Annex 16 eudralex volume 4 July 8, 2019 16 32 64 128 Eudralex volume 4 annex 16 certification by a qualified person and batch release Eudralex volume 4 gmp annex 16 Eudralex volume 4 part 1 annex 16 Annex 16 Annex 16 gmp eudralex