Summary

Annex 1 on Manufacturing of Sterile Medicinal Products, of the Eudralex Volume 4

Annex 1 “Manufacturing Of Sterile Medicinal Products” of the EU GMP Guide was first published in 1971, since then it has undergone a number of targeted updates but, has not undergone a full review. This revision is intended to add clarity, introduce the principles of Quality Risk Management to allow for the inclusion of new technologies and innovative processes, and to change the structure to a more logical flow.

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