FDA/EU-GMP-Matrix completely revised

Especially globally operating pharma companies frequently face the question what differences there are between the US cGMP regulations (21 CFR 211) and the EU GMP Guide for Medicinal Products - and what parallels there are? And with regard to medical devices - e.g. Combination Products - there is an additional question: How does the ISO 9001 still fit in these pharma specific regulations?

To support you in answering these questions, the ECA Academy has developed a Good Practice Guide (its "GMPMatrix") years ago. With reference to 21 CFR 211 this Matrix compares the EU GMP Guide, Part I (Chapters 1-9) and the ISO 9001:2008. This comparison is further extended by an additional matrix comparing the ICH Guide Q10 with the ISO 9001. For better readability of the tables the text is reduced to a minimum, and the comparisons concentrate on single paragraphs resp. chapters and sub-chapters with their particular items. To possibly be able to compare word by word all relevant regulations are included in the brochure.

This makes the brochure a real handbook which is frequently used as a quality assurance tool in audits, especially in globally operating companies (see also the GMP News from 10 October 2012 "GMP Matrix as Standard for Audits in many Companies"). It can also be used for a "GAP analysis" when moving between the "GMP worlds" USA and Europe. And it further shows where the GMP regulations are more specific in comparison with ISO 9001.

Due to the changes in Chapters 3 and 5 (please see also GMP News from 12 February 2015 "EU issues new Version of GMP Guide Chapters 3 and 5") as well as in Chapter 8 (please see GMP News from 23 September 2014 "Complaints and Recalls: new EU-GMP Chapter 8 published") the Matrix also had to be adapted. Just on time with the validity date 1 March 2015 of the revised chapters the Matrix is up-to-date again and available in version 17. It can be purchased via the ECA Academy website - charges for ECA members are 99,- EUR, for non-members 149,- EUR.

PLEASE NOTE: As a delegate of the 6th European GMP Conference, scheduled in Heidelberg, Germany, from 9-10 June, you will receive the GMP Matrix as a free of charge add-on. As organiser of this biennial Conference it is the ECA's goal to contribute to the harmonisation of GMP. And the GMP Matrix is a major contribution in these harmonisation efforts.

The comprehensive revision makes the GMP Matrix a compact compendium comparing the two "GMP worlds" USA and Europe, and is thus a very helpful QA tool for auditors. The additional comparison with the ISO 9001:2008 further provides indications where the GMP regulations are more specific, making it helpful for manufacturers of Combination Products or suppliers.

 

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