New Version of EU GMP FDA cGMP and ISO Matrix Available!

An ECA Working Group has worked on a major revision of the Good Practice Guide which is also well known as FDA/EU-GMP/ISO Matrix. This Matrix compares the FDA cGMP Guide, the EU GMP Guide and ISO 9001. Just recently the ISO standard was completely revised. The new matrix was therefore extended so that it not only comprises a comparison of the old but also of the new ISO 9001 standard with the two GMP Guides. In a previous revision process (Version 16) the new requirements in the EU GMP Guide were incorporated in the matrix - among others the new Chapters of the EU GMP Guide (3,5,6,8).

The new Version 19 contains the following content:

  • 45 pages of the matrix comprising a comparison of the chapters in FDA cGMP Guide, EU GMP Guide, ISO 9001:2008 and ISO 9001:2015
  • 4 pages of a matrix comparing the ICH Q10 Guideline with ISO 9001:2008 and ISO 9001:2015

Please find an excerpt of the matrix below:

USA cGMP EU GMP Guide ISO 9001:2008 ISO 9001:2015
Subpart B -  Organization and Personnel
QCU: Approval/rejection
Testing, production records
211.22a 2.5
2.8-2.9
6.5
7.4 (additional requirement regarding QRM)
4.2.3-4.2.4
7.5.4
7.6
8.2.3-8.2.4
7.5.2, 7.5.3
8.5.3
7.1.5
9.1.1, 8.6
Adequate laboratory facility 211.22b 3.26-3.29
6.5
6.3-6.4
7.6
7.1.3, 7.1.4
7.1.5
QCU: Approval/rejection of procedures/specifications 211.22c 1.4 xv
1.9 vii
2.8
4.27,(QP mentioned)
(5.64)
4.2.3-4.2.4
7.5.3
8.2.3-8.2.4
7.5.2, 7.5.3
8.5.2
9.1.1, 8.6
Written procedures and responsibilities of QCU 211.22d 1.1
1.3
(1.4)
(1.5 Senior Management explicitly mentioned)
1.7 (additional requirement regarding Quality Manual)
(1.9 vii)
2.5-2.62.8
(4.27, QP mentioned)
6.2
4.1
4.2.1
4.2.3
5.4.2
5.5.1
5.5.3
6.1
6.2.1-6.2.2
7.1
4.4
7.5.1
7.5.2-7.5.3
6, 6.1, 6.3
5.3
7.4
7.1.1, 7.1.2
7.2, 7.3
8.1

In addition to the matrix the new 19th revision contains the full text of:

  • FDA cGMP Guide (21 CFR 210/211)
  • EU GMP Guide Part I, II, III
  • Annex 1-19 to the EU GMP Guide
  • ISO 9001:2015 Quality Management Systems

The comprehensive document has 571 pages in total. The ISO standard is copyright protected. Therefore the total fee has to consider the licence fee for the ISO standard. However, ECA Members can purchase the document for only 99,- Euro plus VAT and shipping costs (Non-Members 149,- Euro).

The FDA/EU-GMP/ISO Matrix has become the standard document for QA personnel and auditors in many companies. Some companies have ordered more than 100 copies to make sure that every person involved in compliance activities can check the relevant requirements by using the matrix. To purchase the Matrix please use our GMP publication page.

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