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GLP Analytics

Welcome to the "GLP Analytics" Working Group:

The working group "analytics" has currently 64 participants of research and development mainly pharmaceutical, agricultural and chemical industry as well as contract research organization.
The working group is concerned with all questions on analytics which can occur within the range of the GxP-regulated test facilities / test sites.
A goal of the working group is a regular exchange of information and experience with mainly concerned Good Laboratory Practice. The working group meets at least once a year in order to work on current topics by presentations and discussions. The results of the working group meetings will be published on the DGGF member only area and in the DGGF NEWS.

The last meeting for discussing questions on analytics conducted in a GXP regulated test facility / test site took place on June Friday 06, 2014 at Allessa in Frankfurt am Main - Fechenheim, Germany. The result was published on the member only area and in the DGGF NEWS.

The next meeting is sheduled on Wednesday May 20, 2015 at Merck Serono, Merck KGaA DMPK, in Grafing (near München).
The following topics are sheduled:
Certificate of Analysis – GLP, GMP and further requirements in pharmaceutical, agricultural and chemical industry.
Method Validation (bioanalysis, analysis (e.g. field studies) , formulationanalysis – in pharmaceutical, agricultural and chemical industry) – GLP, GMP, GCP and further requirements.
Raw Data – How deep is the documentation – „less is more" - e-Data / Paper
Analytical Reports (bioanalysis, analysis (e.g. field studies) , formulationanalysis – in pharmaceutical, agricultural and chemical industry) - GxP, GRP* and further requirements.

*Good Research Practice

In 2014 the DGGF International Annual Meeting tooke place from September 18 to 19 in Magdeburg, Hotel Maritim. Presentations concerning analytics were integrated in a "Analytics / IT" session.
The topics of the program were as follows:
• Validation of methods for biomarker analysis in clinical trials: regulatory re-quirements and challenges, Stephan Wnendt.
• Documentation on sample preparation for analysis – how deep is necessary and how deep is meaningful, Timo Kretzschmar
• Strategies for long-term retention of laboratory data, Burkhard Schäfer
• A risk-based approach to IT-Vendor Management at Bayer Health Care, Olga Stoll.
• Issues of file-based acquisition system using windows operating systems and its impact on validation, Ronald Schmidt.

Members of the DGGF has now the possibility to discuss questions in the "Forum" at the member only area of the DGGF website.

If you have questions about the work of this working group, please contact the working goup leader:

Andreas Henrichs
Tel.: +49 (0)69 305 24141
Sanofi-Aventis Deutschland GmbH



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