国内へのPIC/S GDP導入を見据えた 当社でのGDP対 …

1 PIC/ s gdp GDP 2017 9 1 5 2017 GMP 1 Contents GDP GDP 2 Contents GDP GDP 3 GDP PIC/S GMP 2012 2 PIC/S 2014 7 GDP 2015 3 PIC/ s gdp 2015 9 PIC/ s gdp GDP GDP 2016 4 PIC/ s gdp GDP 2017 3 6 PIC/ s gdp 2017 GDP PIC/ s gdp PIC/ s gdp 2014 6 PIC/S GMP Annex15 2015 4 4 GDP EU PIC/S EU GDP 2013 3 11 1994 EU-GMP EU-GDP Q&A 2014 3 GDP 2015 3 EU-GMP Annex15 Qualification and Validation 2015 3 PIC/S PIC/ s gdp 2014 6 EU-GDP PIC/S GMP Annex15 2015 4 5 GDP US WHO US USP<1079> Good Storage and Distribution Practices USP USP<1083> Good Distribution Practices Draft GDP

2 WHO Good Distribution Practices for Pharmaceutical Products Annex 5, Technical Report Series, , 2010) WHO GDP Good Storage Practices for Pharmaceuticals Annex 9, Technical Report Series, , 2003) WHO GSP Model guidance for the storage and transport of time- and temperature sensitive pharmaceutical products Annex 9, Technical Report Series, , 2011) Technical supplements to Model guidance for the storage and transport of time- and temperature sensitive pharmaceutical products Annex 5, Technical Report Series, , 2015) 6 PIC/ s gdp GDP 7 PIC/S GMP Annex15

3 8 GMP GDP GMDP GMP GDP CAPA QRM 9 GDP GDP PQS GDP GDP PQS Pharmaceutical Quality System 10 Contents GDP GDP 11 GDP PQS GDP GMP/GQP/GDP GDP GQP GDP PQS GMP PQS ISO9001 PQS GMP 12 GDP GDP PQS PQS 13 GDP 1 2 3 4 5 6 GDP 7 GDP 8

4 9 10 11 12 13 CAPA 14 15 GDP 16 17 18 19 20 21 22 23 24 25 26 27 GDP 28 29 30 31 14 GDP ( ) ( ) GDP PQS PQS PQS SOP 15 PQS GDP ( ) GMP/GQP/GDP CAPA / QRM CSV 16 17 URS DQ OQ PQ

5 CAPA 18 20 C 25 C 40 C 60 C XY XZ YZ ZZ YY 25 C XXX 19 Contents GDP GDP 20 GDP GDP 21 GDP GDP GDP GDP GDP 22 GDP GDP GDP

6 GDP GDP 23 Contents GDP GDP 24 25 Ukima Plant (Tokyo) Utsunomiya Plant (Tochigi) CMO Production facilities Fujieda Plant (Shizuoka) Distribution Centers Distribution Center (Saitama) Distribution Center (Hyogo) 26 (S) (O) S O (D) S O D 6 2 12 2 24 6 4 24 6 144 6 2 12 2 24 RA RA 27 S O S O D (S) (O) S O (D)

7 S O D 6 2 12 2 24 RA RA 28 4t 10t 20t 5 C 20 C 29 4 + 13 2 30 GDP EU-GDP 2013 PIC/ s gdp 2014 PIC/ s gdp GDP GDP PQS GMP/GQP/GDP GDP GDP GDP 31