06 May 2020
Published in its 21st edition by now, the GMP Matrix has been a recognised standard for GMP auditors or QA units since 2005, and not only in multinational companies. The matrix juxtaposes the US cGMP requirements as per CFR 210/211 with the EU GMP Guidelines and shows commonalities and differences. It also draws parallels to ISO 9001:2008 and 2015.
What has changed in recent years in particular?
Meanwhile, the Matrix has been submitted in its 21st edition (as of January 2018) and is very compact. The GMP Matrix Guide contains the full text of 21 CFR 210/211, the EU GMP Guidelines Part I - IV, including Annexes 1-19, and DIN EN ISO 9001:2015. Thus, the GMP Matrix now comprises 683 pages.
The Matrix is distributed exclusively by the European Compliance Academy.