How can one find a certain GMP requirement in the EU GMP Guide, in the FDA cGMP Guide and in the ISO 9001 without searching for a long time? The Good Practice Guide developed by the ECA has become a standard in many companies and is aimed at providing this information. A 26 pages matrix provides information about where to find a GMP requirement e.g. on Validation, QC Lab testing etc in the three major Guidelines. The comprehensive booklet with 500 pages contains a full text version of all three guidelines. You can find the GMP Matrix here.
http://www.gmp-compliance.org/eca_handbuecher.html
Publications
ECA Good Practice Guide – “GMP Matrix”
“FDA cGMP, EU GMP and ISO 9001 Matrix for a pharmaceutical Quality System – A GMP Roadmap”. (Version 15 of April 2014)
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 updated Matrix now has 26 pages as well as further 500 pages for the following three regulations
- FDA cGMP Guide
- EU GMP Guide Part I, II, and III incl. all Annexes
- ISO 9001 Quality Management Systems
In addition, the Good Practice Guide contains a ISO 9001/ICH10 Matrix and the complete Part III to the EU GMP Guide.
Price*: € 149 Non ECA Members, € 99 ECA Members
Filed under: Regulatory Tagged: FDA cGMP, GMP, GMP Guide, GMP Matrix, Good Practice Guide, ISO 9001
