DPhG - Pharmaceutical Analytics

DPhG - Pharmaceutical Analytics

Working Group Drug Qality Control/ Pharmaceutical Analytics of the German Pharmaceutical Society (DPhG)

Consensus paper: Establishing Specification Acceptance Limits

Consensus paper of the Working Group Drug Quality Control / Pharmaceutical Analytics of the German Pharmaceutical Society (DPhG), in collaboration with the Arbeitsgemeinschaft für Pharmazeutische Verfahrenstechnik (APV; engl: International Association for Pharmaceutical Technology) Efficient and economical HPLC Performance Qualification

Positionspapier der Deutschen Pharmazeutischen Gesellschaft zum Thema Spezifikationssetzung (verabschiedete Fassung)

Establishing Spezification Acceptance Limits

Positionspapier der Deutschen Pharmazeutischen Gesellschaft zum Thema Spezifikationssetzung (Entwurf)

Board

Chairman

Prof. Dr. Hermann Wätzig

My scientific interests are within pharmaceutical and biomedical analyses, emphasising separation techniques such as capillary electrophoresis, HPLC and mass spectrometry, protein and proteom analysis, quality assurance of biotechnological produced drugs and statistical quality control.

Prof. Dr. Hermann Wätzig
Institute of Pharmaceutical Chemistry
Beethovenstr. 55
D-38106 Braunschweig
Germany

h.waetzig(at)tu-bs.de
Phone: +49 (0) 531 - 391 2764 oder 391 2751
Fax: +49 (0) 531 - 391 2799

2nd Chairman

Dr. Klaus Raith

Landesamt für Verbraucherschutz Sachsen-Anhalt
Dezernat 24 - Arzneimittelprüfstelle
Wallonerberg 2-3
39104 Magdeburg

klaus.raith(at)lav.ms.sachsen-anhalt.de
Phone. +49-391-5377230
Fax +49-391-5377235

Secretary

Pharmacist Mona Mozafari

Pharmacist Mona Mozafari is Ph.D. student in the research group of Prof. Dr. Hermann Wätzig. Her scientific domains are Capillary Electrophoresis (CE) with an emphasis on Affinity CE (ACE).

Pharmacist Mona Mozafari
Institut für Pharmazeutische Chemie
Beethovenstr. 55
D-38106 Braunschweig
Germany

m.mozafari-torshizi(at)tu-braunschweig.de
Phone: 0531 - 391-8453
Fax. 0531 - 391 2799

The section of Drug Quality Control/Pharmaceutical Analytics of the German Pharmaceutical Society (DPhG) exists since 1991. It emanates from the section of the Drug Quality Control of the DDR. It consists of a scientific forum for all pharmacists and scientists who work in teaching, research and development and scientists of other areas who are also involved in the quality assurance of drugs. The section represents the interests of all who are employed at the university, industry and agencies or other facilities of quality assurance of drugs or pharmaceutical analytics which are accountable for the chemical research of active ingredients or preclinical and clinical trials.

Objectives

The objectives of the section Drug Quality Control/Pharmaceutical Analytics are:

  • Development, propagation and practice of scientific knowledge and methods
    - for quality assurance of active agents and excipients as well as drugs concerning to their chemical,
    physical and biological attributes and their specification during production and storage
    - for evaluation and prevention of quality-caused risks and
    - for analysis of agents and their metabolites in biological materials
  • Opinion making in principle topics to assess the pharmaceutical drug safety
  • Comments on current topics of pharmaceutical drug safety
  • Assistance to the institutions of quality safety of drugs in the industry, pharmacies including hospital pharmacies, agencies and service laboratories to etablish general standards of quality and safety
  • Delivery of research assignments and interdisciplinary cooperations as well as international, in particular European, cooperation at the specialist area
  • Assistance to universitical and other institutions of specific section of further eduction as well as national and regional committees of the German Pharmaceutical Society (DPhG) to arrange their scientific events

Scientific events are arranged for realisation of the mentioned objectives, including a main symposium which takes place annually with comprehensive symposia, seminars or workshops of special themes.
We are arranging events to the following themes:

  • Qualitiy assurance of biotechnological made drugs
  • Peptide analysis
  • Protein analysis
  • Sample preparation
  • Mass Spectrometry
  • Analytical validation
  • Quality assurance of phytogenic drugs
  • Regulatory affairs
  • Pharmacopoeia analysis
  • Analytical topics about Clinical Pharmacy (Co-symposium with the Working Group Clinical Pharmacy)
  • Pharmacokinetics
  • Separation techniques: chromatography and electrophoresis
  • Sterility-indicating assays
  • Packaging

Are you interested in one of these topics? We shall be glad to inform you about details! Please contact us if you want us to pick up a current theme in the near future!

Membership

With your membership of the section Drug Quality Control / Pharmaceutical analytics you support our business to afford a discussion forum out of current questions of drug control and to comment. If you are member you will get circular letters with current informations about events of the section and of all important themes of the drug control area which the section concerns with (Consensus papers, comments …). Members of the German Pharmaceutical Society (DPhG) get their membership in the section by declaration without extra payment of contributions. Please send your declaration to:

info(at)dphg.de
cc: h.waetzig(at)tu-bs.de

or postal to:

Deutsche Pharmazeutischen Gesellschaft
Geschäftsstelle
Dr. Michael Stein
Varrentrapstr. 40-42
60486 Frankfurt
Phone 069/7191-596-0
Fax 069/7191-596-29

If you are no member of the German Pharmaceutical Society (DPhG) yet: You will find an online registration form and a pdf-file for registration on the homepage of the society.

http://www.dphg.de

With your access in the membership of the DPhG you can explain your access in our section at the same time.
If you have any questions regarding your membership, do not hesitate to contact me:

Prof. Dr. Hermann Wätzig
h.waetzig@tu-bs.de
Phone: +49 (0) 531 - 391 27 64

Contact

If you want to get further informations about ongoing events we will accept your email address in our mailing list. Please contact d.eberle(at)tu-bs.de

Section meetings

Section meeting 2016

Braunschweig, 09.-10.03.2016

Main focus: Micro- and nanotechnologies

Abstracts (presentation, poster)

Presentations: Heike Bunjes, Thomas P. Burg, Andreas Dietzel, Georg Garnweitner, Judith Kuntsche, Arno Kwade, Staffan Nilsson, Stephan Reichl, Ingo Rustenbeck, Thomas Scheper, Philip Tinnefeld

Section meeting 2015

Braunschweig, 11.-12.03.2015

Main focus: Tailor-made proteins

Program

Presentations: Müller-Goymann, C. (Das Zentrum für Pharma-Verfahrenstechnik; Proteinbeladene Hydrogele in der Wundheilung); Hust, M.; Scherübl, C., Haefele, F.; Bunjes, H.; Baydoun, L.; Veurink, M.; Hunzinger, C.; Räthel, T., Sadowski, G.

Section meeting 2013

Freiburg, 08.-09.10.2013

Main focus: Facets of drug safety

Program

Presentations: Dingermann, T., Funke, A., Girard, P., Hoferichter, R., Keitel, S., Kohl-Himmelseher, M., Renger, B., Schweim, H., Tawab, M., Watt, S., Wätzig, H.

Section meeting 2012
Greifswald, 10.10.2012

Main focus: Special instrumental techniques for pharmaceutical analytics

Program

Presentations: Arvidson, T., Blazewicz, A., Heinz, A., Holzgrabe, U., Lämmerhofer, M., Langfermann, C., Link, A., Wätzig, H.

Section meeting 2011
Innsbruck, 20.-21.09.2011

Main focus: Analytical insights into the molecular level

Program, abstracts

Presentations: Bogan, R., Cianciulli, C., Glauser, D., Girard, P., Grotefend, S., Mechtler, K., Mayrhofer, A., Ott, I., Raith, K., Schmelzer, Chr., Watt, S.

conference proceedings

Section meeting 2010
Braunschweig, 06.-07.10.2010

Main focus: Pharmaceutical analytics at universities, physical and pharmaceutical-technological methods

Program, abstract

Presentations: Heilmann, J., Holzgrabe, U., Jose, J., Jung, M., Langguth, P., Lehmann, T., Wundrack, A., Petrich, M., Raith, K., Scriba, G., Sproß, J., Vielle, C.

Section meeting 2009
Jena, 28.-29.09.09

Main focus: Quality Control: Speed matters

Program, abstract

Presentations: W.-D. Beinert, D. Belder, K. Buckendahl, A. Clarke, L. Kaminski, B. Kammerer, S. Kromidas, F. Michel, H. G. Schweim, W. Vautz, T. Zimmermann.

Section meeting 2008
Bonn, 10.-11.10.08

Main focus: Biologicals - requirements of quality and analysis

Program, abstract

Presentations: M. Blüme, T. Dingermann, J.Jose, J. Leube, B. Renger, S. Schröder

Section meeting 2007
Erlangen, 12.-13.10.07

Main focus: Drug control and regulatory requirements

Abstract

Presentations: R. Bogan, R. M. Bonner, J. Ermer, K. Eggert-Bury, A. Grummel, J. Limberg, K. Raith, B. Renger, M. Tegtmeier, H. Wätzig.

Section meeting 2006
Marburg, 4.-5.10.06

Main focus: Quality and analysis of herbal drugs

Program, abstract

Presentations: G. Franz, F. Gaedcke, Höwer-Fritzen, L. Kabelitz, K. Keller, M. Keusgen, W. Knöss, H. Sievers, M. Tegtmeier, M. Wurglics

Section meeting 2005
Mainz, 5.-6.10.05

Main focus: Analytical uncertainty

Program, abstract

Presentations: J. Ermer, K. Heydorn, L. Jänsch,  F. Malz, J. Ohnesorge, H.-J. Ploss, K. Schad, U. Schepers, L. Weinandy

Section meeting 2004
Regensburg, 6.-7.10.04

Main focus: Analysis of complex matrices

Program, abstract

Presentations: G. Blaschke, M. Hamdan, R. Mader, A. Meichle, D. Oechtering, K. Pittertschatscher, K. Raith, L. Schönberg, H. Spahn-Langguth, R. Trittler, M. Unger

Section meeting 2003
Würzburg, 8.-9.10.03

Main focus (first day): Package: a challenge for modern instrumental analysis

Program, abstracts

Presentations: H. Hamacher, H.-W. Motzkus, T. Mundry, J. Pfeifer, E. Rädlein, K. Raith, H. Wätzig, J. Zürcher

Section meeting 2002
Berlin, 8.-9.10.02

Main focus: Analytical validation: from complexity to admission

Program

If you want to get further information about actual events we will accept your email address in our mailing list.
Please contact d.eberle(at)tu-bs.de.

Continuative links