Revista Farmespaña Industrial Julio-Agosto 2023

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$"# $-# ,02*$%2# ($%($# ,02(/**)+"<# M20# 2&02# -'(28# &2('# -'# )"4201'*)+"# @# 0$%/-&'(2%# ($# -'# $9'> -/'*)+"#($-#SS^#($?$# 4-/)0# &'1?);"#C'*)'# -2%# ,029$$(20$%8#%$B="#%/#B0'(2#($#'4$*&'*)+"< !-# (2*/1$"&2# SS^# ($?$# %$09)0# ,'0'# ./$# &2(2# $-#,$0%2"'-#($# -'#,-'"&'# *2"# '4$*&'*)+"# PjM# ,/$('# -$$0# @# *21,0$"($0# -'# )"&$0*2> "$G)+"#($#-2%#()4$0$"&$%#$-$1$"&2%#SS^8#,'0'# %/# 1'@20# *2"*)$"*)'# @# *2"2*)1)$"&28# @# '%:# ,0$9$")0#./$#4/&/02%#*'1?)2%#2#$9$"&2%#,/$> ('"#'4$*&'0#"$B'&)9'1$"&$#'-#$%&'(2#($-#*2"> &02-#($#-'#*2"&'1)"'*)+"< ']WRSL[UVW !-# "/$92# '"$G2# Z# $%# /"# ?/$"# 0$*20('&20)2# ,'0'#-'#0$9)%)+"#@#1$H20'#($#-'%#$%&0'&$B)'%#($# *2"&02-#($#-'#*2"&'1)"'*)+"#($"&02#($-#Mr^# @#$-#/%2#($#rfj<#I'#SS^#($?$#%$0#/"#,02*$%2# )&$0'&)928# ./$# ($?$# %$0# '?20('('# ($# 4201'# C2-:%&)*'8#%)$"(2#/"'#C$00'1)$"&'#,'0'#(2&'0# ($#1'@20#*2"2*)1)$"&2#*0:&)*2#($#-2%#,02*$> %2%#,'0'#B'0'"&:'#($#-'#*'-)('(#($-#,02(/*&2# c@#('0#'%:#1$H20#0$%,/$%&'#'#-'%#'/&20)('($%d# @# $"# (2"($# -'# *)$"*)'# ($# -2%# ('&2%# $%# *'('# 9$A#1J%#/"#4'*&20#1J%#0$-$9'"&$#‚ Acrónimos [1] CCS: Contamination Control Strategy [2] PQS: Pharmaceutical Quality System [3] Eu: European union [4] GMP: Good Manufacturing Practices [5] ICH Q9 (R1) Quality Risk Management (January 2023). [6] ICH Q10 Pharmaceutical Quality System (June 2008). [7] CAPA: Acciones correctivas y preventivas [8] CC: Control de cambios [9] QRM: Quality Risk Management [10] QTPP: Quality Target Product Profile [11] IPC: In-process Controls [12] SMF: Site Master File [13] KPI: Key performance indicator [14] RA: Risk Assessment [15] QA: Quality Assurance [16] QC: Quality Control Normativas de referencia • Annex 1 Manufacture of Sterile Medicinal Products (August 2022). • ICH Q10 Pharmaceutical Quality System (June 2008). • ICH Q9 (R1) Quality Risk Management (January 2023). ANEXO I 154 FARMESPAÑA INDUSTRIAL · JUL/AGO 23 Imagen 3: Controles – Evaluación efectividad – Optimización.