Responsibilities of the Test Facility Management

These various situations are graphically represented in figure 9. It lies in the responsibility of the test facility management to investigate the possible interrelations between the various test facility units and their common involvement in studies to select the most appropriate individuals for performing the respective Quality Assurance functions. 

In order to attain its purpose, any quality system needs to define very clearly the different levels of responsibility. The definition of the test facility management serves to delineate these responsibility borderlines, and it invests test facility management with the ultimate power for ensuring GLP compliance. 

There are major facilities and closely related facilities required to perform a GLP study. In fact, a test facility should be of suitable size, construction, and location to meet these requirements. These characteristics are to minimize disturbances that would interfere with the study validity. The design of the test facility should provide an adequate degree of separation for activities, to ensure the proper conduct of each study. Further, management is responsible for providing personnel, laboratory, materials, equipment, test system, and other facilities for the GLP study. In brief, these may be grouped as (1) personnel (2) laboratory (3) test system (4) archive and (5) disposal. The details of the facilities may be seen in the International Organizations heading of this chapter. 

All this amounts to the requirement that it is the test facility management, who is ultimately responsible for ensuring full compliance with the GLP Principles throughout the facility as a whole. In order to deliver its responsibility, it will need some mechanism of continuous control. Therefore, an essential management responsibility is the appointment and effective organisation of an adequate number of appropriately qualified and experienced staff throughout the facility, including those specifically required to perform QA functions. 

However, the responsibility of management does not end with the appointment of the Study Director it has also to make allowance for the possibility that, once appointed, a Study Director could become temporarily or permanently unavailable for the continuous or continuing supervision of the study. In such cases, the replacement of the Study Director, whether temporary or permanent, will have to be considered by the test facility management, taking into account the prospective duration of absence. If the absence of a Study Director could be foreseen to last for a longer period of time (up to a permanent absence), the need for a permanent replacement would certainly... 

The very same responsibilities are applicable for the case, where the management has to appoint, in addition to the Study Director, also one (or more) Principal Investigator(s). Of course, here is a distinction to be made The management which appoints the Study Director can only appoint Principal Investigators in its own test facilities or test sites. When study parts are out-sourced to an independent GRO, the management of this GRO consequently becomes responsible for the nomination of the respective people. The management of the test facility, where the Study Director is located, is then, however, responsible for ascertaining that there are clear lines of communication between the Study Director and the Principal Invest -... 

Besides these scientific aspects of the Study Director s responsibilities, there are a number of more managerial responsibilities, which are, however, as important for the proper conduct of a study as are the scientific principles involved. Already before any work on the study is undertaken, the Study Director should ascertain that management have committed adequate resources to perform the study, and that adequate test materials and test systems are available. In other words, a Study Director should never take on the assignment for the conduct of a study, for which there are no adequate resources. It would therefore certainly lie in the Study Director s responsibility to alert the test facility management about any such deficiencies and to insist on their remediation, as it would, vice versa, become the responsibility of test facility management to react to such an alert with proper measures. 

First of all, the sponsor should be knowledgeable in the requirements of the GLP Principles. Since the connections between sponsor and study will be mainly through the test facility management and the Study Director, and/or the Principal Investigator, the sponsor should be aware of their responsibilities towards the study, and especially of the fact that the full responsibility for the whole study remains with the Study Director, including the validity of the raw data and the report, notwithstanding any elements of the study which may or may not have been disclosed to the Study Director, as they have been obtained at the sponsor s own test facilities. 

In the most simple case, where the Quality Assurance is located at the same place as the Study Director and the test facility management, there should be no problem with reporting and the subsequent responses from the two addressees. There are, however, more complex situations where the Quality Assurance has no direct connections with the Study Director and his or her management. One might consider for instance the situation in a field study, where parts of the study are performed at test sites remote from the Study Director s test facility. Even if these test sites were to belong to the same... 

It certainly goes without saying that other general responsibilities, of management, of Study Directors, of personnel and of Quality Assurance, will also have to be applied with regard to computerised systems. Thus, personnel should be appropriately trained in the operation and maintenance of computerised systems, adequate facilities for the location of such systems (especially for the central, core hardware of the test facility s computer network) have to be provided by management in the same way as for the localisation of other equipment, and Quality Assurance has to ascertain routinely the GLP compliance in the utilisation of computerised systems. 

Test facility management means the person(s) who has the authority and formal responsibility for the organization and functioning of the test facility according to these Principles of Good Laboratory Practice. 

With the definition of the management the GLP Principles are setting the stage for a successful functioning of a test facility. It stands to reason that there has to be some position of ultimate responsibility for any question or problem that might arise out of the sometimes divergent interests and opinions of the two instances responsible for the GLP-compliant conduct of studies, namely the Study Director and the Quality Assurance. 

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