How does Good Laboratory practice improve quality?

Abstract: Abstract Bachelor’s degree thesis in Business Administration School of Economics and Management, University of Växjö, FEN 330, Spring 2006 Authors: Malin Jansson and Mirja Wynn-Williams Supervisor: Stig Malm How does Good Laboratory Practice improve quality? Background: The quality systems that steer manufacturing of pharmaceutical products from the testing phase to commercial manufacturing are the national and international regulatory frameworks and legislation. Good Laboratory Practice (GLP) is a quality system concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported. In Sweden the Medical Products Agency monitors and regulates compliance with the principles of Good Laboratory Practice. Aim: The aim of our thesis is to explore the reasons why companies/laboratories adopt Good Laboratory Practice. We shall do this by identifying the advantages and disadvantages of adopting GLP principles for companies/laboratories, and how quality is improved by adopting GLP principles. We have summarized our aim in one principal question: How does Good Laboratory Practice function as a tool for quality improvement? Limitations: We will focus on GLP, and this thesis will not consider other Good Practice procedures such as Good Manufacturing Practice or Good Clinical Practice. Only laboratories in Sweden monitored by the Medical Products Agency are targeted in the empirical part of this work. Method: Literature research and interviews with GLP contact persons listed by MPA. Results and conclusions: Though costumers’ needs and legislation seem to be the motivations for companies deciding to comply with GLP, quality improvement seems to be the biggest advantage of validation. Proposal for further research: Do laboratory assistants and technical employees differ from management in their experience and views on GLP?