United Nations Childrens Fund Supply Division UNICEF Plads F!eepo!" *+-21,, Copenha)en *enma!

Telephone +45-35 27 35 27 Facsimile +45-35 26 94 21 E-mail# s$ppl%&$nice'(o!) ...($nice'(o!)/s$ppl%

TECHNICAL QUESTIONNAIRE FOR PHARMACEUTICAL MANUFACTURERS

To be completed and returned to UNICEF Supply Division, Quality Assurance Centre, Freeport, DK !"## Copen$a%en, Denmar&, 'it$ all re(uested documents attac$ed) T$is in*ormation is re(uested in addition to t$e in*ormation re(uested t$rou%$ t$e re%istration at United Nations +lobal ,ar&et -lace) ''')un%m)or%) Furt$er in*ormation about UNICEF.s purc$ase o* p$armaceutical products and %eneral (uality re(uirements can be *ound on $ttp/00''')unice*)or%0supply0inde12suppliers)$tml 1. GENERAL INFORMATION Name, address, telep$one, email, *a1, Internet address o* t$e company/

2. AFFILIATES

I* t$e company is o'ned by anot$er company, or belon%s to a %roup o* companies, please indicate your position 'it$in t$e structure/

3. REGULATORY ISSUES 3)") Good manufacturing ractic! Indicate t$e +,- standards 4567, -IC S0EU, FDA or ot$er8 'it$ '$ic$ t$e company complies/
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UNI#EF t!c$nica% &u!'tionnair! for $armac!utica% manufactur!r' ( a g ! )1

Copyright Supply Division, UNICEF

United Nations Childrens Fund Supply Division UNICEF Plads F!eepo!" *+-21,, Copenha)en *enma!0

Telephone +45-35 27 35 27 Facsimile +45-35 26 94 21 E-mail# s$ppl%&$nice'(o!) ...($nice'(o!)/s$ppl%

3)!) Manufacturing %ic!nc! for m!dicina% roduct' -lease list t$e p$armaceutical dosa%e *orms you are licensed to manu*acture by t$e National 9e%ulatory Aut$ority and attac$ a copy o* t$e ,anu*acturin% licence4s8 or +,- certi*icate 4it must indicate dosa%e *orms manu*actured8/

3)3) In' !ction Date o* last inspection by t$e National 9e%ulatory Aut$ority/

-lease attac$ a copy o* t$e last inspection report i* it can be made available *or revie' by UNICEF on a con*idential basis) Names o* all ot$er 9e%ulatory Aut$orities and International 7r%anisations '$o $ave inspected t$e company) -lease also state t$e outcome o* t$e inspection/

-lease attac$ a copy o* t$e last inspection report i* it can be made available *or revie' by UNICEF on a con*idential basis) *. MANUFA#TURING :)") Manufacturing 'it!

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UNI#EF t!c$nica% &u!'tionnair! for $armac!utica% manufactur!r' ( a g ! )2

Copyright Supply Division, UNICEF

United Nations Childrens Fund Supply Division UNICEF Plads F!eepo!" *+-21,, Copenha)en *enma!0

Telephone +45-35 27 35 27 Facsimile +45-35 26 94 21 E-mail# s$ppl%&$nice'(o!) ...($nice'(o!)/s$ppl%

-lease state all addresses at '$ic$ manu*acturin% o* p$armaceutical products ta&es place, and indicate '$ic$ year t$e *actory 'as built 4complete one (uestionnaire *or eac$ site8/

:)!) (!r'onn!% -lease indicate t$e name and t$e education o* t$e *ollo'in% &ey sta**/
-

,ana%in% director/ -roduction ,ana%er/

Quality Assurance ,ana%er/ Number o* personnel in total/ Number o* personnel in production/ Number o* personnel in (uality control/

:)3) +!nti%ation ','t!m -lease indicate '$et$er t$e manu*acturin% areas are e(uipped 'it$ controlled ventilation systems/ ;es :):) -ua%it, #ontro% C$emical laboratory <iolo%ical laboratory ,icrobiolo%ical laboratory :)=) #ontract manufactur! -lease indicate i* you underta&e contract manu*acture *or ot$er companies/ ;es Do you subcontract to ot$er companies> ;es No No in $ouse in $ouse in $ouse contracted out contracted out contracted out No

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UNI#EF t!c$nica% &u!'tionnair! for $armac!utica% manufactur!r' ( a g ! )3

Copyright Supply Division, UNICEF

I* yes, please list products and0or services/

United Nations Childrens Fund Supply Division UNICEF Plads F!eepo!" *+-21,, Copenha)en *enma!0

Telephone +45-35 27 35 27 Facsimile +45-35 26 94 21 E-mail# s$ppl%&$nice'(o!) ...($nice'(o!)/s$ppl%

T$is (uestionnaire must be completed by eac$ contract manu*acturer involved in supply o* products to UNICEF) :)?) St!ri%! roduct'. Do you manu*acture sterile products> ;es 5$ic$ ,et$od o* sterilisation is used/ No

Is aseptic manu*acturin% processes simulated 'it$ media *ills t'ice a year *or product time and si@e> ;es No :)A. /!ta0%actam!' Do you manu*acture penicillins or ot$er beta lactam products> ;es No I* yes, does t$is production ta&e place in separate buildin%s> ;es :)B) R!ca%%' Do you $ave a recall procedure>

No

;es

No

-lease indicate si%ni*icant product complaints and any recalls t$e last t$ree years/

:)C) (roduction ca acit, -roduct Tablets Capsules Ampoules Fials, li(uids Fials, dry po'der No o* units per year

Dast yearsE production units

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UNI#EF t!c$nica% &u!'tionnair! for $armac!utica% manufactur!r' ( a g ! )*

Copyright Supply Division, UNICEF

United Nations Childrens Fund Supply Division UNICEF Plads F!eepo!" *+-21,, Copenha)en *enma!0

Telephone +45-35 27 35 27 Facsimile +45-35 26 94 21 E-mail# s$ppl%&$nice'(o!) ...($nice'(o!)/s$ppl%

Fials, lyop$ili@ed 7intments Di(uids -o'der *or oral suspensions Suppositories -enicillin, tablets0capsules -enicillin, po'der *or oral suspension

-enicillin, po'der *or inGection 7t$er, speci*y

Is production capacity *i%ures based on one or more s$i*ts> 4Tic& in appropriate bo18 " 1. (RO2U#TS =)" (roduct %ic!nc!' -lease enclose a list o* all products manu*actured by your company and aut$orised *or sale on t$e domestic mar&et 4country o* ori%in8)

For eac$ licensed product, please cate%orise as *ollo's/ T$e product is mar&eted on t$e domestic mar&et) T$e product is licensed but not mar&eted on t$e domestic mar&et) T$e licence is *or e1port only Kindly also list licences *or eac$ product $eld in ot$er countries/

-lease indicate $o' muc$ in percenta%e your e1port is o* t$e total production/

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UNI#EF t!c$nica% &u!'tionnair! for $armac!utica% manufactur!r' ( a g ! )1

Copyright Supply Division, UNICEF

United Nations Childrens Fund Supply Division UNICEF Plads F!eepo!" *+-21,, Copenha)en *enma!0

Telephone +45-35 27 35 27 Facsimile +45-35 26 94 21 E-mail# s$ppl%&$nice'(o!) ...($nice'(o!)/s$ppl%

-lease also list t$e name o* any contract manu*acturer, '$en a product not is *ully manu*actured by your company

I* possible, please attac$ an indicative price list)

=)!) 2ocum!ntation T$e *ollo'in% product documentation must upon re(uest be available *or all products o**ered to UNICEF/ -roduct composition master *ormula <atc$ manu*acturin% record Startin% materials speci*ication Finis$ed product speci*ication Falidation report Stability report -ac&a%in% and labellin% speci*ications Annual -roduct 9evie'

-lease indicate i* t$is documentation is N7T available *or any o* t$e products on t$e list mentioned above in point =)")

=)3) Sam %!' Are you 'illin% to provide samples o* *inis$ed products and batc$ documentation 4on a con*idential basis8 i* re(uested> =):) Starting mat!ria%'/ Indicate approved startin% material sources *or t$e companyEs maGor products and indicate i* approved D,Fs or Certi*icates o* suitability o* t$e ,ono%rap$ o* t$e European -$armacopoeia are available/

;es

No

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UNI#EF t!c$nica% &u!'tionnair! for $armac!utica% manufactur!r' ( a g ! )3

Copyright Supply Division, UNICEF

United Nations Childrens Fund Supply Division UNICEF Plads F!eepo!" *+-21,, Copenha)en *enma!0

Telephone +45-35 27 35 27 Facsimile +45-35 26 94 21 E-mail# s$ppl%&$nice'(o!) ...($nice'(o!)/s$ppl%

6o' is it ensured t$at active p$armaceutical in%redients are manu*actured in accordance 'it$ +,-> )

3. GM( INS(E#TION Can UNICEF or any ot$er representative desi%nated by UNICEF per*orm an inspection o* t$e ,anu*acturin% site> ;es No

Can t$e National 9e%ulatory Aut$ority participate as observers in t$e audit> ;es No

-lease attac$ a Site ,aster File 4-IC S *ormat8) I* not attac$ed please indicate '$y it is not attac$ed/

,ay UNICEF s$are t$e inspection report 'it$ its partners 567 +eneva, ,SF France, IC9C +eneva and -IC S member states upon re(uest> 4;our company 'ill be noti*ied in case t$e report is s$ared)8 No 4. OT5ER INFORMATION Contact person *or UNICEF/ Email/ Add any ot$er in*ormation/

;es

I $!r!6, c!rtif, t$at t$! information gi7!n in t$i' &u!'tionnair! and t$! attac$m!nt' i' corr!ct. 2at!.

( a g ! )4

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UNI#EF t!c$nica% &u!'tionnair! for $armac!utica% manufactur!r'

Copyright Supply Division, UNICEF

Tit%!. Nam!. Signatur!.

United Nations Childrens Fund Supply Division UNICEF Plads F!eepo!" *+-21,, Copenha)en *enma!0

Telephone +45-35 27 35 27 Facsimile +45-35 26 94 21 E-mail# s$ppl%&$nice'(o!) ...($nice'(o!)/s$ppl%

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UNI#EF t!c$nica% &u!'tionnair! for $armac!utica% manufactur!r' ( a g ! )8

Copyright Supply Division, UNICEF