Area de Elaboracion de Preparados

7/24/2019 Area de Elaboracion de Preparados

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REA DEELABORACIN DE

PREPARADOSMARION VELZQUEZ VILLAFAAMARA ALONDRA HERNNDEZMICHELLE MONTSERRAT GUZMN BARRN


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BUENAS PRACTICAS DE MANUFACTURA DE PROD

BPM son un conun!o "# no$%&s %'n(%&s#s!&)*#c("&s &c#+!&"&s (n!#$n&c(on&*%#n!#,"# c&$-c!#$ o)*(.&!o$(o/

To"o *&)o$&!o$(o 0u# #*&)o$# +$o"uc!os.&*1n(cos "#)# +on#$ #n +$-c!(c& #* s(s!#%&"# c&*("&" 0u# .&$&n!(c# 0u# *os +$o"uc!os+o$ #**os 2&)$(c&"os o2$#3c&n 4 cons#$5#nsus +&$-%#!$os "# c&*("&"/

G&$&n!'& "# *& C&*("&" #s un conun!o "#%#"("&s 0u# s# "#)#n &"o+!&$ +&$&&s#.u$&$ 0u# *os +$o"uc!os .&*1n(cos s#&n"# c&*("&" $#0u#$("&/


3/33

BUENAS PRCTICAS DE MANUFACTURA DE PROD

BUENAS PRCTICAS DE PRODUCCIN6T(#n# co%o o)#!(5o +$(nc(+&* "(s%(nu($ &* %-7(%o *os $(#s.os (n8#$#n!#s & *&+$o"ucc(9n "# +$o"uc!os .&*1n(cos co%o son *& con!&%(n&c(9n c$u3&"& 4 *& con2u

L&s Bu#n&s P$-c!(c&s "# +$o"ucc(9n #7(.#n6

: Qu# *os +$oc#sos #s!1n c*&$&%#n!# "#;n("os con *& c&*("&"

$#0u#$("& cu%+*(#n"o #s+#c(;c&c(on#s/

: R#.(s!$os +&$& "#%os!$&$ 0u# !o"os *os +$oc#"(%(#n!os #

(ns!$ucc(on#s s# cu%+*#n/


4/33


: Qu# s# "(s+on.& "# +#$son&* c&*(;c&"o 4 c&+&c(!&"o,(n2$s!$uc!u$&, #0u(+os 4 %&!#$(&*#s +&$& #2#c!u&$ *os +$oc#s

4 con!$o*#s "# +$o"ucc(9n/

: Qu# s# #s!u"(# !o"& 0u#& con!$& un +$o"uc!o 4 s# (n5#s!(.u#

*&s c&us&s "# un "#2#c!o "# c&*("&"/

: L&s o+#$&c(on#s "# +$o"ucc(9n "#)#n s#.u($ +$oc#"(%(#n!os

c*&$&%#n!# "#;n("os +&$& o)!#n#$ +$o"uc!os 0u# $#


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BUENAS PRACTICAS DE CONTROL DE CALIDAD

E* "#+&$!&%#n!o "# Con!$o* "# C&*("&" "#)# #s!&$ )&o *& &u!o$("&" "# un& +#$son&c&*(;c&"& 4 #7+#$(%#n!&"&/

E* "#+&$!&%#n!o "# Con!$o* "# C&*("&" "#)#6

: Con!&$ con (n2$s!$uc!u$& , (ns!&*&c(on#s 4 #0u(+os &"#cu&"os

con *&s o+#$&c(on#s 0u# #n #**os s# 8&)$-n "# #2#c!u&$/

: Con!&$ con +#$son&* "# #7+#$(#nc(&, conoc(%(#n!os 4

co%+#!#nc(& n#c#s&$(& +&$& *o.$&$ un #2#c!(5o con!$o* "# c&*("&"

#n *& 2&)$(c&c(9n/


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: Con!&$ con +$oc#"(%(#n!os 4 $#.(s!$os "# *os con!$o*#s#2#c!u&"os, "u$&n!# !o"&s *&s #!&+&s "# +$o"ucc(9n/

SANEAMIENTO

E* *&)o$&!o$(o "#)# %&n!#n#$ un #*#5&"o n(5#* "# s&n#&%(#n!o # 8

&)&$c& &* +#$son&*, (ns!&*&c(on#s, #0u(+os, &+&$&!os, $#c(+(#n!#s 4 %+&$& *& +$o"ucc(9n 4 !o"o &0u#**o 0u# +u#"# s#$ 2u#n!# "# con!&%

D#)# #7(s!($ +$oc#"(%(#n!os, +$o.$&%&s "# s&n#&%(#n!o # 8(.(#n# $#.(s!$os "# su cu%+*(%(#n!o/


7/33

Produccin

Control de Calidad reas Auxiliares

Almacenamiento

Pesadas

Servicios higinVestidoresmantenimiento

Comedor

SlidosLquidosSemislidos

MuestreoMaterias primasMaterial de EmpProductos intermProductos graneProductos termi

FisicoqumicoMicrobiolgicoinstrumental

LABORATORIO

FABRIC. PREPARADO

INSTALACIONESFSICAS


8/33

BPM

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L#'$(#"$($ )EC$!"($L )E C#L)#)

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BPM


9/33

PERSONALE* 2&$%&c1u!(co !(#n# $#s+ons&)(*("&" so)$# *&s+$#+&$&c(on#s 0u# s# $#&*(c#n #n su o;c(n& "# 2&$%&c(&o #n *os s#$5(c(os 2&$%&c1u!(cos & su c&$.o6= F&$%&c1u!(co >#2# "# S#$5(c(o6 #s $#s+ons&)*# ;n&*/

= F&$%&c1u!(co $#s+ons&)*# "#* -$#& "# 2&$%&co!#cn(&6#s #* $#s+ons&)*# "($#c!o/= F&$%&c1u!(co $#s("#n!#6 co%o 2&$%&c1u!(co !&%)(1n#s $#s+ons&)*#/

P#$son&* con conoc(%(#n!o, c&+&c(!&c(9n, #7+#$(#nc(&0u# su +u#s!o $#0u(#$&/ D#)# con!&$s# con un

+$o.$&%& "# c&+&c(!&c(9n (n(c(&* 4 con!(nu&?(nc*u4#n"o #* +#$son&* !1cn(co, "# %&n!#n(%(#n!o 4"# *(%+(#3&@/L& +#$son& & *& cu&* s# 5& & &u!o$(3&$ +&$& *& #*&)o$&c(9n

4 con!$o* "# *os +$#+&$&"os +o$ #* 2&$%&c1u!(co "#)#$#c()($ 2o$%&c(9n #s+#c';c& so)$# *&s !1cn(c&s u!(*(3&"&s/S(#%+$# con !u!#*& "# un 2&$%&c1u!(co/ To"o #* +#$son&* "#)# conoc#$ *os +$(nc(+(os "#* +$oc#so "# #*&)o$&c

$#*&c(9n & sus -$#&s/ S# "#)# %o!(5&$ &* +#$son&* 0u# s# #s2u#$c# #n

%&n!#n#$ no$%&s "# c&*("&" &"#cu&"&/


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PREVENIR6

E* &cc#so "# +#$son&s no &u!o$(3&"&s & *&s -$#&s/

To"&s *&s +#$son&s (n5o*uc$&"&s #n *os +$oc#sos "# 2&)$(c&c(9n "#)un &*!o n(5#* "# 8(.(#n# +#$son&*/

PROHIBIRSE6

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Co%#$

A2#c!&n &*& c&*("&"

M&s!(c&

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11/33

O$.&n(3&c(9n "#* +#$son&*

Funciones:F&$%&c1u!(co Es!&)*#c(%(#n!o "# no$%&s

4 %#!o"o*o.'&s ?"#+$#+&$&"os, "# c&*()$&c(9n"# #0u(+os, "# *(%+(#3&, "#%&n!#n(%(#n!o@,#*&)o$&c(9n, con!$o* "#

c&*("&"/ A+$o)&c(9n "#+$oc#"(%(#n!os,"ocu%#n!os, ;c8&s 4+$oc#sos/

Con!$o* "# "ocu%#n!&c(9n"# *os &+&$&!os, 5&*("&$#*&)o$&"os, &c#+!&$ o$#c8&3&$ %&!#$(&s +$(%&s 4%&!#$(&* 0u# s# us#, $#&*(3&$

+#"("os "# %/+/, &n&*(3&$ 4+$o)&$ s( s# o)!(#n#n

T1cn(co

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E*&)o$&$ +$#+&$&"oso;c(n&*#s 4+$#+&$&c(on#s#s!1$(*#s "#;n("&s+o$ #* 2&$%&c1u!(co/

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P$oc#"("# *(%+c&*()$&c#0u(+os%&n!#n"#* -$#&


12/33

ELABORACIN

Inexistencia en elrea de trabajo de:

A*.


13/33

INSTALACIONES

L&s (ns!&*&c(on#s "#)#n s#$ "(s#K&"&s,cons!$u("&s, u)(c&"&s &"&+!&"&s 4%&n!#n("&s &co$"#s & *&s o+#$&c(on#s0u# s# $#&*(3&$-n #n #**&s/

Su+#$;c(#s "# *&s +&$#"#s, +(sos 4!#c8os "#)#n s#$ *(sos, 2-c(*#s "# *(%+(&$/

L&s -$#&s "# +$o"ucc(9n "#)#n !#n#$

-n.u*os s&n(!&$(os, *u%(n&$(&s 2-c(*#s "#*(%+(&$/


14/33

D#)#n "(s+on#$ "# -$#&s #s+#c';c&s 4 s#+&$&"&s +&$& "(2#$#n!#s &c!(5("&"#s 0u# s# $#&*(3&n #n #**&s6

: F&)$(c&c(9n

: En5&s&"o

: Acon"(c(on&"o

: Con!$o* "# C&*("&": A*%&c#n#s

L&s -$#&s "#s!(n&"&s & *& #*&)o$&c(9n "# +$o"uc.&*1n(cos s# "#"(c&$-n #7c*us(5&%#n!# & "(c8o ;n/


15/33

L&s (ns!&*&c(on#s "#)#n !#n#$ un o$"#n *9.(co 4 conco$"&con *& s#cu#nc(& "# *&s o+#$&c(on#s "# +$o"ucc(9n/

D#)# !#n#$ uos "# (n.$#so "# +#$son&* 4 %&!#$(&*#s/

L&s -$#&s "# "#sc&nso 4 $#2$(.#$(o "#)#n #s!&$ 2u#$& "# *-$#&s "# +$o"ucc(9n/

Los 5#s!u&$(os, "uc8&s 4 s#$5(c(os 8(.(1n(cos "#)#n s#$ "2&c(* &cc#so &"#cu&"os &* n


16/33

NAS PRACTICAS DE MANUFACTURA DE PRODUCTOS

/:MATERIAS PRIMAS MATERIAL DEACONDICIONAMIENTO

L&s %&!#$(&s +$(%&s 4 #* %&!#$(&* "#&con"(c(on&%(#n!o s# so*(c(!&$-n &*+$o5##"o$ "# 2o$%&6

"ocu%#n!&"&, s(.u(#n"o #* +$oc#"(%(#n!o"# co%+$&s co$$#s+on"(#n!#

!#n(#n"o #n cu#n!& *& s(s!#%-!(c& "#&+$o5(s(on&%(#n!o 4 +#$(o"(c("&" 8&)(!u&*/


17/33

MATERIAS PRIMAS

En #* %o%#n!o "# *& $#c#+c(9n "# *os +$o"ucon2

(n!#.$("&", &s+#c!o 4 #!(0

A +&$!($ "# #s& &c#+!&c(9n, s# $#.(s!$&$-n 4 s# s"# cu&$#n!#n&, "#)("&%#n!# s#+&$&"& # ("#n!(;

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%&.(s!$&

o;c(n&*#s cu%+*($-n con *os $#0u(s(!os F&$%&co+#

"#2#c!o, con un& 2&$%&co+#& "# $


18/33

MATERIAS PRIMAS

En cu&n!o &* #!(0u#!&"o "# *&s %&!#$(&s +$(%&s &+#$2#

con!#n#$ co%o %'n(%o *

No%)$# "# *& %&!#$(& +$(%&

N


19/33

Los !&**#$#s "# %&n!#n(%(#n!o "#)#n #s!&$ s#+&$&"os "# *&s -$#&+$o"ucc(9n/

ALMACENES

C&+&c("&" su;c(#n!# +&$& &*%&c#n&$ #n 2o$%& o$"#n&"& 4 co$$#c%&!#$(&s +$(%&s, %&!#$(&* "# #%+&0u#, +$o"uc!os & .$&n#* 4!#$%(n&"os/

L(%+(os, %&n!#n("os & con"(c(on#s "# T 4 H/R/ "# &cu#$"o & *os+$o"uc!os & &*%&c#n&$/ Es!&s "#)#n #s!&)*#c#$s#, con!$o*&$s# 4$#.(s!$&$s#/


20/33

D#)# con!&$ con -$#&s s#+&$&"&s +&$&6

: Cu&$#n!#n&

: A+$o)&"os

: R#c8&3&"os

: D#5o*uc(on#s

AREA DE PESADAD#)# #7(s!($ un -$#& "# +#s&"& 0u# +u#"# s#$ +&$!# "#* -$#& "#&*%&c#n&%(#n!o o "#* -$#& "# +$o"ucc(9n/

F*uo "# +#$son&* 4 %&!#$(&*#s


21/33

L&s c&)(n&s "# +#s&"& "#)#n con!&$ con "(s+os(!(5os +&$& con!$o*(!&$ *& con!&%(n&c(9n c$u3&"& 4 2&c(*(!&$ *& *(%+(#3&/

EQUIPOS, ACCESORIOS UTENSILIOS

Los #0u(+os "#)#n u)(c&$s# 4 %&n!#n#$s# "# con2o$%("&" & *&s o+0u# s# 8&)$-n "# $#&*(3&$/

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22/33

*os #0u(+os s# "#)#n 6

: D(s#K&$, cons!$u($, &"&+!&$, u)(c&$ 4

%&n!#n#$ +&$& cu%+*($ con #* uso

+$o+u#s!o/

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*(s&s, s(n ;su$&s o $u.os("&"#s 0u#&*)#$.u#n $#s!os .#n#$&n"o

con!&%(n&c(9n %(c$o)(&n& 4

c$u3&"&/


23/33

D#)#n s#$ s&n(!(3&"os +on(#n"o #s+#c(&* 1n2&s(s #n *& *(%+(#3& "# "# +&so, )o%)&s, co"os "# !u)#$'&/

Los #0u(+os "# +#s&"& # (ns!$u%#n!os "# %#"(c(9n "#)#n !#n#$6

R&n.o "# uso

P$#c(s(9n 4 #7&c!(!u"

C&*()$&"os6: c$ono.$&%& ;o: 5#$(;c&"os: %&n!#n#$ *os $#.(s!$os


24/33

D#)#n s#$ $o!u*&"os s#.


25/33

Los #0u(+os "# +$o"ucc(9n "# &.u& "#)#n .&$&n!(3&$ su c&*("&" 4 *&con2o$%("&" "#* +$o"uc!o !#$%(n&"o/

MATERIALES PRODUCTOS TERMINADOS

To"os *os %&!#$(&*#s 4 +$o"uc!os 0u# (n.$#s&n & *os &*%&c#n#s "#)

so%#!("os & cu&$#n!#n& "#s+u1s "# su $#c#+c(9n 8&s!& s#$ &u!o$(3su uso/

L&s %&!#$(&s +$(%&s "#)#n s#$ "(s+#ns&"&s so*&%#n!# +o$ +#$son&"#s(.n&"&s "# con2o$%("&" con un +$oc#"(%(#n!o #sc$(!o/


26/33


L&s %&!#$(&s +$(%&s &*%&c#n&"&s "#)#n #s!&$ co$$#c!&%#n!# #!(0u

? no%)$#, 2#c8& "# $#c#+c(9n, +$o5##"o$, N "# *o!#, c&n!("&", 2#c8#7+($&c(9n, N 4 2#c8& "# &n-*(s(s, 2#c8& "# $#&n-*(s(s@/

En #* %u#s!$#o 4 +#s&"& "# *&s %&!#$(&s +$(%&s "#)#n !o%&$s#+$#c&uc(on#s +&$& #5(!&$ *& con!&%(n&c(9n c$u3&"&/

Los %&!#$(&*#s (%+$#sos "#)#n .u&$"&$s# #n con"(c(on#s s#.u$&s/

Los +$o"uc!os !#$%(n&"os "#)#n %&n!#n#$s# #n cu&$#n!#n& 8&s!& *()#$&c(9n ;n&*/


27/33

L&s %&!#$(&s +$(%&s &*%&c#n&"&s "#)#n #s!&$ co$$#c!&%#n!# #!(0u

? no%)$#, 2#c8& "# $#c#+c(9n, +$o5##"o$, N "# *o!#, c&n!("&", 2#c8#7+($&c(9n, N 4 2#c8& "# &n-*(s(s, 2#c8& "# $#&n-*(s(s@/

En #* %u#s!$#o 4 +#s&"& "# *&s %&!#$(&s +$(%&s "#)#n !o%&$s#+$#c&uc(on#s +&$& #5(!&$ *& con!&%(n&c(9n c$u3&"&/

Los %&!#$(&*#s (%+$#sos "#)#n .u&$"&$s# #n con"(c(on#s s#.u$&s/

Los +$o"uc!os !#$%(n&"os "#)#n %&n!#n#$s# #n cu&$#n!#n& 8&s!& *()#$&c(9n ;n&*/


28/33


/:DISPENSACION6

#s!&)*#c# 0u# *& "(s+#ns&c(9n "# 29$%u*&s %&.(s!$&*#s 4 +$#+&$&"oo;c(n&*#s s# &us!&$-

& *o "(s+u#s!o #n *& *#.(s*&c(9n 5(.#n!# ?L#4 G#n#$&* "# s&*u"@/

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!$&nsc$(+c(on#s "# *& o$"#n %1"(c& o$(.(n&*, &s' co%o *&s co%un(c&5#$)&*#s/


29/33

DISPENSACION

L&s 29$%u*&s %&.(s!$&*#s 4 +$#+&$&"os o;c(n&*#s s# "(s+#ns&$-n #n #n5&s#n&!u$&*#3& 4 &* uso &* 0u# #s!1n "#s!(n&"os, "# 2o$%& 0u# .&$&n!(c#n *& +$o4 #* %&n!#n(%(#n!o "# *& c&*("&" "#* %(s%o "u$&n!# #* !(#%+o "# 5&*("#3 #2&$%&c1u!(co #*&)o$&"o$/

En #* &c!o "# *& "(s+#ns&c(9n s# "#)# +$o+o$c(on&$ &* +&c(#n!# (n2o$%&c(9n%#"(c&c(9n 0u# "#)# !o%&$ 4 #* $1.(%#n +oso*9.(co/

Los &s+#c!os %'n(%os 0u# "#)# con!#n#$ *& (n2o$%&c(9n "# c&"& %#"(c&%

29$%u*&s %&.(s!$&*#s 4 +$#+&$&"os o;c(n&*#s son *os +$#s#n!#s #n *& #!(0u#con2o$%# &* con!#n("o "# *&s %ono.$&2'&s "#* Fo$%u*&$(o N&c(on&*/


30/33

DISPENSACION

En #* c&so "# 29$%u*&s %&.(s!$&*#s no !(+(;c&"&s s(#%+$# "#)#n "# cons!&

: "&!os "#* s#$5(c(o "# 2&$%&c(& ?no%)$#, "($#cc(9n 4 !#*12ono@

: co%+os(c(9n cu&*(!&!(5& 4 cu&n!(!&!(5& co%+*#!&

: 2o$%& 2&$%&c1u!(c&, "os(s un(!&$(& 4 n


31/33

Los %&!#$(&*#s # (nsu%os $#c8&3&"os "#)#n("#n!(;c&$s# 4 &*%&c#n&$s# s#+&$&"o #n -$#&s$#s!$(n.("&s/

DOC!ENTACION

Los "ocu%#n!os "#)#n s#$ "(s#K&"os, $#5(s&"os4 "(s!$()u("os cu("&"os&%#n!#/

D#)#n s#$ A+$o)&"os, F($%&"os 4 F#c8&"os +o$*&s +#$son&s &u!o$(3&"&s/


32/33

P$o+9s(!o "# *& "ocu%#n!&c(9n6

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As#.u$&$ 0u# !o"o #* +#$son&* conoc#

0u1 8&c#$ 4 cu-n"o 8&c#$*o/

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33/33

Los "ocu%#n!os "#)#n $#5(s&$s# $#.u*&$%#n!# 4 %&n!#n#$s# &c!u&*(3&"o

Los $#.(s!$os "#)#n s#$ #2#c!u&"os o co%+*#!&"os &* %(s%o !(#%+o 0u# s"#s&$$o**&n *&s o+#$&c(on#s/

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