GMP Obligations for the Marketing Authorisation Holder

Time: 2:40 pm - 3:00 pm

Date: 29 April 2020

Synopsis

The pharmaceutical manufacturing sector is increasingly working to an outsourced model where the MA Holder is a virtual (office based) entity, without any traditional manufacturing or testing activities on site.
This leads to the false assumption that GMP/GDP do not apply to the MA Holder facility (of course they do).
The EMA have published a reflection paper on GMP for Marketing Authorisation Holders; here are some practical steps an MAH can take to ensure compliance without overloading current systems.

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