Can I read GMP Guidelines for Advanced Therapies on EtoBox?

GMP Guidelines for Advanced Therapies by Ghudhh is a document available to read on EtoBox.

What is GMP Guidelines for Advanced Therapies about?

The document outlines the Guidelines on Good Manufacturing Practice (GMP) specific to Advanced Therapy Medicinal Products (ATMPs), adopted by the European Commission on November 22, 2017, with a compliance deadline of May 22, 2018. It details the mandatory GMP requirements for ATMPs, including risk-based approaches, personnel training, premises, equipment, documentation, production, quality control, and the roles of manufacturers and marketing authorization holders. The guidelines emphasize the importance o

Author

Ghudhh

Language

EN