Gmp eudralex vol 4 annex 1 July 8, 2019 16 32 64 128 Eudralex vol 4 gmp annex 13 Gmp vol 4 eudralex Eudralex volume 4 annex 19 Eudralex volume 4 annex 1 manufacture of sterile products Gmp vol 4 annex 1