GMP Matrix – EU GMP Guide – FDA cGMP Guide and ISO 9001 comparison

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New Drug Approvals

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…

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