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GLP Analytics

Welcome to the "GLP Analytics" Working Group:

The working group "analytics" has currently 66 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 Wednesday May 20, 2015 at Merck Serono, Merck KGaA DMPK, in Grafing (near München)
As an example the topics as follows were discussed:
  • 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

Within the DGGF International Meeting from 24. to 25. September 2015 at Maritim Hotel in Ulm (Germany) prasentations concerning analytics took place in "Stream GLP_4" (GLP Session) and "Stream GxP_3" (Plenary Session) as follows:
  • Friday 25. September 2015, 11:00 am to 11:45 am, Stream GLP_4 - "How to get the bussines started - Selection of CROs in China (outsourcing of bioanalytical work)", Margarete Brudny-Klöppel, Bayer Pharma AG
  • Friday 25. September 2015, 11:45 am to 12:30 pm, Stream GLP_4 - "Keeping Conformity and Compliance to Analytical Part of GLP / GCP in Borderline Cases – QA Experience in a Bioanalytical CRO", Timo Kretzschmar, pharm-analyt Labor GmbH
  • Friday 25. September 2015, 14:00 pm to 14:45 pm, Stream GxP_3 - "EU Regulator`s Viewpoint as why Regulatory Guidelines should NOT be followed", David R Jones, MHRA, UK

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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