Transcription of PIC/S GMP Annex 8全梱包確認試験の課題と事例
1 GMP PIC/S GMP Annex 8 2 PIC/S Annex 8 . 2011 4 1 1430 2016 4 1 PIC/S Annex 8 PIC/S GMP 24 2 1 GMP Part I Annex 8 1 4
2 5 PIC/S Annex 8 PIC/S Annex 8 2 100 100 100 IR 6 1. 2. 3. 2 IR IR IR 14 GMP 2013 7 1.
3 2. 3. IR UV 14 8 ( Annex 8 PIC/S GMP 24 2 1 9)
4 10 GMP GMP GMP ISO 11 A B 12 A / B GMP 2013 13
5 PIC/S GMP 24 2 1 N=1 N ( ) WHO AQL (JIS Z9015 II) n plan p plan r plan 10 1 5 4 2 5 3 10% 50% 40% 20% 50% 30% 100 1 11 11 4 15 20 1% 11% 11% 4% 15% 20% (%) ( ) ( ) ( ) 1 WHO Technical Report Series, No. 929, 2005 Annex4 WHO guidelines for sampling of pharmaceutical products and related materials . IR 16 Annex 8
6 Annex 8 Best Practice
