The version 5 of the ECA Good Practice Guide "FDA cGMP, EU GMP and ISO 9001 Matrix for a pharmaceutical Quality System - A GMP Roadmap -" is know available.
The "GMP/ISO Matrix was issued as version 1 back in October 2005. It is intended to support industry and authoritiy 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?
The 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. In addition the Matrix compares both the FDA and the EU GMP Guide with ISO Standard 9001 on Quality Management Systems. With the publication of ICH Q10 "Pharmaceutical Quality System" the requirements laid down in ISO 9001 became more and more important to industry.
The Good Practice Guide includes the above mentioned Matrix as well as the complete texts of the FDA cGMP Guide (21 CFR 210/211), the EU GMP Guide Part 1 and 2 as well as the Draft of Part 3 (including the current Annexes) and the ISO 9001 standard.
The version 5 includes the following changes to the previous version:
1) Annex 13 (coming into operation 31 July 2010) has been included
2) 21 CFR 210 of 1 April 2009 has been included (update of 21 CFR 211 was included in version 4 already)
3) Quality Management Systems - Requirements (ISO 9001:2008) has been included
4) Corrigendum to DIN EN ISO 9001:2008-12 has been included
5) Draft Part I Chapter 1 Quality Management System of 18 November 2009 has been included
6) Draft Part I Chapter 2 Personnel of 18 November 2009 has been included
7) Draft Part III Explanatory notes for pharmaceutical manufacturers on the preparation of a Site Master File and content of a Site Master File of 15 December 2009 has been included
ECA Members receive a copy for a reduced fee of 99,- Euro. The standard fee is 149,- Euro. No further discounts are available because the licence agreement for the ISO 9001 standard requires a payment for every single copy which has been printed. You can order a copy here.
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 improvement or potential extensions to the ECA Secretariat (firstname.lastname@example.org).