PHAR 3 LEC CHAPTER 15 PHAR 6 LEC CGMP PART 3

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PHARDOSE LEC CHAPTER 15: PARENTERALS

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MANUF LEC

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CGMP PART 3: STERILE PRODUCTS 

Injectons  

Ser!e" #$ro%en&'ree #re#(r(tons nen)e) o *e ()+nsere) #(rener(!!$ H$#o) H$#o)er+ er+c c +or#, +or#,ne ne so!-to so!-ton: n: e(r!e e(r!es s njec(*!e )r-%

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P(rener(!s     

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P(r(: O-s)e Eneron: Inestne Denoes ro-es o' ()+nsr(ton ()+nsr(ton o,er ,(n ,e or(! ro-e Injec(*!e ro-es o' ()+nsr(ton Use) .,en (#) )r-% )r-% (cton s )esr esre e)  R(#) /e+er%ences0 s -ncoo#er(te"  P(ten -nconsco-s  Dr-% s ne2ecte *$ o,er ro-es

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P$ro%ens  

(cer(! en)oo4ns Or%( Or%(n ncc +e( +e(*o *o! !e ess s,e) s,e) 'ro+ 'ro+ %r(+ %r(+&& ne%(te *(cer( .,c, c(n c(-se 'eer (n) ,$#oenson

Inr(+-sc-!(r Ro-e 

P(rener(! Ro-es o' A)+nsr(ton Inr(eno-s /I0 Inr(+-sc-!(r /IM0 Inr( r()er )er+(! /ID0 ID0 or Inr(c-(neo-s H$#o)er+c or S-*c-(neo-s /SC" S70 Inr(&(rtc-!(r Inr(s$no(! Inr(,ec(! Inr(s#n(! Inr(&(rer(! Inr(c(r)(c Inr(eno-s Ro-e

en M-sc!e Ino ,e s6n

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Un)er ,e s6n 8ons 8on 9-) (re( S#n(! 9-) S#ne Arer$ He(r

Po#-!(r Is  N(C!  G!-cose A)(n(%es  Pro)e r(#) (cton  L'es(n% n e+er%ences Ds()(n(%e Once ( )r-% )r-% s ()+ ()+n ns ser ere) e)""   Once c(nno *e reree) Src (se#tc #rec(-tons +-s *e (6en ( (!! t+es o (o) rs6 o' n'ecton  S$rn%es (n) nee)!es (re ser!e)  Pon o' enr(nce s )sn'ece) es !oc(tons 'or ()+nsr(ton (s!c c (n) (n) ce#,( ce#,(!c !c ens ens on ,e  (s! *(c6 o' ,e ,(n)  Dors(! 'ore(r+ No #re'erre) !oc(ton 'or ()+nsr(ton Anecc-* *( (!! en en:: ,%, ,%, rs6 rs6 'or  Ane e4r((s(ton E)ence o' #ro#er #!(ce+en  (c69o. o' *!oo) no ,e ()+nsr(ton se I 9-)s  F!o. r(e: ;<&15= +L>, crc-!(tn% *!oo)  M-s +4 ., ,e crc-!(tn% (n) no #rec#(e 'ro+ so!-ton I nee)!e nee)!ess (n) c(,e c(,ee ers rs:: ,ro+* ,ro+*-s -s (n) e+*o!-s 'or+(ton T,ro+*o+*-s: s: *!oo *!oo) ) c!o c!o 'or+ or+e)  T,r .,n ,e *!oo) esse!  E+*o!-s: crc-!(tn% ,ro+*-s  E+*o!s+: *!oc6(%e *!oc6(%e or occ!-son o'  crc-!(ton )-e o e+*o!-s

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Pro)e e2ecs ,( (re !ess r(#) *- (re !on%&!(s !on%&!(stn% tn% ,(n ,ose o*(ne) o*(ne) 'ro+ I ()+nsr(ton (re) r(es o' (*sor#ton So!-ton ?  More r(#)!$ (*sor*e): So!-ton S-s#enson r(#)!$ (*sor*e) (*sor*e):: A@-eo-s A@-eo-s  More r(#)!$ #re#(r(ton ? O!e(%no-s #re#(r(ton Per'or+e) )ee# no ,e s6e!e(! +-sc!es  S,o-!) *e (s '(r (s #oss*!e 'ro+ +(jor neres (n) *!oo) esse!s  A)-!s A)-!s:: -##er -##er o-er o-er @-()r @-()r(n (n o'  %!-e-s +(4+-s

L(core" Ares S 3D&PH B PHAR 3 B PHAR 

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In'(ns (n) $o-n% c,!)ren: )e!o) +-sc!es o' ,e -##er (r+ or +)!(er(! +-sc!es o' ,e ,%, A)+nsr(ton  &r(c6 ec,n@-e: s6n s #!(ce) !(er(!!$ #ror o njecton" ,en ,e nee)!e s nsere)" (s#r(e s!%,!$ o o*sere (n$ *!oo) enern% ,e s$rn%e" ,en n(!!$ njec  G!-e(! re%on: 5 +L  De!o): < +L Pro*!e+s enco-nere):  Ne-r(! )(+(%e  A*scess  C$s  E+*o!s+  He+(o+(  S!o-%,n% o' ,e s6n  Sc(rrn%

Oc(! T$#es o' Injectons 1 <

3

; 5

Injecton  !@-) #re#(r(tons ,( (re )r-% s-*s(nces or so!-tons For njecton  )r$ so!)s ,(" -#on ())ton o' s-(*!e e,c!es" $e!) so!-tons con'or+n% n (!! (s#ecs o ,e re@-re+ens 'or njectons Injec(*!e e+-!son  !@-) #re#(r(ton o'  )r-% s-*s(nce )sso!e) or )s#erse) n ( s-(*!e e+-!son +e)-+ Injec(*!e s-s#enson  !@-) #re#(r(ton o'  so!) s-s#en)e) n ( s-(*!e !@-) +e)-+ For njec(*!e s-s#enson  )r$ so!)s ,(" -#on ())ton o' s-(*!e e,c!e" $e!) #re#(r(tons con'or+n% n (!! (s#ecs o ,e re@-re+ens 'or njec(*!e s-s#ensons

Re#osor$ or )e#o njectons  !on%&(ctn% njectons

S-*c-(neo-s Ro-e 

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For njectons o' s+(!! (+o-ns o'  +e)c(ton  M(4+-+ (+o-n: 13 +L  A+o-ns o' %re(er ,(n < +L: #(n'-! #ress-re Injecton  3 +L s$rn%es  <;& o <&%(-%e nee)!es A)+nsr(ton  Loose nerstt(! tss-e o' ,e -##er (r+" (neror ,%," or !o.er (*)o+en  Se o' njecton s ro(e) Pro*!e+s enco-nere)  Co++on o s6n&rr(tn% )r-%s (n) ,c6 s-s#ensons  In)-r(ton  A*scess  S!o-%,n%

So!ens (n) e,c!es 'or Injectons (er 'or Injecton" USP  

Mos 're@-en!$ -se) so!en (er s #-re) *$ )st!!(ton or *$ reerse

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os+oss No re@-re) o *e ser!e *-  +-s *e

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#$ro%en&'ree For +(n-'(c-re o' njec(*!e #ro)-cs o

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co!!ecton P-r'e) (er" USP 

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Injece) o ,e cor-+ /(sc-!(r !($er o' ,e s6n j-s *e!o. ,e e#)er+s0 A)+nsr(ton  Aneror 'ore(r+ Injecton  <3& o <&%(-%e nee)!e  Insere) ,oron(!!$ o ,e s6n ., ,e *ee! '(cn% -#  On!$ =1 +L s ()+nsere)

No +ore ,(n 1 +%>1== +L (er 'or Injecton" USP

Inr()er+(! Ro-e 

*e ser!e) (Jer #re#(r(ton Sore) n t%, con(ners Inen)e) o *e -se) .,n <; ,o-rs (Jer

Ser!e (er 'or Injecton" USP    

P(c6(%e) n sn%!e&)ose con(ner no !(r%er ,(n 1 L M-s *e #$ro%en&'ree En)oo4n !ee!: K =<5 USP EU>+L Con(n s!%,!$ +ore o(! !e(c,n% o' so!)s 'ro+

,e

%!(ss&!ne)

(n6s

)-rn%

ser!(ton

L(core" Ares S 3D&PH B PHAR 3 B PHAR 

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Use) (s ( so!en" e,c!e" or )!-en 'or

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(!re()$ ser!e) (n) #(c6(%e) njec(*!e 

+e)c(tons (ceros(tc (er 'or Injecton" USP 

+-!t#!e&)ose (!s M-s *e -se) on!$ n #(rener(!s ,( (re

L(c(e) Rn%ers Injecton" USP  

()+nsere) n s+(!! o!-+es  I' +ore ,(n 5 +L o' so!en s re@-re): -se Ser!e (er 'or  

.(er 'or njecton Uses  e,c!e 'or o,er )r-%s  E!ecro!$e re#!ens,er  P!(s+( e4#(n)er

Ser!e .(er 'or njecton con(nn% one or +ore s-(*!e (nt+cro*(! (%ens  (ceros(tc (%en: 9e4*!$ 'or

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Ser!e so!-ton o' N(C!" C!" (n) C(C!< n

Injecton" USP P(c6(%e) n #re!!e) s-rn%es or n (!s con(nn% no +ore ,(n 3= +L L(*e!n% (n) #ortons  N(+es

o'  

Con(ns N(C!" C!" C(C!<" (n) N( !(c(e Uses  F!-) (n) e!ecro!$e re#!ens,er  S$se+c (!6(!ner

Ser!e (er 'or In,(!(ton" USP  

P-re) *$ )st!!(ton or reerse os+oss Ren)ere) ser!e ., no (nt+cro*(!

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(%ens No 'or #(rener(! ()+nsr(ton or o,er

(nt+cro*(! (%ens  NOT FOR USE IN NEONATES

ser!e )os(%e 'or+s Ser!e (er 'or Irr%(ton" USP

So)-+ C,!or)e Injecton" USP  

Ser!e soonc so!-ton o' N(C! n .(er 'or



njecton No (nt+cro*(!

(%ens

*-

,(s

Ser!e) (n) s-(*!$ #(c6(%e) ., no (nt+cro*(! (%en or o,er s-s*(nces

Non(@-eo-s e,c!es

(##ro4+(e!$ 15; +E@ e(c, o' N( (n) C! 

ons #er !er Uses  So!en or e,c!e n so!-tons or

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s-s#ensons o' )r-%s 'or #(rener(! ()+nsr(ton  C(,eer or I !ne 9-s, o nse 9-)s (n) +e)c(tons o +(n(n

1= C  M-s no con(n +ner(! o! or

#(enc$

#(r(n (s ,ese +(er(!s (re no

(ceros(tc So)-+ C,!or)e Injecton" USP

(*sor*e) *$ *o)$ tss-es

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Ser!e soonc so!-ton o' N(C! n .(er 'or





njecton Con(ns one or +ore s-(*!e (nt+cro*(!



 

(%ens P(c6(%e) n con(ners no +ore ,(n 3= +L Use) o 9-s, ( c(,eer or I !ne o

F4e) e%e(*!e o!s  Co++on!$ -se) o Corn o! o Coonsee) o! o Pe(n- o! o Ses(+e o!  M-s re+(n c!e(r .,en coo!e) o

   

G!$cern Pro#$!ene %!$co! A!co,o! E,$! o!e(e Iso#ro#$! +$rs(e D+e,$!(ce(+)e

+(n(n #(enc$ Rn%ers So!-ton" USP

A))e) S-*s(nces Ant'-n%(!>Ant*(cer(! Preser(tes

L(core" Ares S 3D&PH B PHAR 3 B PHAR 

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

M-s *e #resen n ()e@-(e concenr(ton ( ,e t+e o' -se o #reen +-!t#!c(ton

  

o' +croor%(ns+s Merc-r$ (n) c(tonn s-r'(c(ns: ==1 C,o!or*-(no!" creso!" #,eno!: =5 S-!'-r )o4)e or s-!e" *-s-!e"

'or+% !(*or(or$ sr(ns o' E co! 3

(n) reco+*n(n DNA ec,no!o%$ Ls#ro Ins-!n So!-ton  Consss o' nc ns-!n !s#ro cr$s(!s

+e(*os-!e: =< 

Anto4)(ns   

re(cton C,e!(tn%



c((!$s o (cce!er(e o4$%en Nro%en (n) c(r*on )o4)e: )s#!(ce

(%en:

'or+s

co+#!e4

;

5

M(n(n re@-re) #H Prnc#(! *-2er s$se+  Ace(e  Cr(e  P,os#,(e

Saccharomyces

n

(@-eo-s

e,c!e *-2ere) ., D*(sc N( 

P,os#,(e o #H 1&; Iso#,(ne Ins-!n S-s#enson (n) Ins-!n Injecton

S+(!! o!-+e P(rener(!s



Ins-!n Pre#(r(tons



'ro+

(ctn%



Pre+4e) 'or+(ton o' so#,(ne ns-!n

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c!e(r

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