Differences in the interpretation of the GLP requirements by OECD monitoring authorities: the point of view from the pharmaceutical industry.
The need to harmonise the principles of good laboratory practice (GLP), their application and their monitoring has always been a preoccupation of the authorities. This can be seen by the very early publication of the set of Organisation for Economic Co-operation and Development (OECD) documents, the training of the national inspectors, and the system of joint mutual visits. These aspects are now, for the most part, aligned. However, often the expectations of the inspectors and the interpretation behind the text are different and sometimes even opposite. In Sanofi-Aventis there is an almost unique position having 12 research and development sites in 7 different countries, all performing phases of studies which can be used by any of the other sites and all inspected by monitoring authorities (MAs) of the OECD GLP system. As with most international pharmaceutical companies a large majority of studies are multisite and even multicountry. This paper illustrates some of the challenges which are encountered when a global system of high quality is established to satisfy all the expectations of the multiple MAs, with particular reference to the diversity of origins of the requirements, specific guidance documents on GLP, question and answer sessions on GLP interpretations, annex requirements on specific areas (21 CFR Part 11, veterinary legislation etc.) and conference presentations by MAs. It is important to realize that even though there might be interpretations that the industry has some difficulty in understanding, the objective of this paper is not to complain or to criticize one or other of the MAs. Rather, the objective is to try to be constructive and to show where there are differences so that industry and the MAs can work together to establish systems which possess the level of quality necessary to ensure the safety of patients and the marketing of efficient products.
Lowing
Raymond K
RK
GLP Quality & Compliance, Sanofi-Aventis Research & Development, 1 Avenue Pierre Brossolette 91385 Chilly-Mazarin, France. raymond.lowing@sanofi-aventis.com
D019411:Clinical Laboratory Techniques / Q000592:standards*; D004345:Drug Industry / Q000592:standards*; D004467:Economics; D007390:International Agencies; D012926:Social Control, Formal