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    TITLE 21--FOOD AND DRUGSCHAPTER I--FOOD AND DRUG ADMINISTRATION

    DEPARTMENT OF HEALTH AND HUMAN SERVICESSUBCHAPTER C--DRUGS: GENERAL

    PART 211 CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHEDPHARMACEUTICALS

    Subpart A--General Provisions 211.1- Scope. 211.3- De!"!#!o"$.

    Subpart B--Organization and Personnel 211.22- Re$po"$!%!&!#!e$ o '()&!#* co"#+o& ("!#. 211.2,- Pe+$o""e& '()&!!c)#!o"$.

    211.2- Pe+$o""e& +e$po"$!%!&!#!e$. 211.3- Co"$()"#$.

    Subpart C--Buildings and Facilities 211.2- De$!/" )"0 co"$#+(c#!o" e)#(+e$. 211.- L!/#!"/. 211.- Ve"#!&)#!o" )!+ !+)#!o" )!+ e)#!"/ )"0 coo&!"/. 211.- P&(4%!"/. 211.,5- Se6)/e )"0 +e($e. 211.,2- 7)$!"/ )"0 #o!&e# )c!&!#!e$. 211.,- S)"!#)#!o". 211.,- M)!"#e")"ce.

    Subpart D--Equipment 211.3- E'(!p4e"# 0e$!/" $!8e )"0 &oc)#!o". 211.,- E'(!p4e"# co"$#+(c#!o". 211.9- E'(!p4e"# c&e)"!"/ )"0 4)!"#e")"ce. 211.- A(#o4)#!c 4ec)"!c)& )"0 e&ec#+o"!c e'(!p4e"#. 211.92- F!e+$.

    Subpart E--Control o Components and Drug Product Containers and Closures 211.5- Ge"e+)& +e'(!+e4e"#$. 211.2- Rece!p# )"0 $#o+)/e o ("#e$#e0 co4po"e"#$ 0+(/ p+o0(c# co"#)!"e+$ )"0 c&o$(+e$. 211.- Te$#!"/ )"0 )pp+o)& o+ +e;ec#!o" o co4po"e"#$ 0+(/ p+o0(c# co"#)!"e+$ )"0 c&o$(+e$. 211.- U$e o )pp+oe0 co4po"e"#$ 0+(/ p+o0(c# co"#)!"e+$ )"0 c&o$(+e$. 211.9- Re#e$#!"/ o )pp+oe0 co4po"e"#$ 0+(/ p+o0(c# co"#)!"e+$ )"0 c&o$(+e$.

    211.

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    211.115- S)4p&!"/ )"0 #e$#!"/ o !"-p+oce$$ 4)#e+!)&$ )"0 0+(/ p+o0(c#$. 211.111- T!4e &!4!#)#!o"$ o" p+o0(c#!o". 211.113- Co"#+o& o 4!c+o%!o&o/!c)& co"#)4!")#!o". 211.11,- Rep+oce$$!"/.

    Subpart G--Pac!aging and "abeling Control

    211.122- M)#e+!)&$ e>)4!")#!o" )"0 ($)/e c+!#e+!). 211.12,- L)%e&!"/ !$$()"ce. 211.135- P)c?)/!"/ )"0 &)%e&!"/ ope+)#!o"$. 211.132- T)4pe+-e!0e"# p)c?)/!"/ +e'(!+e4e"#$ o+ oe+-#e-co("#e+ @OTC (4)" 0+(/ p+o0(c#$. 211.13- D+(/ p+o0(c# !"$pec#!o". 211.139- E>p!+)#!o" 0)#!"/.

    Subpart #--#olding and Distribution 211.12- 7)+eo($!"/ p+oce0(+e$. 211.1,5- D!$#+!%(#!o" p+oce0(+e$.

    Subpart $--"aborator% Controls 211.15- Ge"e+)& +e'(!+e4e"#$.

    211.1,- Te$#!"/ )"0 +e&e)$e o+ 0!$#+!%(#!o". 211.1- S#)%!&!#* #e$#!"/. 211.19- Spec!)& #e$#!"/ +e'(!+e4e"#$. 211.195- Re$e+e $)4p&e$. 211.193- L)%o+)#o+* )"!4)&$. 211.19- Pe"!c!&&!" co"#)4!")#!o".

    Subpart &--'ecords and 'eports 211.15- Ge"e+)& +e'(!+e4e"#$. 211.12- E'(!p4e"# c&e)"!"/ )"0 ($e &o/. 211.1- Co4po"e"# 0+(/ p+o0(c# co"#)!"e+ c&o$(+e )"0 &)%e&!"/ +eco+0$. 211.1- M)$#e+ p+o0(c#!o" )"0 co"#+o& +eco+0$. 211.1- B)#c p+o0(c#!o" )"0 co"#+o& +eco+0$.

    211.1

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    Co0e o Fe0e+)& Re/(&)#!o"$

    Subpart A--General Provisions

    TITLE 21--FOOD AND DRUGSCHAPTER I--FOOD AND DRUG ADMINISTRATION

    DEPARTMENT OF HEALTH AND HUMAN SERVICESSUBCHAPTER C--DRUGS: GENERAL

    PART 211 CURRENT GOOD MANUFACTURING PRACTICE FOR

    FINISHED PHARMACEUTICALS

    Sec. 211.1 Scope.@) Te +e/(&)#!o"$ !" #!$ p)+# co"#)!" #e 4!"!4(4 c(++e"# /oo0 4)"()c#(+!"/ p+)c#!ce o+ p+ep)+)#!o" o 0+(/p+o0(c#$ o+ )04!"!$#+)#!o" #o (4)"$ o+ )"!4)&$.@% Te c(++e"# /oo0 4)"()c#(+!"/ p+)c#!ce +e/(&)#!o"$ !" #!$ c)p#e+ )$ #e* pe+#)!" #o 0+(/ p+o0(c#$= !" p)+#$55 #+o(/ 5 o #!$ c)p#e+ )$ #e* pe+#)!" #o 0+(/$ #)# )+e )&$o %!o&o/!c)& p+o0(c#$ o+ (4)" ($e= )"0 !"p)+# 1291 o #!$ c)p#e+ )$ #e* )+e )pp&!c)%&e #o 0+(/$ #)# )+e )&$o (4)" ce&&$ #!$$(e$ )"0 ce&&(&)+ )"0 #!$$(e-%)$e0 p+o0(c#$ @HCTP$ )"0 #)# )+e 0+(/$ @$(%;ec# #o +e!e6 ("0e+ )" )pp&!c)#!o" $(%4!##e0 ("0e+ $ec#!o" ,5,o #e )c# o+ ("0e+ ) %!o&o/!c)& p+o0(c# &!ce"$e )pp&!c)#!o" ("0e+ $ec#!o" 3,1 o #e P(%&!c He) Se+!ce Ac#=

    $(pp&e4e"# )"0 0o "o# $(pe+$e0e #e +e/(&)#!o"$ !" #!$ p)+# ("&e$$ #e +e/(&)#!o"$ e>p&!c!#&* p+o!0e o#e+6!$e. I"#e ee"# o ) co"&!c# %e#6ee" )pp&!c)%&e +e/(&)#!o"$ !" #!$ p)+# )"0 !" o#e+ p)+#$ o #!$ c)p#e+ o+ !" p)+#$ 55#+o(/ 5 o #!$ c)p#e+ o+ !" p)+# 1291 o #!$ c)p#e+ #e +e/(&)#!o" $pec!!c)&&* )pp&!c)%&e #o #e 0+(/ p+o0(c#!" '(e$#!o" $)&& $(pe+$e0e #e 4o+e /e"e+)&.@c Pe"0!"/ co"$!0e+)#!o" o ) p+opo$e0 e>e4p#!o" p(%&!$e0 !" #e Fe0e+)& Re/!$#e+ o Sep#e4%e+ 2

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