29/30 March 2023
One often wonders which differences do exist between the US American cGMP regulations (21 CFR 211) and the EU GMP Guide - and which parallels they have. What's the place for ISO 9001 in these specific phama regulations? In order to help finding an answer to these questions, the ECA developed a Good Practice Guide "GMP Matrix" a few years ago. The guide - which takes 21 CFR 211 as a reference - presents comparisons to the EU GMP Guide Part I (Chapters 1-9) and to ISO 9001: 2008 (including Corrigendum). In addition, it provides a juxtaposition of the ICH Guideline Q 10 and ISO 9001. To keep both tables as readable as possible, text sections have been reduced to the minimum and the comparisons are reduced to the respective paragraphs and chapters/subchapters focussing on the key elements. For a word by word comparison, the relevant regulations have been included in the brochure.
Thus, the brochure serves as a guide which is used as quality assurance tool for audits by many companies - especially international ones (see our GMP News from 10 October 2012). It also may be used for "GAP analysis" by those involved in US American and European GMP environments. Moreover, the brochure presents the elements which are more detailed in the GMP regulations than in ISO 9001.
Because of the changes with regard to chapters 1 and 7 of the EU GMP Guide (effective since 31 January 2013, see our GMP News from 12 September 2012 on the Changes in Chapter 1 and the Changes in Chapter 7 as well our GMP News from 30 January 2013), the GMP Matrix has now been revised. Thus, the 12th edition is now "up to date". The GMP Matrix is available via the ECA wwebsite. ECA Members can buy the GMP Matrix for 99,- Euro. Non-Members have to pay 149,- Euro.
Delegates of the 5th European GMP Conference on 6/7 June 2013 in Heidelberg will get the GMP Matrix as a free add-on. This year, the event will celebrate 50 years of GMP and will deal with the topic "Harmonisation of GMP". The GMP Matrix plays an important role for this harmonisation purpose.