EMA: Guidance on GMP and GDP – New Q&As – Remote batch certification / confirmation and QP’s residency

The EMA published 4 new questions and answers on the guidance on good manufacturing practice and good distribution practice.

These three new questions and answers apply to EU/EEA QP certification or QP confirmation, as described in EU GMP, and specifically in Annex 16. It is applicable to the manufacture and importation of human and veterinary medicinal products as well as investigational medicinal products…