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