The ECA has published a new guide to illustrate the generally applicable requirements for the design of GMP equipment and to explain how the connection between design and the statement “produced in compliance with GMP” can be made.
It contains numerous references and points of contact, a sort of a road map, that offers detailed information on the requirements or ways of proceeding for individual cases.
The ECA Guide was launched and first published at the ECA Live Online Conference “GMP-Compliant Equipment Design” in November 2022 and can be downloaded free of charge HERE.