Current Global GMP Status and Trends With Focus on EU & PIC/S

7 EudraLex Vol 4 (EU – GMP) GMP-Guidelines based on Dir 2003/94/EC and 91/411/EEC (EudraLex Vol. 4: ‘EU-GMP’) Chapter 1-9 ICH Q7 & ICH Q9 principles ICH Q9, ICH Q10, SMF, Batch certificate Annex 1-17;19 GDP guideline; comp. of comm.procedures

www.jpma.or.jp