GMP News No. 625
17 October 2005
ECA Good Practice Guide "FDA cGMP, EU GMP and ISO 9001 Matrix for a pharmaceutical Quality System - A GMP Roadmap -"
In support of the increasing harmonisation efforts on the part of the medicines authorities and due to the supervisory authorities' stronger orientation towards establishing quality systems, the European Compliance Academy has published two unique GMP Matrices. The Matrices help in solving one of the essential problems 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. For the first time now, there is a Matrix that places these requirements next to each other.
Within half a year, a project group of the European Compliance Academy worked out a comprehensive juxtaposition containing the requirements laid down in FDA's cGMP Guide, the EU GMP Guide and ISO 9001.
1 FDA cGMP/EU GMP Matrix
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.
2 GMP/ISO 9001 Matrix
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 PIC/S GMP Guide (identical with the EU GMP Guide) and ISO 9001.
The ECA invites all interested circles from industry and authorities to contribute to the development of this document. Please send your comments and suggestions for improvements or potential extensions to the ECA Secretariat (info (at) gmp-compliance (dot) org).
This Matrix has 20 pages as well as further 390 pages for the three regulations. The regulations have been licensed by the respective organisations. 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 the GMP Matrix, please click here in order to download a fax form in PDF format.
The European Compliance Academy is organising the GMP Education Course
FDA's New Quality Systems and Risk Approach in Barcelona, Spain, on 10-11 November 2005
One of the lectures deals among others with ECA's Good Practice Guide (comparison GMP/ISO 9001).