ect to the st$dy. Is the sta+i'ity of test and reference items $nder stora#e and test conditions 5no,n for a'' st$dies. If the test item is administered or app'ied in a 0ehic'e- is the homo#eneity- concentration and sta+i'ity of the test item in that 0ehic'e determined. (&or test items $sed in fie'd st$dies (e%#% tan5 mi/es)- these may +e determined thro$#h separate 'a+oratory e/periments) Is a samp'e for ana'ytica' p$rposes ta5en from each +atch of test items retained for a'' st$dies e/cept short-term st$dies. S!$ND$RD %P"R$!ING PR%C"D)R"S (i) Does the test faci'ity ha0e mana#ement appro0ed ,ritten "4P9s intended to ens$re the 2$a'ity and inte#rity of the data #enerated +y that test faci'ity. (ii) Are re0isions to "4Ps appro0ed +y the test faci'ity mana#ement. Does each separate test faci'ity $nit or area ha0e c$rrent "4P9s re'e0ant to the acti0ities +ein# performed therein a0ai'a+'e immediate'y. (P$+'ished te/t +oo5s- ana'ytica' methods- artic'es and man$a's may +e $sed as s$pp'ements to these "4Ps) Are de0iations from "4Ps re'ated to the st$dy doc$mented- and ac5no,'ed#ed +y the "t$dy Director and the Principa' In0esti#ator(s)- as app'ica+'e. Are "4P9s a0ai'a+'e for- +$t not 'imited to- the fo''o,in# cate#ories of test faci'ity acti0ities (the detai's #i0en $nder each headin# are to +e considered as i''$strati0e e/amp'es.)> Test and Re#erence Items

/. !%1

!%2

!%3

!%4

!%4%1

1?

!%4%2 a) +) c) !%4%3

=eceipt- identification- 'a+e''in#- hand'in#samp'in# and stora#e% &pparatus. Materials and Reagents Apparat$s> @se- maintenance- c'eanin# and ca'i+ration Comp$teri6ed systems> Aa'idation- operationmaintenance- sec$rity- chan#es contro' and +ac5 $p% (ateria's- =ea#ents and "o'$tions Preparation and 'a+e''in#% Record01eeping. Reporting. Storage and Retrie al2 Codin# of st$dies- data co''ection- preparation of reports- inde/in# systems- hand'in# of data inc'$din# the $se of comp$teri6ed systems% Test System (,here appropriate) =oom preparations and en0ironmenta' room conditions for the test system% Proced$res for receipt- transfer- proper p'acementcharacteri6ation- identification and care of the test system% Test system preparation- o+ser0ations and e/aminations- +efore- d$rin#- and at the conc'$sion of the st$dy% 7and'in# of test system indi0id$a's mori+$nd or dead d$rin# the st$dy% fo$nd

!%4%4 a) +)

c)

d) e) f) !%4%5 0. 3.1 ;%1%1

;%1%2 a)

Co''ection- identification and hand'in# of specimens inc'$din# necropsy and histopatho'o#y% "itin# and p'acement of test systems in test p'ots% 1$a'ity Ass$rance Proced$res 4peration of 1$a'ity Ass$rance personne' in p'annin#- sched$'in#performin#- doc$mentin# and reportin# inspections% P"R#%R*$NC" %# !1" S!)DY Study Plan Does a ,ritten p'an e/ist prior to the initiation of each st$dy. Is the st$dy p'an appro0ed +y dated si#nat$re of the "t$dy Director and 0erified for )*P comp'iance +y 1A personne' as specified in "ection 2%2%1(+). Is the st$dy p'an appro0ed +y the test faci'ity mana#ement and the sponsor- if re2$ired +y nationa' re#$'ation or 'e#is'ation in the co$ntry ,here the st$dy is +ein# performed. Are amendments to the st$dy p'an 3$stified and appro0ed +y dated si#nat$res of the "t$dy Director and maintained ,ith the st$dy p'an.

11

+)

;%1%3

Are de0iations from the st$dy p'an descri+ede/p'ained- ac5no,'ed#ed and dated in a time'y fashion +y the "t$dy Director and:or Principa' In0esti#ator(s) and maintained ,ith the st$dy ra, data. &or short-term st$dies- is the #enera' st$dy p'an accompanied +y a st$dy specific s$pp'ement. (4ptiona') +ontent o# t$e Study Plan Does the st$dy p'an contain at 'east the fo''o,in# information. Identification of the "t$dy- the Test Item and =eference Item A descripti0e tit'e A statement- ,hich re0ea's the nat$re and p$rpose of the st$dy% Identification of the test item +y code or name (I@PACB CA" n$m+er- +io'o#ica' parameters- etc%) The reference item to +e $sed% Information Concernin# the "ponsor and Test &aci'ity Name and address of the sponsor% Name and address of any test faci'ities and test sites in0o'0ed% Name and address of the "t$dy Director% Name and address of the Principa' In0esti#ator(s) and the phases of the st$dy de'e#ated +y the "t$dy Director and $nder the responsi+i'ity of the Principa' In0esti#ator(s)% Dates The date of appro0a' of the st$dy p'an +y si#nat$re of the "t$dy Director% The proposed e/perimenta' startin# and comp'etion dates% Test (ethods =eference to the 4CCD )$ide'ine or other test #$ide'ine or method to +e $sed% Iss$es (,here app'ica+'e) The 3$stification for se'ection of the test system% Characteri6ation of the test system- s$ch as the species- strain- s$+strain- so$rce of s$pp'y- n$m+er+ody ,ei#ht ran#e- se/- a#e- and other pertinent information% The method of administration and the reason for its choice% The dose 'e0e's and:or concentration(s)- fre2$encyand d$ration of administration:app'ication% 12

3.2 ;%2%1 a) +) c) d) ;%2%2 a) +) c) d)

;%2%3 a) +) ;%2%4 ;%2%5 a) +)

c) d)

e)

;%2% 3.3 ;%3%1

Detai'ed information on the e/perimenta' desi#ninc'$din# a description of the chrono'o#ica' proced$re of the st$dy- a'' methods- materia's and conditions- type and fre2$ency of ana'ysismeas$rements- o+ser0ations and e/aminations to +e performed- and statistica' methods to +e $sed (if any)% =ecords A 'ist of records to +e retained +onduct o# t$e Study (i) Is a $ni2$e identification #i0en to each st$dy- and do a'' items concernin# that st$dy carry this identification.

;%3%2 ;%3%3

Are specimens from the st$dy identified to confirm their ori#in. ("$ch identification sho$'d ena+'e tracea+i'ityas appropriate for the specimen and st$dy)% Is the st$dy cond$cted in accordance ,ith the st$dy p'an. Are a'' data #enerated d$rin# the cond$ct of the st$dy recorded direct'y- prompt'y- acc$rate'y- and 'e#i+'y +y the indi0id$a' enterin# the data- and ha0e a'' entries +een si#ned or initia'ed and dated. Are any chan#es in the ra, data made so as not to o+sc$re the pre0io$s entry and ha0e the reasons for the chan#es +een indicated- and dated and si#ned. (i) Is data #enerated as a direct comp$ter inp$t identified at the time of data inp$t +y the indi0id$a'(s) responsi+'e for direct data entries. (ii) Does comp$teri6ed system desi#n pro0ide for the retention of f$'' a$dit trai's to sho, a'' chan#es to the data ,itho$t o+sc$rin# the ori#ina' data. (It sho$'d +e possi+'e to associate a'' chan#es to data ,ith the persons ha0in# made these chan#es- for e/amp'e- +y $se of timed and dated (e'ectronic) si#nat$res)% Are the reasons for the chan#es #i0en.

(ii)

;%3%4 ;%3%5

(iii)

13

2. 4.1 <%1%1

<%1%2 <%1%3

<%1%4

R"P%R!ING %# S!)DY R"S)L!S "eneral Is a fina' report prepared for each st$dy. (In the case of short-term st$dies- a standardi6ed fina' report accompanied +y a st$dy specific e/tension may +e prepared)% Are reports of Principa' In0esti#ators or scientists in0o'0ed in the st$dy si#ned and dated +y them. (i) Is the fina' report si#ned and dated +y the "t$dy Director to indicate acceptance of responsi+i'ity for the 0a'idity of the data. (ii) Is the e/tent of comp'iance ,ith )*P princip'es indicated. (i) Are corrections and additions to a fina' report made in the form of amendments. Do s$ch amendments c'ear'y specify the reason(s) for the corrections or additions and are they si#ned and dated +y the "t$dy Director. (=eformattin# of the fina' report to comp'y ,ith the s$+mission re2$irements of a nationa' re#istration or re#$'atory a$thority does not constit$te a correction- addition or amendment to the fina' report)% +ontent o# t$e Final Report Does the fina' report contain at 'east the fo''o,in# information> Identification of the "t$dy- the Test Item and =eference Item A descripti0e tit'e% Identification of the test item +y code or name (I@PAC- CA" n$m+er- +io'o#ica' parameters- etc)% Identification of the reference item +y name% Characteri6ation of the test item- inc'$din# p$ritysta+i'ity and homo#eneity% Information concernin# the "ponsor and the Test &aci'ity Name and address of the sponsor%% Name and address of any test faci'ities and test sites in0o'0ed% Name and address of the "t$dy Director% Name and address of the Principa' In0esti#ator(s) and the phase(s) of the st$dy de'e#ated- if app'ica+'e% (ii)

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4.2 <%2%1 a) +) c) d) <%2%2 a) +) c) d)

14

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Name and address of scientists ha0in# contri+$ted reports to the fina' report Dates C/perimenta' startin# and comp'etion dates% "tatement A 1A Pro#ramme statement 'istin# the types of inspections made and their dates- inc'$din# the phase(s) inspected- and the dates any inspection res$'ts ,ere reported to mana#ement and to the "t$dy Director and Principa' In0esti#ator(s)- if app'ica+'e% (This statement ,o$'d a'so ser0e to confirm that the fina' report ref'ects the ra, data)% Description of (ateria's and Test (ethods Description of methods and materia's $sed% =eference to 4CCD Test )$ide'ine or other test #$ide'ine or method% =es$'ts A s$mmary of res$'ts% A'' information and data re2$ired +y the st$dy p'an% A presentation of the res$'ts- inc'$din# ca'c$'ations and determinations of statistica' si#nificance% An e0a'$ation and disc$ssion of the res$'ts- and,here appropriate- conc'$sions% "tora#e The 'ocation(s) ,here the st$dy p'ansamp'es of test and reference items- specimens- ra, data and the fina' report are to +e stored% Stora4e and retention of records and materials 7a0e the fo''o,in# +een retained in the archi0es. The st$dy p'an- ra, data- samp'es of test and reference items- specimens- and the fina' report of each st$dy% =ecords of a'' inspections performed +y the 1A Pro#ramme- as ,e'' as master sched$'es% =ecords of 2$a'ifications- trainin#- e/perience and 3o+ descriptions of personne'% =ecords and reports of the maintenance and ca'i+ration of apparat$s% Aa'idation doc$mentation for comp$teri6ed systems% The historica' fi'e of a'' "4P9s% Cn0ironmenta' monitorin# records% Is the materia' contained in the archi0es inde/ed so as to faci'itate order'y stora#e and retrie0a'. (i) Is access to the archi0es 'imited to on'y personne' a$thori6ed +y the mana#ement.

15

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Is mo0ement of materia' in and o$t of the archi0es proper'y recorded.

Is there a doc$mented proced$re for the transfer of materia' stored in the test faci'ity archi0es to the archi0es of the sponsor(s) of the st$dy(s)- in case the test faci'ity #o o$t of +$siness and has no 'e#a' s$ccessor.

D 4r#anisation for Cconomic Cooperation and De0e'opment (4CCD)