Transcription of PIC/S GDPガイドライン日本語訳案 ※平成28年度 …
1 1 PIC/S GDP PIC/S GUIDE TO good distribution PRACTICE FOR MEDICINAL PRODUCTS 28 PIC/S GDP 2014 6 4 7 29 29 2 GDP EU (2013/C 343/01) EU PIC/S GDP EU PIC/S PIC/S falsified medicines PIC/S GMP GDP free zone free warehouse customs area free zone free warehouse
2 GDP GDP 3 (IMP) 1 - / i.
3 GDP ii. iii. iv. v. vi. CAPA i. ii. iii. i. ii. CAPA iii. iv. v. 5 EU ICH Q9 2 GDP GDP / )
4 GDP i. ii. iii. iv. v. vi. vii. GDP viii. 6ix. x. xi. xii. GDP GDP 3
5 1 8
6 5 ( ) CAPA CAPA 4 / 5
7 5 i.
8 Ii. iii. iv. 11v. ( ) ( )
9 FEFO 12 / / 6 13 CAPA / i.
10 Ii. 10 iii. iv. v. i. ii. iii. iv. v. vi. vii. FEFO
