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INTERNSHIP INTERNSHIP REPORT INTERNSHI INTER NSHIP P AT AT: ENVOY PHARMACEUTICAL (Pvt) LTD.
INTERNSHIP INTERN SHIP BY: BY: Rai Waqas Ali 4th Pr of . L aho r eCo l l e g eOf OfPhar mac e ut i c alSc i e nc e s
Adviser & Supervisor of Internship Report:
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DEDI DEDICATI CATION ON :
I have dediated dediated !" i#te$#shi% &'$ a#d e'$t t' all all !" teahe$s &h' '*#d s*h a+ilit" i# !e i# ENVOY Pha$!ae*tials. Pha$!ae*tials. With'*t With'*t thei$ hel% I &as #'t a+le t' d' !" +est e'$ts.
DURATION DURATION 31 Aug 2015 TO 30 September 2015
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DEDI DEDICATI CATION ON :
I have dediated dediated !" i#te$#shi% &'$ a#d e'$t t' all all !" teahe$s &h' '*#d s*h a+ilit" i# !e i# ENVOY Pha$!ae*tials. Pha$!ae*tials. With'*t With'*t thei$ hel% I &as #'t a+le t' d' !" +est e'$ts.
DURATION DURATION 31 Aug 2015 TO 30 September 2015
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ACKNOWLEDGEMENT:
,ei#- M*sli!s N' A#'&led-e!e#t 'es With'*t P$aisi#- T'
ALLAH ALMIGHTY Knowledge ha no boundar!e and there ! no end to !t" Th! ! what I ha#e $ome to %now wh!le prepar!ng th! repot" It ha been a
good
e&per!en$e
b'
ta%!ng
tra!n!ng
!n
(N)O*
+harma$eut!$al"The whole ta, o- organ!.at!on wa $ooperat!#e and help-ul" I !n$erel' e&pre m' than% / grat!tude to the honorable and repe$ted +rodu$t!on anager
S!r Dr"SARAT TA((D
AA4 who pro#!ded me w!th an opportun!t' o- !nternh!p and to wr!te on u$h a un!ue organ!.at!on I am obl!ged to !ntend m' than% to all ta, member o- (N)O* +har +h arma ma$e $eut! ut!$a $al l -or -or e&tr e&traor aord! d!nar nar' ' gu!d gu!dan an$e $e and and trem tremend endou ou $ooperat!on throughout the tenure o- !nternh!p"
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TABLE OF CONTENTS:
/ I#t$'d*ti'#. / I#d*st$" Ove$vie&. / M't' ' E#v'" Pha$!ae*tial. / Ai! 0O+1etive. / De%a$t!e#ts ' I#d*st$". / T'll Ma#*at*$i#-. / O+se$vati'#. / Dis*ssi'#. / C'#l*si'# 0 Re'!!e#dati'#.
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INTRODUCTION
PHARMACEUTICAL INDUSTRY:
INDUSTRY OVERVIEW 2'*#ded i# se%te!+e$ 3445 E#v'" Pha$!ae*tials has si#e ahieved !a#" !ilest'#es. It is sit*ated at 3678!9 M*lta# R'ad Ma$aa Lah'$e9 Paista#. ,ea*se ' thei$ st$'#- dediati'# t' hi-h q*alit" %$'d*ts a#d se$vies the" have devel'%ed a -$eat %'$t'li' ' I#te$#ati'#al Clie#ts9 T'll Pa$t#e$s9 I#stit*ti'#al ,*"e$s a#d Ma$eti#-. E#v'" %ha$!ae*tials is a# I:O ;44<=344> e$tiied '!%a#" a#d the$e'$e ass*$es that MP ( *$$e#t -''d !a#*at*$i#- %$atie ) a#d LP (-''d la+ %$atie ) a$e st$itl" 'll'&ed at all levels ' !a#*at*$i#- %$'ess. The !a#*at*$i#- ailit" has +ee# %la##ed ee%i#- i# vie& the *%7t'7date MP $*les E#v'" Pha$!ae*tial ahieved a#'the$ !ilest'#e +" esta+lishi#- a hi-h7teh I#1et a+le Pla#t &hih is '!%letel" dediated '$ !a#*at*$i#- ' e%hal's%'$i# i#1eti'#s. This i#d*st$" has all the esse#tial :eti'#s ' Medii#e. The" have a la"'*t a'$di#- t' the i#te$#ati'#al sta#da$d. Itis e#t$all" ai$ '#diti'#ed a#d have latest !ahi#e$". E#v'" is a$!ed &ith the !'de$# eq*i%!e#t '$ %$'d*ti'#9 q*alit" '#t$'l a#d q*alit" ass*$a#e. E#v'" !a#*at*$e all '$!s ' d$*- delive$" s"ste!s lie9 s'lid '$als (ta+lets9 a%s*les9 d$" s*s%e#si'#s)9 liq*id '$als (s"$*%s9 s*s%e#si'#s)9 a#d i#1eta+le.
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MOTO OF ENVOY PHARMACEUTICAL
(N)O* +harma$eut!$al ! a name o- trut8 e&$ellen$e and ual!t' !n the pharma$eut!$al !ndutr' o- +a%!tan" 9e tr!#e to er#e the human!t' !n the bet po!ble wa' b' pro#!d!ng them a w!de range o- !nno#at!#e and ual!t' med!$!ne" Th! ! be$aue (n#o':
AIMS & OBJECTIVES: 2'll'&i#- a$e the ai!s 0 '+1etives ' ENVOY %ha$!ae*tials= /
/ /
/
/
To etabl!h the mar%et!ng relat!onh!p w!th the lead!ng !nternat!onal pharma$eut!$al $ompan!e !n -uture b' laun$h!ng the!r !nno#at!#e and reear$h produ$t To d!$o#er new wa'8 te$hnolog!e and produ$t to manage health To promote the growth and u$$e o- !t ao$!ate and !nternat!onal $ompet!t!#ene and e&port per-orman$e o!ndutr'" To o,er e,e$t!#e olut!on -or #ar!ou health$are $hallenge8 w!th produ$t and er#!$e that are well;-o$ued8 w!th!n $utomer rea$h and $ontr!bute to !mpro#ed health$are othe people o- +a%!tan" To de#elop and promote +a%!tan !mage a an attra$t!#e manu-a$tur!ng g!ant !n !nno#at!#e health$are produ$t"
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Products Thee are -ollow!ng -ew produ$t o- (N)O* +harma$eut!$al: Akurat !C"#$#%
Ca%?:*s @44 0 <44 !-
E'()*r !C"a+,*r
Ca%?s*s?s"% 34!- B<3 !-
Kombat (Cephradie!
Tab=u250>500 mg
"#$id (%&ithrom#ci!
?ap 250 mg
%cip (Cipro'oaci!
Tab250@500mg
%$i)at (*e+o'oaci!
Tab 250"500 mg
%,ido (Do#c#c$ie! -ri$)e (Ce.triaoe! Ometor (Omepra&o$e!
?ap100 mg In1 gm ?ap 20 mg
Ema)e (Esomepra&o$e!
?ap 20860 mg
Des)e (De$oratadie!
Tab 5 mg
Decoa&o$e (/$ucoa&o$e! ?ap" 150mg Esp
(Ce.ac$or!
Drop
TOLL MANUFACTURING:
B
A# a$$a#-e!e#t i# &hih a '!%a#" (&hih has s%eialiedeq*i%!e#t) %$'esses $a& !ate$ials '$ se!ii#ished -''ds '$ a#'the$ '!%a#". It is als'alled T'll %$'essi#-. ENVOY Pha$!ae*tial *$$e#tl" T'll !a#*at*$i#- &ith 'll'&i#- %ha$!ae*tial I#d*st$ies=
1 Aqmar Pharmaceutical, Karachi . 2 Genista Pharmaceutical, Karachi . 3 Dermagen Laboratories, Lahore . 4 Relliance Pharmaceutical, Lahore . 5 inlet Pharmaceutical, Lahore ! A"ee Pharmaceutical, Lahore # $o%ote& Pharmaceutical, Lahore $ature o' (rgani"ation) $ature o' the *n%o+ Pharmaceutical P%t- Lt. is consumer consumable. /t is 0ro%iing the qualit+ 0roucts u0 to the mar& to im0ro%e the health o' the 0atients b+ targeting a ie rage o' octors 'rom general 0h+sicians to consultants-.
C
DEPARTMENTS OF INDUSTRY: ⇒
T- C*%)a'. #( #'/*,/0 #' t- %a'u"a+tur#'1 *" a,%*(t a,, (1%'t( *" )r*0u+t( -a/#'1 #t( #'0)'0't %a'u"a+tur#'1 (+t#*'( 2-#+- ar +*'tr*,,0 2#t- +'tra,,. a#r3-a'0,#'1 (.(t%4 T-r ar "*,,*2#'1 %a#' 0)art%'t( *" ENVOY P-ar%a+ut#+a,4
9are houe Raw ater!al Store urant!ne Area !n!h Eood Store +rodu$t!on department ual!t' $ontrol department +ro$urement department Fu!ne de#elopment department I"T department ar%et!ng department
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WARE HOUSE It $eeives $a& !ate$ial. U#til this !ate$ial is lea$ed it is $e!ai#s the$e. Te!%e$at*$e a#d h*!idit" is e%t *#de$ '#t$'l.
anager tore / d!tr!but!on D!tr!but!on !n $harge S'tem operator Raw mater!al operator !n!h Eood operator
PREMISES: / 5 / /
/ / / / / /
It is &as &ell sit*ated9 &ell laid '*t9 tid"9 lea# a#d &ell se*$ed e#a+li#-''d %$ese$vati'# ' $a& !ate$ial9 %aa-i#- !ate$ial a#d i#ished %$'d*ts. Te!%e$at*$e &as !ai#tai#ed +et&ee# <754 6C. H*!idit" &as set +et&ee# 574. F'+ des$i%ti'# ' the &a$eh'*se i#l*ded= Res%'#si+ilit" t' '#t$'l i#ve#t'$" ' st's (2i#ished9 Paa-i#- a#d Ra& !ate$ial :t'$es). Chei#- %h"sial st's $e-*la$l". P$e%a$i#- Dail" 0 Weel" :t's Re%'$ts. I# ENVOY &a$e h'*se &as se%a$ated i#t'= Ra& !ate$ial st'$e. Pai#- !ate$ial st'$e. 2i#ish -''d st'$e.
RAW MATERIAL STORE: Ra& !ate$ial st'$e &as *$the$ divided i#t' 'll'&i#-=
1" uarant!ne area +a$%!ng mater!al uarant!ne • Raw mater!al uarant!ne • 2" (&$!p!ent area 3" A$t!#e pharma$eut!$al !ngred!ent • Toll (n#o' • 6" D!pen!ng area
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or ant!b!ot!$ or $ephalopor!n • or general mater!al • 5" ?h!ller area •
7UARANTINE: All $a& !ate$ials9 '!%'#e#ts9 %aa-i#-9 a#d la+eli#- !ate$ials a$e held i# '*$ Gq*a$a#ti#eG a$ea *#til the" a$e sa!%led9 tested a#d?'$ ea!i#ed9 a#d $eleased '$ *se +" '*$ Gq*alit" '#t$'l la+'$at'$"G. The sa!%li#- is %e$'$!ed a'$di#- t' s%eii %$'ed*$es +" t$ai#ed %e$s'##el.
Th! area ! d!#!ded !nto two e$t!on
Pac,i) materia$ 0uaratie In th! e$t!on pa$%!ng mater!al -or d!,erent doage -orm ! %ept under re$ommended and $ontrolled atmophere Ra1 materia$ 0uaratie In th! e$t!on raw mater!al ! %ept under normal $ond!t!on a$t!#e pharma$eut!$al !ngred!ent ! %ept !n 15;25 ?G8 e&$!p!ent are %ept at 25 ?G !n ube$t!on o- th! area Chi$$er area In th! area normall' temperature en!t!#e produ$t are %ept !n eparate area to pre#ent them -rom damage or detor!at!on" Dispesi) area D!pen!ng area ! alo preent !n raw mater!al e$t!on where d!pen!ng ! per-ormed under manu-a$tur!ng order o- a produ$t at t!me o- d!pen!ng 6 peronnel> hould be preent there to $he$% the pro$e o- d!pen!ng a$$ord!ng to SO+"
+rodu$t!on pharma$!t
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"A pharma$!t Raw mater!al tore pharma$!t Raw mater!al d!pener
PURCHASE ORDER FOR RAW MATERIAL: A st' delive$" $e%'$t is %$e%a$ed. Chei#- ' d'*!e#tati'# is d'#e.COA is iss*ed. The Assista#t :t'$e Ma#a-e$ $eeives the $a& !ate$ials a#d t$a#se$s it t' the q*a$a#ti#e &ith the la+el J*a$a#ti#edK +e'$e -etti#- it t$a#se$ t' the +*l ate$ lea$a#e $'! JCD. The JCD 'llets the sa!%le a#d $e%'$ts '$ its $elease9 it is a'$di#- t' the s%eiiati'#s '$ $e1eti'# i #'t. Ate$ $e1eti'# $'! J*alit" C'#t$'l De%a$t!e#t9 $ed Re1etedK sli% is %asted '# eah ' the J*a$a#ti#ed !ate$ial a#d the 7uara't#'0 K sli% is $e!'ved. Ate$ $eleased +" the J*alit" C'#t$'l De%a$t!e#t9 -$ee# R,a(0K :li% is %asted '# eah ' the J*a$a#ti#ed !ate$ial a#d the 7uara't#'0 K sli% is $e!'ved. The !ate$ial $eleased i#'$!ati'#s is e#te$ed i# the !ate$ial l'- sheet. The :t'$e 8ee%e$ !a#a-es t' t$a#se$ the RM t' the +*l &ith #eessa$" i#'$!ati'# %asted '# it. T&' '%ies ' RN ate$ $elease ' R?M $'! JC a$e %$'%'sed. O#e '%" ' RN is $etai#ed +" st'$e ee%e$ a#d '#e '%" is se#d t' a'*#ts de%a$t!e#t '$ 'sti#-. The :t'$e 8ee%e$ (Ra& Mate$ial) t$a#se$s &h'le the '#si-#!e#t ' the !ate$ial &ith the hel% ' seti'# &'$e$s +" !ea#s ' t$'lle"9 lite$ t' the +*l st'$e.
ISSUANCE OF RAW MATERIAL: The &ei-hi#- ' $a& !ate$ials is a$$ied '*t i# the %$ese#e ' %ha$!aist. P$'d*ti'# Pha$!aist hes all the Ra& Mate$ial +" &ei-ht?v'l*!e '# the &ei-hi#- +ala#e a'$di#- t' !a#*at*$i#- '$de$. Ate$ &ei-hi#-9 the $a& !ate$ial is t$a#se$$ed i# the $eleva#t seti'# ' %$'d*ti'# de%a$t!e#t. The '%" ' the !a#*at*$i#- '$de$ is e%t +" the Assista#t :t'$e Ma#a-e$ '$ $e'$d a#d a#'the$ '%" is -ive# t' %$'d*ti'# %ha$!aist.
DOCUMENTATION: 2'll'&i#- d'*!e#tati'#s &e$e d'#e i# &a$e h'*se at die$e#t sta-es= /
Te!%e$at*$e?h*!idit" ha$t.
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/ / / / / /
Dis%e#si#- l'- +''. Ra& !ate$ial $eq*isiti'#. Ra& !ate$ial a#al"sis $e%'$t. Req*est '$ $etest. Ce$tiiate ' a#al"sis. Iss*a#e ' sli%s (Pi# sli%= !ate$ial ide#tiiati'#9 Yell'& sli%= sa!%led at JC9 $ee# sli%= %assed $'! JC).
PRODUCTION AREA P$'d*ti'# tea! is '!!itted t' %$'d*e hi-hest q*alit" %$'d*ts9 &hih a# satis" the #eeds ' +'th d't'$s a#d %atie#ts. The %$'d*ti'# tea! e#deav'$s t' !a#*at*$e %$'d*ts that a$e 'st7eetive th$'*-h +est *tiliati'# ' thei$ $es'*$es. This de%a$t!e#t is &ell eq*i%%ed &ith latest eq*i%!e#t. Wa$#i#- i# i#d*st$"= Y'* a$e e#te$i#- t' P$'d*ti'# A$ea %lease &ea$9 / / /
Ca%. Ove$all. :h'es 've$ '$ ha#-e "'*$ sh'es.
I# ENVOY %ha$!ae*tial P$'d*ti'# A$ea is divided i#t' 'll'&i#- seti'#=
2eera$ Tab$et Sectio 2eera$ Capsu$e Sectio Ora$ *i0uids Sectio Dr# Po1der I3ectib$e Sectio Cepha$osporis (Ora$! Sectio
The Ce%hal's%'$i# (O$al) :eti'# has +ee# *$the$ divided i#t' t&' a$eas
i.e. / Ce%hal's%'$i# D$" P'&de$ :eti'#. / Ce%hal's%'$i# Ca%s*les :eti'#. A'0 -a/ t- ,at(t %a+-#'r. #'+,u0#'1: / C'#e Mie$.
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/ De7h*!idiie$. / :e!i7A*t'!ati Ca%s*le 2illi#- Mahi#e. / ,'ttle ,l'&i#- Mahi#e. / :e!i7A*t'!ati P'&de$ 2illi#- Mahi#e. ⇒
Ro$e o. productio departmet
9hole pharma$eut!$al tand on th! department anu-a$tur!ng o- d!,erent pharma$eut!$al produ$t are $ontrolled b' th! department Th! department produ$e tablet $apule oral l!u!d preparat!on !n !ndutr' and other pharma$eut!$al doage Role o- produ$t!on department !n !ndutr' ! to ma%e ual!t' med!$!ne
Procedure o. mau.acturi) i productio area
In produ$t!on area -ollow!ng euen$e ! -ollowed -or proper manu-a$tur!ng o- med!$!ne
Eenerat!on o- "O Hmanu-a$tur!ng order under !ntru$t!on o- bu!ne de#elopment department that pa bu'er order omed!$!ne to produ$t!on department "O ! $he$%ed b' "? department A+I uant!t' ! $he$%ed and !gned b' "? !- uant!t' ! w!th!n re!gn otherw!e !t w!ll be ree$ted "O ! ent to raw mater!al tore and d!pened a$$ord!ng to $E+ D!pened mater!al ! h!-ted !nto produ$t!on area -or -urther pro$e!ng and manu-a$tur!ng o- med!$!ne Oral l!u!d preparat!on pro$edure ! d!,erent tablet and $apule re u!t d!,erent -rom l!u!d preparat!on all thee w!ll be d!$ued later or ter!le preparat!on ter!le mater!al ! d!pened !n ter!le area under lam!nar a!r Jow hood
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Persoe$ i Productio departmet
Thee are -ollow!ng peronnel !n produ$t!on department
+rodu$t!on manager A!tant produ$t!on manager Tablet e$t!on !n;$harge ?apule e$t!on !n;$harge Oral l!u!d e$t!on !n;$harge Dr' powder !ne$table e$t!on !n;$harge +a$%!ng pharma$!t wor%er
TABLET SECTION: “Tablets are unit solid dosage form of medicament or medicaments with or without suitable diluents. T#pes o. tab$ets mau.actured i ENVOY4
HAn$!p HAl!gant HDel!de H'od!ne
STEPS INVOLVED IN TABLET MANUFACTURING: 5 DISPENSING OF RAW MATERIAL: Ta+letti#- %$'ess sta$ts &ith dis%e#si#- ' ative i#-$edie#ts. Wei-h a#d dis%e#se s"ste! +e-i#s &ith a %ha$!aist -etti#- a +ill ' !ate$ials '$ i#-$edie#ts that !ae *% a $ei%e '$ a +ath t' +e !a#*at*$ed. Eah !ate$ial !*st +e -athe$ed $'! a &a$eh'*se. The# it is ve$iied as the %$'%e$ !ate$ial9 a$e*ll" &ei-hed9 heed a-ai#9 a#d i#all" $eaded '$ !ii#- i# the $ei%e.
5 DRY MI8ING: Ri++'# !ie$ is *sed '$ !ii#-.
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RIBBON MI8ER
5 WET MI8ING: Ate$ d$" !ii#-9 &et !ii#- is d'#e i# the $i++'# !ie$.
/ WET GRANULATION: Wet -$a#*lati'# is *sed '$ &et -$a#*lati'# a#d !esh sie @ 0 a$e *sed.
/ DRYING: / /
2,D (2l*idied ,ed D$"e$). O$ T$a" d$"e$ is *sed '$ the %*$%'se ' d$"i#-.
1<
FLUIDI9ED BED DRYERTRAY DRYER
5 DRY GRANULATION: Osillati#- -$a#*lat'$ is *sed '$ d$" -$a#*lati'# 0 !esh sie *sed is <.
1B
OSCILLATING GRANULATOR
5 LUBRICATION & FINAL MI8ING: 2i#al !ii#- is d'#e i# DC (D'*+le C'#e) !ie$.
DOUBLE CONE MI8ER
5 COMPRESSION : R'ta$" ta+let !ahi#e is *sed '$ '!%$essi'#. %7<6a#d P755 +ei#- *sed.
5 COATING: :%$a" *# (Hi-h Eiie#" C'ati#- Mahi#e) 0 Thi''ta is *sed '$ 'ati#- ' ta+lets.
SPRAY GUN MACHINE
5 LABELING & PACKING: T&' t"%es ' %ai#- is d'#e= / /
Al*7PVC. Al*7Al*.
Ta+lets a$e %aa-ed i#t' st$i% a#d +liste$ %aa-i#- a#d the# i#all" i# shi%%e$s.
Al*7PVC Pai#-= 2'$ Al*7PVC %ai#- Al*7PVC +liste$i#- !ahi#e is *sed.
a$e
1C
:%eiiati'#= / /
Havi#- heate$ i# sta$t. ,ath #'. 0 E%i$" date.
ALU3PVC PACKING MACHINE
Al*7Al*Pai#-=
2'$ Al*7Al* %ai#- Al*7Al* +liste$i#- !ahi#e is *sed.
:%eiiati'#= / / / /
5 %i#h. Te!%e$at*$e <@47<4C. ,ath #'. 0 E%i$" date is %$i#ted. :eali#- 'il.
ALU3ALU PACKING MACHINE
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CAPSULE SECTION: “Capsules are solid unit dosage form of medicament.” ollow!ng are ome e&le o- $apule manu-a$tured b' (N)O*@
Ometor (mage 'l!d A%urate
HOmepra.ole H(omepra.ole HA.!throm'$!n H?e&!me
STEPS INVOLVED IN CAPSULE MANUFACTURING: 5 DISPENSING OF RAW MATERIAL : Ca%s*lati'# %$'ess sta$ts &ith dis%e#si#- ' ative i#-$edie#ts. Wei-h a#d dis%e#se s"ste! +e-i#s &ith a %ha$!aist -etti#- a +ill ' !ate$ials '$ i#-$edie#ts that !ae *% a $ei%e '$ a +ath t' +e !a#*at*$ed. Eah !ate$ial !*st +e -athe$ed $'! a &a$eh'*se. The# it is ve$iied as the %$'%e$ !ate$ial9 a$e*ll" &ei-hed9 heed a-ai#9 a#d i#all" $eaded '$ !ii#- i# the $ei%e.
5 FILLING OF CAPSULE: The !it*$e is illed i# e!%t" a%s*le. ENVOY %ha$!ae*tial9 %$ese#ts a# el*sive a$$a" ' a%s*le illi#- !ahi#e$". This a%s*le seti'# !ahi#e$" is se!i a*t'!ati. Ca%s*le seti'# !ahi#e$" is si!%le t' '%e$ate.
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CAPSULE FILLING MACHINE
5 CAPSULE POLISHING: Ate$ a%s*le illi#- a%s*les &e$e %'lishes i# *ll a*t'!ati a%s*le %'lishi#- !ahi#e.
CAPSULE POLISHING MACHINE
5 LABELING & PACKING: T&' t"%es ' %ai#- is d'#e= / /
Al*7PVC. Al*7Al*.
Ca%s*les a$e %aa-ed i#t' st$i% a#d +liste$ %aa-i#a#d the# i#all" i# shi%%e$s
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INJECTABLE SECTION: 2'$ i#1eta+les the$e is a #eed ' ste$ile a$ea. I# %$atial the te$! ste$ile a$ea is -e#e$all" $e%laed +" lea# $''!. Clea# $''!s i# %ha$!ae*tial i#d*st$" a$e lassiied +" the lea#li#ess ' thei$ ai$. A'$di#- t' 2ede$al sta#da$d 34;D lass li!its a$e deided a'$di#- t' the #*!+e$ ' %a$tiles eq*al t' a#d -$eate$ tha# 4. !! i# '#e *+i ''t ' ai$.STERILE ROOM Akurat !C"#$#%
:*s <44 !-
E'()*r !C"a+,*r
:*s <3 !-
SYRUP SECTION: A viscous concentrated solution of a sugar, such as sucrose, in water or other aqueous liquid; combined with other ingredients, such a solution is used as a flavored vehicle for medications.” S'rup are manu-a$tured b' (N)O* ! •
Anpor H?e-a$lor
STEPS INVOLVED IN SYRUP MANUFACTURING: / / / / /
Dis%e#si#- ' i#-$edie#ts. P$e%a$ed si!%le s"$*%. Add i#-$edie#ts '#e +" '#e. 2illi#- ' s"$*%. La+eli#- 0 Pai#-.
APPARATUS:
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/ / / / /
:ilve$ s'# !ie$ (544 0 3444 lite$s). R.O &ate$ st'$a-e ta#. D'*+le st$ea! 1aet. :"$*% t$a#se$ %*!%. A*t'!ati +'ttle illi#- (@ #'els).
SYRUP FILLING MACHINE ⇒
Suspesio
A +harma$eut!$al upen!on ! a $oare d!per!on !n wh!$h !nternal phae ! d!pered un!-orml' throughout the e&ternal phae" The !nternal phae $on!t!ng o- !noluble ol!d part!$le ha#!ng a pe$!$ range o- !.e wh!$h ! ma!nta!ned un!-orml' throughout the upend!ng #eh!$le w!th a!d o- !ngle or $omb!nat!on o- upend!ng agent" The e&ternal phae Hupend!ng med!um ! generall' aueou !n ome !ntan$e8 ma' be an organ!$ or o!l' l!u!d -or non oral ue" In (N)O* -ollow!ng upen!on are prepared •
A%urate H?e&!me
•
Kombat H?ephrad!ne
DRY POWDER SUSPENSION SECTION: C'!!e$ial !a#*at*$e$s %$'vide the! i# d$" %'&de$ '$ -$a#*les '$! '$ $e'#stit*ti'# &ith %$es$i+ed a!'*#t ' %*$iied &ate$.
STEPS INVOLVED IN DRY POWDER SUSPENSION MANUFACTURING :
26
/ / / / /
Dis%e#si#- ' i#-$edie#ts. Red*ti'# ' sies ' i#-$edie#ts. Mii#- ' all i#-$edie#ts. 2illi#-. La+eli#- 0 %ai#-.
APP;ARATUS: 5 5 5 5
2it !ill. C'#e !ie$. Deh*!idiie$. 2illi#- !ahi#e.
DRY POWDER SUSPENSION FILLING MACHINE
PACKING ROOM: I# ENVOY %ha$!ae*tial i#d*st$" the$e a$e 3 %ai#- hall.
INSTRUCTIONS FOR PACKING:
•
Pai#- a$ea !*st +e lea#ed &ith dete$-e#t. Pai#- +elt !*st '#tai# the ide#tiiati'# sli%. Mate$ial &hih is t' %aed sh'*ld +e $eleased '$ %ai#- +" J*alit"
•
ass*$a#e de%a$t!e#t. ,e'$e sta$i#- the %ai#-9 -et li#e lea$a#e $'! J*alit" Ass*$a#e
•
de%a$t!e#t. All the %aa-i#- !ate$ial ' the %$'d*t t' +e %aed sh'*ld +e heed
• •
•
a#d a%%$'ved +" I#7ha$-e %ha$!aist a#d J.A i#s%et'$ $es%etivel". N' i$$eleva#t !ate$ial sh'*ld + %$ese#t i# %ai#- a$ea.
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•
,ath Ma#*at*$i#- Re'$d sh'*ld +e %$ese#t i# %ai#- a$ea d*$i#-
•
%ai#-. :hi%%e$ %aed !*st '#tai# the %$'%e$ ide#tiiati'# shi%. T$a#se$ the shi%%e$s t' 2i#ished ''ds :t'$e at the '!%leti'# '
•
%aa-i#- %$'ess ate$ -etti#- a%%$'val. :hi%%e$ i# 2i#ished ''ds :t'$e !*st '#tai# the ide#tiiati'# sli% $eleased
•
• •
+" J*alit" C'#t$'l de%a$t!e#t. Please the $e1eted !ate$ial se%a$atel" i# a '#tai#e$ la+eled as Re1etedK. At the '!%leti'# ' %ai#- %$'ess9 '*#t the $e1eted !ate$ial .
7UALITY CONTROL DEPARTMENT: J*alit" is '*$ %$i'$it".K J*alit" is #eve$ a# aide#t9 al&a"s the $es*lt ' i#telli-e#t e'$t.K The q*alit" '#t$'l de%a$t!e#t is $es%'#si+le t' e#s*$e that all !ate$ials !eet the esta+lished $ite$ia th$'*-h'*t all %hases ' the %$'ess. Ra& !ate$ials9 '!%'#e#ts9 a#d %aa-i#- a#d la+eli#- a$e ea!i#ed a#d tested a'$di#- t' a $i-'$'*s &$itte# %$'-$a! desi-#ed t' ass*$e *#i'$!it" $'! +ath t' +ath. Eve$" $a& !ate$ial $eeived is tested '$ ide#tit" a#d '#'$!a#e t' s%eiiati'#s. Eve$" +'ttle9 a%9 a#d la+el is ea!i#ed t' ass*$e that the" !ath the &$itte# s%eiiati'#s. D*$i#- the !a#*at*$e ' all +athes ' all %$'d*ts9 i#7%$'ess sa!%les a$e tested a#d the $es*lts d'*!e#ted. I a#" $es*lts all '*tside ' the &$itte# s%eiiati'#s9 the %$'d*t is $e1eted a#d the i#'$!ati'# is s*+!itted t' the $esea$h a#d devel'%!e#t -$'*% '$ eval*ati'# a#d *$the$ dis%'siti'#. :a!%les ' i#ished9 %aa-ed %$'d*t a$e tested '$ sta+ilit" t' all'& '$ dete$!i#ati'# ' e%i$ati'# dati#-. Aele$ated sta+ilit" testi#- as &ell as $eal ti!e sta+ilit" testi#- isd'#e '#*$$e#tl" t' validate the $es*lts ' the tests.
7UALITY POLICY: /
T' -ai# *st'!e$s satisati'# th$'*-h !a#*at*$i#- a#d %$'vidi#- hi-h q*alit" %ha$!ae*tial %$'d*ts. While +elievi#- i# '#ti#*al i!%$'ve!e#t ' '*$ s"ste!.
27
/
T' ahieve s*stai#ed -$'&th i# !a$et sha$e +" devel'%i#- satisied *st'!e$s. / Health" e#vi$'#!e#t t' devel'% dediated %$'essi'#al tea!s i# '$de$ t' se$ve i# the +est i#te$est ' ete$#al a#d i#te$#al *st'!e$s. :*%%lie$s a#d sha$e h'lde$s. / T' +e#eit the '!!*#it" +" ad'%ti#- e#vi$'#!e#t $ie#dl" %'liies a#d esta+lishi#- sta#da$ds ' ethis. / T' i!%$'ve the sta#da$d ' lie th$'*-h the val*e ' devel'%i#- i##'vative %$'d*ts +" $esea$h a#d devel'%!e#t. A#d t' %*$s*e T'tal J*alit" Ma#a-e!e#t.
The I:O dei#iti'# states that q*alit" '#t$'l is the '%e$ati'#al teh#iq*es a#d ativities that a$e *sed t' *lill $eq*i$e!e#ts '$ q*alit". J*alit" '#t$'l is a %$'ess '$ !ai#tai#i#- sta#da$ds a#d #'t '$ $eati#- the!. The q*alit" '#t$'l de%a$t!e#t has the $es%'#si+ilit" a#d a*th'$it" t' a%%$'ve '$ $e1et all '!%'#e#ts9 d$*- %$'d*t '#tai#e$s9 l's*$es9 i#7%$'ess !ate$ials9 %aa-i#!ate$ial9 la+eli#-9 a#d d$*- %$'d*ts. Ativities ' J*alit" '#t$'l de%a$t!e#t i# ENVOY &e$e= /
/ / / / / / / / / /
Testi#- a#d $elease '$ $e1eti'# ' all i#'!i#- $a& !ate$ials9 %ai#!ate$ials9 i#7%$'ess ? i#te$!ediates a#d i#ished %$'d*ts as %e$ s%eiied s%eiiati'#s. Mai#tai#i#- testi#- $e'$ds as %e$ sta#da$d %$'ed*$es '$ $a& !ate$ials9 %ai#- !ate$ials9 i#7%$'ess ? i#te$!ediates a#d i#ished %$'d*ts. Cali+$ati'# ' la+'$at'$" i#st$*!e#t ? eq*i%!e#t. Pe$'$!i#- sta+ilit" st*d". A#al"tial !eth'd validati'#. P$e%a$ati'# ' sta#da$d v'l*!et$i s'l*ti'#s a#d !ai#tai# sta#da$diati'# $e'$d. Mai#tai# La+eli#- %$'ed*$e at all the sta-es a#d $e'$ds. Mai#tai# &'$i#- ? $ee$e#e sta#da$d $e'$d ' %$'d*ts. A#al"sis ' '!%lai#t sa!%les as a#d &he# $eq*i$ed. 2'll'& saet" #'$!s at all the sta-e d*$i#- ha#dli#- ' he!ials a#d *si#i#st$*!e#ts. 2'll'& -''d la+'$at'$" %$aties.
2<
FLOW CHART OF 74C Ra& Mate$ial I#s%eti'#
Ra& Mate$ial
Reei%t
Ve$iiati'#
:a!%li#-
U#de$ Test
J.C Testi#-
A%%$'ved
Re1eted
2'$ !a#*at*$i#-
Ret*$# t' s*%%lie$?Dest$*ti'#
2B
2C
FINISHED PRODUCT INSECPTION C'!%leti'# ' ,ath ' 2i#ished %$'d*ts
:a!%li#- +" J.A
U#de$ Test
J.C testi#-
P$e%a$ati'# ' Re%'$t 0 hei#-
A%%$'ved
2'$ Dis%ath
Re1eted
Re%$'ess? Dest$*ti'#
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5ua$it# Cotro$ test .or materia$ b# 56C departmet or d!,erent mater!al and doage -orm d!,erent tet are per-ormed8 -ollow!ng o- them are
•
Test .or Ra1 "ateria$
or tet!ng o- raw mater!al -ollow!ng tet are per-ormed a$$ord!ng to SO+ or re-eren$ed et b' uppl!er •
Descriptio or Ph#sica$ appearace H $r'tall!ne8 powder8 mell8 $olor8
•
So$ubi$it# Holub!l!t' ! $he$% b' d!ol#!ng !n al$ohol8 $hloro-orm or !n water !- ubtan$e organ!$ !n nature and non polar t w!ll d!ol#e !n al$ohol and $hloro-orm and !ubtan$e ! !norgan!$ n polar !n nature w!ll ea!l' d!ol#e !n water
•
Ideti7catio H!dent!ed b' u!ng TIR8 T4?8 U) pe$trometer
•
p8 H$he$%ed b' pL meter pL hould be w!th!n range a re$ommended b' oM$!al boo%
•
Viscosit# H#!$o!t' ! $he$%ed b' #!$ometer and !t hould be w!th!n range a re$ommended b' oM$!al boo%
•
%ssa# Hper$entage pur!t' o- ample ! $he$%ed b' anal'.!ng the ample b' u!ng U") pe$trometer or L+4?8 TIR but motl' ued apparatu ! U") pe$trophotometer *OD9 *oss o Dr#i) 9t" o- empt' +etr!;d!h
A
31
9t" o- +etr!;d!h Sample F 9t" o- ample
F;A ?
A-ter dr'!ng at 105?G -or 30 m!nute wt" o- +etr!;d!h ample D D!,eren$e between wt" be-ore dr'!ng and a-ter dr'!ng F;D ( LOD =
¿
•
Diffrence x 100 Wt.of Sample
E x 100 = E c
Test .or Tab$ets
or n!hed produ$t -ollow!ng tet are per-ormed •
Descriptio or Ph#sica$ appearace H $r'tall!ne8 powder8 mell8 $olor8 !.e8 hape
•
Ideti7catio H!dent!ed b' u!ng TIR8 T4?8 U) pe$trometer
•
%ssa# Hper$entage pur!t' o- ample ! $he$%ed b' anal'.!ng the ample b' u!ng U") pe$trometer or L+4?8 TIR but motl' ued apparatu ! U") pe$trophotometer
•
Shii) test
•
Disso$utio time Pac,a)i) test Direct $oss test or bul% onl' aa' ! per-ormed to $he$% !t per$entage pur!t'
32
•
Test .or capsu$es or $apule -ollow!ng tet are per-ormed
•
Descriptio or Ph#sica$ appearace H $r'tall!ne8 powder8 mell8 $olor8 !.e8 hape
•
Ideti7catio H!dent!ed b' u!ng TIR8 T4?8 U) pe$trometer
•
%ssa# Hper$entage pur!t' o- ample ! $he$%ed b' anal'.!ng the ample b' u!ng U") pe$trometer or L+4?8 TIR but motl' ued apparatu ! U") pe$trophotometer
•
Shii) test
•
Disso$utio time Pac,a)i) test Direct $oss test
⇒
Test .or $i0uids or l!u!d preparat!on -ollow!ng tet are per-ormed Descriptio Wei)ht +ariatio Ideti7catio test Viscosit# p8 %ssa# Cap sea$i)
33
INSTRUMENTS IN 74C DEPARTMENT: Die$e#t i#st$*!e#ts a$e *se '$ testi#- i# J.C de%a$t!e#t= / / / / / / / / / / / / / / / / / / / /
2'*$ie$ T$a#s'$! I#$a$ed :%et$'%h't'!ete$. UV?visi+le :%et$'%h't'!ete$. Hi-h Pe$'$!a#e Liq*id Ch$'!at'-$a%h". M'ist*$e A#al"e$. A*t'!ati P'la$i!ete$. Diss'l*ti'# A%%a$at*s. Disi#te-$ati'# Test A%%a$at*s. Thi# La"e$ Ch$'!at'-$a%h". H't Plate Ma-#eti :ti$$e$. Vis'!ete$. :'#iati'# ,ath. Melti#- P'i#t A%%a$at*s. Re$at'!ete$. 2$ia+ilit" A%%a$at*s. Va**! P*!% 2ilt$ati'# Asse!+l". C''led I#*+at'$. Wate$ ,ath Di-ital. 2'$ed C'#veti'# Ove#. %H !ete$. C'#d*tivit" !ete$.
/ / / /
Ce#t$i*-e Mahi#e. Dead Wei-hts. A#al"tial ,ala#e. Desiat'$s
/
At'!i A+s'$%ti'# :%et$'%h't'!ete$ .
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7UALITY ASSURANCE DEPARTMENT: J*alit" Ass*$a#e (J.A) is the s*! t'tal ' '$-a#ied a$$a#-e!e#ts !ade &ith the '+1et ' e#s*$i#- that %$'d*t &ill +e ' the q*alit" $eq*i$ed +" thei$ i#te#ded *se. J*alit" ass*$a#e is the s"ste!ati !'#it'$i#- a#d eval*ati'# ' the va$i'*s as%ets ' a %$'1et9 se$vie '$ ailit" t' !ai!ie the %$'+a+ilit" that !i#i!*! sta#da$ds ' q*alit" a$e +ei#- attai#ed +" the %$'d*ti'# %$'ess . JA a##'t a+s'l*tel" -*a$a#tee the %$'d*ti'# ' q*alit" %$'d*ts. I# ENVOY9 the$e &as a %ha$!aist t' !ai#tai# the $elia+ilit" at eve$" sta-e ' !a#*at*$i#- %$'ess sta$ti#- $'! Resea$h9 Cli#ial st*dies9 J*alit" C'#t$'l9 P$'d*ti'#9 Dist$i+*ti'# a#d %$'vides i#'$!ati'# '# a%%$'%$iate *se9 a#d a#al"es saet" a#d i#'$!ati'# ' the %$'d*ts. This de%a$t!e#t assists i# the st$ate-i di$eti'# a#d devel'%!e#t ' J*alit" :"ste!s9 sta#da$d '%e$ati#- %$'ed*$es a#d d'*!e#t '#t$'l %$'-$a!s9 t' e#s*$e &ith the '!%a#" %'liies a#d $e-*lat'$" $eq*i$e!e#t.
R'le ' J*alit" Ass*$a#e i# i#d*st$" • • •
• • • • • • • • • •
Temperature $he$% Lum!d!t' $he$%!ng 4!ne $learan$e Hat d!,erent tage8 !n l!ne $learan$e our -o$u ! on $leanl!ne proper !dent!$at!on o- produ$t bat$h No" pa$%!ng pro$edure8 produ$t label!ng Stab!l!t' tet!ng a!nta!n re$ord D!pat$h tet!ng Landl!ng o- mar%et $ompla!n D!pen!ng $he$%!ng In;pro$e tet!ng SO+ de!gn!ng 9or%er tra!n!ng )al!dat!on Sel- !npe$t!on = !nternal aud!t
35
• •
Art wor% ar%et return
I:process test .or Tab$ets "? per-orm -ollow!ng tet -or !n;pro$e tet!ng o- tablet • •
• • • • • • •
Appearan$e H$olor8 !.e8 hape 9t" #ar!at!on B0 mg o PQ 10 B0 250 mg Q<"5 250mg Q 5 A#erage wt" D!!ntegrat!on Lardne Th!$%ne D!ameter D!olut!on t!me r!ab!l!t' tet 9t" be-ore A 9t" a-ter F x =
A − B X 100 A
I:process test .or Capsu$e • • • •
+h'!$al appearan$e D!!ntegrat!on tet A#erage wt" 9t" #ar!at!on 350 mg or PQ 10
37
350 mg or PQ <"5
I:process test .or *i0uid Preparatio • • •
pL )!$o!t' 9e!ght per ml 9t" o- empt' p'$hno;meter A 9t" o- p'$hno;meter l!u!d= upen!on F 9t o- l!u!d= upen!on F A ? Wt . / ml =
•
C 25
Del!#erable #olume
RESEARCH & DEVELOPMENT DEPARTMENT: ENVOY Pha$!ae*tials has dediated $esea$h tea!s at +'th #ati'#al a#d i#te$#ati'#al level. Thei$ R0D tea! has all the #eessa$" sills a#d eq*i%!e#t t' '$!*late a#d %$'d*e eve# *#iq*e a#d #e& '!+i#ati'#s ' !edii#e. The$e is a R0D de%a$t!e#t i# ENOY &hih &'$ed i# dis've$i#- #e& #'&led-e a+'*t %$'d*ts9 %$'esses9 a#d se$vies a#d the# a%%l"i#- that #'&led-e t' $eate #e& a#d i!%$'ved %$'d*ts9 %$'esses a#d se$vies that ill !a$et #eeds. The" *sed 'll'&i#- a%%a$at*s= / / / / /
5 I# < a%%a$at*s(DTDI:2R). Al*!i#*! 'il seali#- !ahi#e. Ma#*al 'i#t!e#t illi#- !ahi#e. :*-a$ 'ati#- !ahi#e. C'#e !ie$ .
3<
FINISH GOOD STORE: 2i#ished %$'d*ts a$e st'$ed i# this a$ea. Te!%e$at*$e a#d h*!idit" is '#t$'lled he$e t' ass*$e sta+ilit" a#d eetive#ess ' %$'d*ts. P$'d*ts that $eq*i$e 'ld st'$a-e a$e st'$ed i# $e$i-e$at'$. 2i#ished -''d $eeived $e%'$t is als' si-#ed. Ate$ %assi#- J.C tests9 q*alit" %$'d*ts ate$ !a#*at*$i#- a#d %ai#- a$e e%t he$e.A#d the# %$'d*ts a$e s*%%lied t' die$e#t i#stit*tes et. T'da" ENVOY Pha$!ae*tials (Pvt) Ltd. %$'d*ts a$e +ei#- %$'!'ted 0 s'ld i# va$i'*s '*#t$ies a$'*#d the -l'+e .
DISCUSSION:
ENVOY Pha$!ae*tial e#ha#ed *#de$sta#di#- ' !" aade!i #'&led-e a#d sills. It i#deed %'lished !" #'&led-e a#d e%e$ie#e. Class$''! st*dies a$e '#i#ed '#l" t' +''s a#d the'$etial lea$#i#- !a1'$l". A%%liati'# ' these the'$ies a#d let*$es delive$ed i# lass$''!s die$ a little $'! the s%eiiall" set '$!at. Th$'*-h this i#te$#shi%9 I #'t '#l" -'t the '%%'$t*#it" t' e%e$ie#e +*t I als' lea$#t the a%%liati'#s ' these the'$ies i# at*al the a%%liati'#. I -'t t' '+se$ve the &h'le &'$i#- e#vi$'#!e#t ' %ha$!ae*tial i#d*st$" 0 the i!%'$ta#t as%ets $e-a$di#- the %$'d*ti'# ' hi-h q*alit" %ha$!ae*tials 0 a$$"i#- '*t i!%'$ta#t q*alit" '#t$'l tests t' e#s*$e that all the %$'ed*$es a$$ied '*t d*$i# %$'d*ti'# a$e a'$di#- t' MP. I &as a+le t' *#de$sta#d the &'$i#- '#diti'#s ' %ha$!ae*tial i#d*st$" i# Paista#i i$*!sta#es !*h +ette$ tha# +e'$e. It als' i!%$'ved !" -e#e$al #'&led-e a+'*t eq*i%!e#ts '!!'#l" *sed i# '*$ i#d*st$ies. N't '#l" %ha$!aists i# %$'d*ti'# a$eas +*t eve# &'$e$s hel%ed !e t' *#de$sta#d i!%'$ta#t %$'ed*$es $e-a$di#- the %$'d*ti'#. The e#ti$e 1'*$#e" '
3B
i#te$#shi% all'&ed !e t' ide#ti" !" st$e#-ths a#d &ea#esses9 a#d *se +'th ' the! t' the +est adva#ta-e ' !" a$ee$.
Ne)ati+e poits There ! no negat!#e po!nt !n m' ober#at!on !n m' t!me o!nternh!p !n (N)O*" 9or%er> Un!-orm hould be new and the!r $olor hould not -aded" !ndoor hoe are tr!$tl' proh!b!ted out!de the plant"
CONCLUSION & RECOMMENDATIONS
CONCLUSION: Th'*-h se$vi#- '# h*!a#it" is #'t '#l" a %e$s'#s $es%'#si+ilit" +*t als' ' '!!*#it". A#d this '!!*#it" '!%$ises ' all the !e!+e$s sta$ti#- $'! the ve$" i$st ' dis%'sal ' q*alit" %$'d*ts. N' &'$ is %e##iless $athe$ the #'&led-e it ee%s i#9 i#te$#shi% at a#" &'$i#- a$ea is a -$eat lea$#i#- e%e$ie#e i# itsel. RECOMMENDATIONS: I $e'!!e#d is that9 &ith'*t *ll" eq*i%%ed i#stit*tes as &ell as q*aliied a#d dev'ted %e$s'#als9 the %$'essi'# ' !edii#es &ill #'t l'*$ish i# a devel'%i#'*#t$" lie Paista#. I hi-h %a"i#- a$ee$s '#ti#*e t' att$at the +est a#d +$i-htest st*de#ts '*t ' '*#t$"9 the$e &ill #'t '#l" +e a sh'$ta-e ' %$'essi'#als i# '*$ %lae9 +*t the %$'essi'#als availa+le !a" #'t have the +est q*aliiati'#s. The$e'$e9 it is #eessa$" t' %$'vide the +est ' ailities t' the health %$'essi'#als es%eiall" the %ha$!aists +ea*se the" %la" a vital $'le i# e#s*$i#- health.
