The European Compliance Academy (ECA) is announcing the revised ECA Good Practice Guide: "FDA cGMP, EU GMP and ISO 9001 Matrix for a pharmaceutical Quality System - A GMP Roadmap".

The Matrices help answer one of the essential questions within the framework of GMP harmonisation: Where exactly are the common traits and differences of EU GMP, US-FDA cGMP und ISO 9001? That is the question asked by globally operating companies that have to implement all three regulations.

The revised ECA Good Practice Guide is a comprehensive juxtaposition containing the requirements laid down in FDA's cGMP Guide, the EU GMP Guide and ISO 9001.

The Revision was necessary to consider the changes and amendments of the EU GMP Guide in the past months and to address the industry demand for the guidance document, e.g.:

1. The second edition contains the EC GMP Guide in the new structure (Part I - Basic Requirements for Medicinal Products and Part II - Basic Requirements for Active Substances used as Starting Materials)
2. EC GMP Guide Part 1 Chapter 1 Quality Management (revision October 2005 including product quality review)
3. EC GMP Guide Part 1 Chapter 6 Quality Control (revision October 2005 including on-going stability
4. EC GMP Guide Part 1 Chapter 8 Complaints and Product Recall (revision December 2005)
5. EC GMP Guide Annex 19 Reference and Retention Samples (December 2005)
6. The Matrix has been changed to comply with the revised EC GMP Guide

The Good Practice Guide contains 2 Matrices:

For globally operating pharmaceutical companies, it is mandatory to fulfil both the requirements of the EU GMP Guide and those of FDA's cGMP Guide. Therefore, the FDA/EU GMP Matrix compares the FDA cGMP Guide with the EU GMP Guideline, taking the first document as a starting point. Here, each paragraph with all its subsections (usually a), b), c) etc.) is considered in order to maximise the informational value.

When publishing the Guidance for Industry "Quality System Approach to Pharmaceutical cGMP" on 29 September 2004, the FDA took requirements from the ISO 9001 document on "Quality Management Systems" into account in the field of pharmaceutical manufacture. The Guide does reference ISO 9001 and include a recommendation; however, the outline does only focus on a partial comparison between the cGMP Guide and ISO 9001. The ISO standard contains additional information on building up quality management systems. In our GMP/ISO 9001 Matrix, each paragraph of the cGMP Guide is linked to the corresponding passage in ISO 9001.

Both Matrices are linked with each other in one document. The following screenshot shows you the structure:

The above-mentioned Matrix is part of the ECA Good Practice Guide: "FDA cGMP, EU GMP and ISO 9001 Matrix for a pharmaceutical Quality System - A GMP Roadmap". The Good Practice Guide includes the Matrix as well as the complete texts of the FDA cGMP Guide (21 CFR 210/211), the EU GMP Guide and ISO 9001.

This Matrix has 20 pages as well as further 390 pages for the three regulations. The regulations have been licensed by the respective organisations.

Please note: The PIC/S Guide included has the same contents as the EC GMP Guide. However, Annex 16 is not integrated, since it has not been passed by PIC/S.

The Matrix can be ordered from ECA for EUR 149 (Non-ECA Members) or EUR 99 (ECA Members). These prices exclude VAT, postage and packing. If you would like to purchase a copy of the GMP Matrix, please click on one of the following links to place an order:

ECA Member         Non-Members

Author:
Daniel Scheidegger,
Genzyme Pharmaceuticals
ECA Chairman