Revista Farmespaña Industrial Julio-Agosto 2023

Air flow smoke pattern testing: nuevo desafío de un test subjetivo en el Anexo 1 Eu GMP Nueva definición en el Anexo 1 EU GMP en vigor desde el 25 de agosto de 2023, un año después de la publicación en Eudralex Volumen 4, excepto el punto 8.123 que será en 2025 FERNANDO ARTOLOZÁBAL CuStOMER SERVICE MANAGER QuALIFICAtION & VALIdAtION EN tELStAR. (WbO]PLRRUVW !-#}K)0#4-2\#%12u$#,'&&$0"#&$%&)"B}#($1/$%&0'# ./$#$-#4-/H2#($#')0$#($"&02#($#/"'#)"%&'-'*)+"# ($#,02*$%'1)$"&2#'%;,&)*2#($?$#($#%$0#/")> ()0$**)2"'-8#($%*$"($"&$#@#./$#"2#%$'#&/0?/> -$"&2<#M'0'#./$# %$'#/"'#,0/$?'#2# $9)($"*)'# *2"&0'%&'('#%$#($?$#($#B0'?'0#$"#9)($2#,'0'# ,02*$($0#'#-'#9)%/'-)A'*)+"#($-#4-/H2< !%&$# &$%&#',-)*'#'# -2%# 4-/H2%# -'1)"'0$%# cIK3d8# *'?)"'%# ($# %$B/0)('(# ?)2-+B)*'# cO^Sd8# ')%-'> (20$%# cSKEd8# 4-/H2%#12(/-'0$%# cjU3Od„R2(2%# $%&2%#$./),2%# &)$"$"#/"#()4/%20# *2"#/"# 4)-&02# i!MK#$"#$-#./$#%$#,02@$*&'#$-#4-/H2#($#')0$#($# 4201'#($%*$"($"&$<#!%&$#4-/H2#)1,'*&'#$"#-2%# ()4$0$"&$%#,02*$%2%#2#,'0&$%#./$#$%&$12%#&0'> ?'H'"(2V# %2?0$# -2%# B/'"&$%# ($# /"# 2,$0'(208# %2?0$# -'%# 'B/H'%# ($# --$"'(2# ($# /"2%# 9)'-$%8# %2?0$#-2%#9)'-$%#*2"#$-#,02(/*&2#'?)$0&2„ *Ub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lME—%# ($# ,'0'('# ($# ,02(/**)+"8# C20'%# "2# ,02(/*&)9'%#($-#,$0%2"'-#($#-'?20'&20)28#*2"> %/12#$"$0B;&)*28#$"&0$#2&02%8#('"#9'-20$%#"2# ($%$'(2%<#^$#&0'&'#($#$9)&'0#$%&'#%)&/'*)+"< *]SLRUVW !"#$%&$#*'%28#%$#($4)")+#/"#,-'"#($#$H$*/*)+"# $"# $-#./$# %$# 9'-20'02"# -2%#()4$0$"&$%#'%,$*> &2%# ./$# ,2(:'"# )"4-/)0# $"# $-# 9)($2# 4)"'-<# !-# ,-'"# *2"%)%&)+# $"# ($4)")0# -2%# ,/"&2%# *0:&)*2%# c'"J-)%)%#($#0)$%B2%d#($#-'%#)"%&'-'*)2"$%#c%'> -'%# ?-'"*'%# @# $./),2%d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b] !-#,0)1$0#0$&2#%$#*$"&0'#$"#-'#($4)")*)+"#($&'> --'('#($#-'#$%&0'&$B)'#($-#{*+12}#%$#$H$*/&'0J# $-# &$%&#,20#,'0&$#($-# -'?20'&20)28#'($1J%#($# 0$9)%'0# $-# '"J-)%)%# ($# 0)$%B2%# ($# -2%# $./),2%# ,'0'#*21,02?'0#$-#,02*$()1)$"&2#($#$H$*/> *)+"# ($-# &$%&# $"# $%&2%# ,/"&2%# *0:&)*2%# c,/$0> &'%8#B/'"&$%8# A2"'#(2%)4)*'*)+"„d8#,0'*&)*'%# '%;,&)*'%#($-#,$0%2"'-8# &)$1,2%#($#,'0'('%# ($#,02(/**)+"„ !-# '"J-)%)%# ($# 0)$%B2%# ,/$($# 0$(/*)0# -2%# &)$1,2%#($-#&$%&#@'#./$#%2-2#%$#,2"$#$-#'*$"> &2# $"# -2%# ,/"&2%# *0:&)*2%# $-)1)"'"(2# B0'?'> *)2"$%# )""$*$%'0)'%<# !-# -'?20'&20)28# $"# $%&$# *'%28# -2# &$":'# ?)$"# 0$'-)A'(28# -2# ./$# B$"$0+# /"#"2&'?-$#'C2002#($#&)$1,2<#c!-#"/$92#'"$> G2#Z#)"()*'#$-#'"J-)%)%#($#0)$%B2%#@#-2#($4)"$d< !-# &$%&#($?$# 0$,02(/*)0# $-#,02*$%2#($#,02> (/**)+"# @]2#1'"),/-'*)+"# ($-# ,02(/*&2# $%> &;0)-# '?)$0&2# @# $"# *2"&'*&2# *2"# -'# '&12%4$0'# ./$#-$#02($'#($"&02#($#/"#P0'(2#K#cK"$G2#Zd<# K#()4$0$"*)'#($#-2#$%&'?-$*)(2#C'%&'#-'#$"&0'> ('#$"#9)B20#($-#K"$G2#Z8#./$#2?-)B'?'# &$"$0# -'#%'-'#$"#P0'(2#K8# -'#"$*$%)('(#($#$H$*/&'0# $-#&$%&#%$#*)0*/"%*0)?$#$%&0)*&'1$"&$#'#-'#A2"'# ($#&0'?'H2#*2"#$-#,02(/*&2#1$()'"&$#/"#4-/H2# -'1)"'0#./$#'*&='#?'H2#*2"()*)2"$%#($#P0'> (2#K#'/"./$#%/#/?)*'*)+"#%$'#$"#/"'#%'-'#($# P0'(2# O<# L"'# "/$9'# *2"()*)+"# ./$# %/,2"$# /"# B0'"# 'C2002# $"$0B;&)*28# 1'@20# 4'*)-)('(# ,'0'#*2"&02-'0#/"'#A2"'#'-#%$0#($#&'1'D2#)"> aneXo i 164 FARMESPAÑA INDUSTRIAL · JUL/AGO 23 Ejemplo direccionalidad de flujo de aire, en la que se observa flujo Grado A / ISO 5.