OECD consensus

In view of the high frequency and routine nature of some short-term studies, it has been recognized in the OECD Consensus Document on QA and GLP that each study need not be inspected individually by the QA during the experimental phase of the study. In such cases, a process-based inspection may cover each study-type. 

A more recent OECD consensus paper [5] requires the development of software in a quality system environment There should be adequate documentation that each system was developed in a controlled manner and preferably to recognized quality and technical standards (e.g. ISO 9001) Similarly the European Union requires in Annex 11 of the EC guide to good manufacturing practice (GMP) for medicinal products [6] The user shall ensure that software has been produced in accordance with a system of quality assurance . 

The use of computerized systems by test facilities for the generation, measurement, or assessment of data is nowadays consolidated and computerized systems are fully integrated into the in vitro method. It is essential that for regulatory applications computerized systems are developed, validated, operated, and maintained in accordance with the OECD Consensus document No. 10 on The application of the principles of GLP to computerised systems [13] and specific guidance documents [14, 15]. 

It can be stated without any exaggeration that the most important individual in the context of GLP compliance is the Study Director. The Study Director, who is defined - in rather innocent looking wording - as the individual responsible for the overall conduct ofthe non-clinical health and environmental safety study , is the one person who is the central and pivotal individual within, and for, the whole study. The OECD Consensus Document on the Role and Responsibility of the Study Director (OECD No. 8, 1999) elaborates on this definition, and it very clearly describes the role of this individual as the sole point of study control . It is the Study Director who is the only person who bears the ultimate responsibility for adherence to the GLP Principles. In aU offices and laboratories around the world from time to time the old joke is displayed on the blackboard about the four people, named Somebody, Nobody, Anybody, and Everybody ( Somebody should do it. Everybody thought that Anybody could do it, and Nobody did it ). The GLP Principles want to avoid such a situation, which would jeopardise the recon-... 

It has to be observed at this point, that, in a very unobtrusive way, with this definition of the Principal Investigator a term has been smuggled into the GLP Principles which could give rise to difficulties in the interpretation of other requirements. This term, the phase of a study, has not been defined in the Principles, and thus had become very much open to the need for interpretation. Although the term has subsequently been defined in the OECD Consensus Document on Multi-Site Studies (OECD No. 13, 2002), it will be specifically dealt with in section 2.10 (see page 97). 

The term phase(s) of a study is used at various places in the OECD Principles however, this term was not defined in the Principles and its use has given rise to questions about its meaning, its applicability, and indeed its value in the context of GLP. Even though a definition for this phrase is lacking in the Principles themselves, the term has to be dealt with in this section on definitions, since a clarification of its meaning should be of some importance for the discussion of various other issues in the application of GLP, and since there is now a definition in the OECD Consensus Document on Multi-Site Studies (OECD No. 13, 2002). 

There are many more questions involved in these instances of splitting studies into various, practically independent parts. The question of, e.g., the various problems of Quality Assurance involvement with regard to the Quality Assurance statement in such fragmented studies will be investigated in more detail in section 4.5 (see page 163). The existence of such a great number of more or less unresolved issues within the conduct of multi-site studies finally led to their broad discussion and resolution in an OECD Consensus Document (OECD, 2002). A further problem, which cannot be resolved in the context of GLP, is the question of confidentiality and of various shades of competitor relationships. These issues have to be dealt with in the context of the contractual provisions and need not be considered further in the context of this book. 

Already the Consensus Document on Quality Assurance (OECD No. 4, 1999) had recognised that these two possibilities would not sufficiently describe the real-life inspection activities of a Quality Assurance unit, and the revised GLP Principles have acknowledged this extended view of inspection types. Inspections dealing with the conduct of, and the activities within, a study are now further subdivided into two different types, so that there are finally three types of inspections, which are just named in the OECD Principles, are described in the OECD Consensus Document on Short-Term Studies (OECD No. 7,1999), and which have to be further specified by Quality Assurance Programme Standard Operating Procedures. These three types are ... 

In the second case, the question of whether the sponsor performing the analyses would indeed be in a position to generate these data under the provisions of the GLP Principles, the sponsor obviously has to be made aware of this requirement by the Study Director. The GLP Principles do burden the Study Director with the responsibility of ascertaining the GLP compliant conduct of the whole study. This responsibility implicitly includes - as has been explicitly stated in the respective OECD Consensus Document (OECD No. 8,1999) - that the Study Director should be aware of the GLP compliance status of any facilities or sites involved in the study. If a contract facility were not GLP compliant, the Study Director would have to indicate this in the final report. Therefore, in the event of an unsatisfactory answer from the part of the sponsor, the Study Director would have to exclude the performance of this analysis from the GLP statement, and it is then again up to the Receiving Authority to judge whether these data can be considered acceptable or not. 

OECD, Consensus Documents for the Work on the Safety of Novel Foods and Feeds, Organization for Economic Cooperation and Development, Paris, 2006. http //www.oecd.Org/document/9/ 0,2340,en 2649 34385 1812041 l l l l.OO.html... 

OECD (2010), Safety Assessment of Transgenic Organisms OECD Consensus Documents Volume 3, OECD Publishing. 

SAFETY ASSESSMENT OFTRANSGENIC ORGANISMS OECD CONSENSUS DOCUMENTS VOLUME 3 OECD 2010... 

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