21st Edition of the GMP Matrix Published

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?

• The integration of the changes to chapters 3, 5, 6 and 8 of the EU GMP Guidelines in the 16th edition was especially important.
• Integration of Annex 15 in the 17th edition.
• Integration of Annex 16 and integration of ISO 9001 in the edition of 2015 - also in comparison to the edition of 2008 as part of the 18th edition.
• Integration of a matrix comparing ICH Q10 with ISO 9001:2008 and 2015 (18th Edition).
• Integration of EU commisions IMP GMP guideline (21st Edition)

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.