Accreditation and Quality Assurance

, Volume 13, Issue 9, pp 511–521

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

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

Abstract

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.

Keywords

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

Abbreviations

DQP

Department quality policy

FDA

Food and Drug Administration

GLP

Good laboratory practice

HPLC

High performance liquid chromatography

LIMS

Laboratory information and management system

MSR-QMS

Merck Serono Research-quality management system

OECD

Organization for Economic Cooperation and Development

PCR

Polymerase chain reaction

QA

Quality assurance

QD

Quality delegate

QAU

Quality assurance unit

QM

Quality management

SOP

Standard operation procedure

WHO

World Health Organization

Copyright information

© Springer-Verlag 2008

Authors and Affiliations

  • Barbara Pohl
    • 1
  • 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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