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@gmp-compliance.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.
|
