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GMP News No. 625
17 October 2005
ECA Good Practice Guide"FDA cGMP, EU GMP and ISO 9001Matrix for a pharmaceutical Quality System - A GMP Roadmap -"
In support of the increasing harmonisation efforts on the part ofthe medicines authorities and due to the supervisory authorities' strongerorientation towards establishing quality systems, the European ComplianceAcademy has published two unique GMP Matrices. The Matrices help insolving one of the essential problems within the framework of GMPharmonisation: Where exactly are the common traits and differences of EUGMP, US-FDA cGMP und ISO 9001? That is the question asked by globallyoperating companies that have to implement all three regulations. For thefirst time now, there is a Matrix that places these requirements next toeach other.
Within half a year, a project group of the European Compliance Academyworked out a comprehensive juxtaposition containing the requirements laiddown 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 tofulfil both the requirements of the EU GMP Guide and those of FDA's cGMPGuide. Therefore, the FDA/EU GMP Matrix compares the FDA cGMP Guide withthe EU GMP Guideline, taking the first document as a starting point. Here,each paragraph with all its subsections (usually a), b), c) etc.) isconsidered in order to maximise the informational value.
2 GMP/ISO 9001 Matrix
When publishing the Guidance for Industry "Quality System Approachto Pharmaceutical cGMP" on 29 September 2004, theFDA took requirements from the ISO 9001 document on "QualityManagement Systems" into account in the field of pharmaceuticalmanufacture. The Guide does reference ISO 9001 and include arecommendation; however, the outline does only focus on a partial comparisonbetween the cGMP Guide and ISO 9001. The ISO standard contains additionalinformation on building up quality management systems. In our GMP/ISO 9001Matrix, each paragraph of the cGMP Guide is linked to the correspondingpassage in ISO 9001.
Both Matrices are linked with each other in one document. The followingscreenshot shows you the structure:
Theabove-mentioned Matrix is part of the ECA Good Practice Guide: "FDAcGMP, EU GMP and ISO 9001 Matrix for a pharmaceutical Quality System - AGMP Roadmap". The Good Practice Guide includes the Matrix as well asthe complete texts of the FDA cGMP Guide (21 CFR 210/211), the PIC/S GMPGuide (identical with the EU GMP Guide) and ISO 9001.
The ECA invites all interested circles from industry and authorities tocontribute to the development of this document. Please send your commentsand suggestions for improvements or potential extensions to the ECASecretariat (info (at) gmp-compliance (dot) org).
This Matrix has 20 pages as well as further 390 pages for thethree regulations. The regulations have been licensed by the respectiveorganisations. 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.
The European Compliance Academy is organising the GMP Education Course
FDA's New Quality Systems and RiskApproach 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).