EDQM Issues Q&A Documents on Harmonised Microbiological Test Procedures

GMP News
5 September 2007

EDQM Issues Q&A Documents on Harmonised Microbiological Test Procedures

One of the currently most discussed topics in the pharmaceutical industry is the implementation of the harmonised microbiological test methods.
Recently, we informed you about some very helpful statements given by the Quality working Party of EMEA on that topic (see GMP news from 1 August 2007). Now the European Directorate for the Quality of Medicines (EDQM) has published some interesting documents on its website.
In two Power Point presentations members of the EP Expert Group 1 "Microbiology" give answers to questions which they received from the pharmaceutical industry. Professor Hans van Doorne from the University of Groningen discusses the chapter 2.6.12 in his slides whereas Sylvie Guyomard Devanlay - representing France in the Expert Group 1 - gives some input on the chapter 2.6.13.
Fortunately, both authors provide responses to very down-to-earth questions. Therefore, these slides are of benefit to everyone engaged in the implementation of the new harmonised test methods.
You will find the documents at

The impact of the harmonised test procedures is one of the key issues that will be discussed at ECA's Education Course "Microbiological Best Laboratory Practice" from 13-15 February 2008 in Prague, Czech Republic.

Dr. Ulrich Herber
On behalf of the European Compliance Academy (ECA)
PS: Don't forget to register for ECA's Working Group on Rapid Microbiological Methods at www.gmp-compliance.org.

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