Accreditation and Quality Assurance

, Volume 13, Issue 9, pp 511–521 | Cite as

Current experiences with a quality management system for non-clinical research and development in pharmaceutical industry

  • Barbara PohlEmail author
  • Stephanie Simon
  • Peter-Jürgen Kramer
Practitioner's Report


Quality management is one of the most important issues in pharmaceutical research as it determines the validity and reliability of data, data and data evaluation being the central products of all research activities. In this business it is of outstanding importance to generate valid data for the assessment of drug development candidates to assure that the huge financial investment, which is based on such assessments, can be successful. Efficacy and safety of products are the final goals of such developments. Therefore, Merck/Merck Serono implemented an additional specifically developed quality management system that covers all areas and locations in Merck Serono Research that were not yet regulated by an existing regulatory quality management system, e.g. GLP (Good Laboratory Practice). The system is known under the name Merck Serono Research-Quality Management System (MSR-QMS). Thus, we describe the implementation process of MSR-QMS as a research specific quality management system in a global company. Furthermore, the implementation process in one specific research department will be highlighted. Using a practical example, the validation of an analytical instrument in a MSR-QMS-regulated research laboratory will be shown and compared to a validation process in a strictly GLP-regulated area. A summary of the experiences with the new quality system will complete this article and the advantages of high quality research results in industry will be discussed.


MSR-QMS (Merck Serono Research-quality management system) Optimizing of processes in research Validation IT lifecycle 



Department quality policy


Food and Drug Administration


Good laboratory practice


High performance liquid chromatography


Laboratory information and management system


Merck Serono Research-quality management system


Organization for Economic Cooperation and Development


Polymerase chain reaction


Quality assurance


Quality delegate


Quality assurance unit


Quality management


Standard operation procedure


World Health Organization



The authors wish to thank Alain Muller, Merck Santé, Lyon, for his support in the MSR-QMS implementation at Merck’s Institute of Toxicology.


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Copyright information

© Springer-Verlag 2008

Authors and Affiliations

  • Barbara Pohl
    • 1
    Email author
  • Stephanie Simon
    • 1
  • Peter-Jürgen Kramer
    • 2
  1. 1.Merck KGaA, Merck Serono Research/TOX-GLP, Non Clinical Development, Institute of ToxicologyDarmstadtGermany
  2. 2.Merck KGaA, Merck Serono Research/Quality AssuranceDarmstadtGermany

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