Testing facility, definition

The first section in each set is titled "General Provisions." In this section, in separate numbered paragraphs, the scope of the regulations is laid out (see Boxes 7.2 and 7.3), a number of definitions are listed, and the applicability of the regulations to studies performed under grants and contracts is covered. Also presented is a paragraph that indicates that the inspection of a testing facility is permitted. Besides these, the EPA GLP includes a statement of compliance or non-compliance as well as a statement on the effects of non-compliance. 

The definitions are for those words and phrases that the reader encounters in the regulations. Examples include quality assurance unit, raw data, reference substance, sponsor, study, study director, test substance, test system, testing facility. See Box 7.4 for these definitions. 

If a facility conducts nonchnical laboratory studies, it is a testing facility and is subject to inspection by FDA to determine its GLP comphance status. If a facility conducts nonchnical laboratory studies as well as studies that do not meet the definition of nonchnical laboratory study, then only those portions of the facihty that conduct nonchnical laboratory studies are subject to a GLP inspection by FDA. The portions of the facihty that conduct studies other than nonchnical laboratory studies are not subject to inspection by FDA unless FDA has inspectional authority under some other set of regulations. 

This all-encompassing definition of person precludes the exemption of any person or legal entity from the definition of sponsor or testing facility if that person or other legal entity meets the definitions of those two terms. 

Once the basic concept had been agreed to then most of the expansion could be accomplished by changing some definitions. For example, a "laboratory" has become a "test facility" and a "test facility" can be defined as the place where a test is conducted. This immediately moves us out of the traditional laboratory and encompasses field studies, ecotox studies, genetic tox studies, reentry studies, etc. 

We have redefined "test facility", we have redefined "study". The next definition has to do with the living system that is undergoing the test. Up to now this has been traditionally rodents, dogs and primates. By using the term "test system" and defining "test system" as that to which the test substance is applied, we can now include soil, rodents, primates, bacteria and so on. I will not go into the specific proposed changes.in the text but you will see the emphasis in the text below which highlights the titles of certain sections ... 

Fourth, following written standard operating procedures. There is no mystique to SOPs, they are the heart of any test facility. They assure that everyone follows the same procedure each time, that there is no oral law that supercedes the written text. How detailed should these be There are text books on the market with standard operating procedures written in - just like you go to the stationary or office supply shop and buy a standard form will or rental agreement. You have to fill in the blanks. My definition of an SOP is a written procedure that can be followed by any well informed qualified individual with the complete expectation that the anticipated result will be obtained. Can an instruction book be an SOP Probably not. Most instruction books are written as if they had been badly translated from a foreign language. They are frequently difficult to understand. The instruction book can certainly be a part of the SOP, but rarely the SOP itself. 

Details of the GLPs and GLP inspections may be found on government-specific websites. Many are listed in the references below. Briefly, the FDA GLPs, define the scope of the regulation and have a detailed listing of definitions. If the FDA is to consider a nonclinical laboratory study in support of an application for a research or marketing permit, the testing facility, records and specimens must be available for inspection by an authorized employee of the FDA. 

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. 

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. 

Thus, the definition of the test facility, originally a very simple one, had to be expanded in order to include the possibility of utilising one or more test sites as additional places where parts of a study could be performed, and to separate the requirements for such test sites from the ones needed for a test facility. This new distinction between the full test facility and the - in some respect - restricted test site might have (regulatory) consequences for the classification of certain enterprises which are offering the conduct of specialised parts of studies (e.g. histopathology evaluation, analytical or clinical chemistry services). 

In the wake of this introduction of the possibility of conducting studies at more than one location, another new concept had furthermore to be introduced, namely the one of the multi-site study . Thus, the definition of the test facility now does not only cover the single place where the Study Director is located, but for these multi-site studies, those which are conducted at more than one site the term test facility comprises the site at which the... 

Generally speaking, the Principles of GLP require that certain formal procedures be respected on different levels of test facility organisation and study conduct in order for a study to become GLP compliant. A number of these, however, if fully observed, can be considered as out of proportion with regard to their labour and time requirements in comparison to the respective requirements for the actual, experimental conduct of studies of the shortterm type. Thus, the definition of a short-term study becomes important for several aspects of GLP compliance. 

The master schedule, according to its definition, has in the first instance to give information about the workload at the test facility. For it to become a true instrument to gauge the actual workload, the master schedule has to contain information on all studies performed or planned at this test facility, and not on the GLP studies only. It would certainly be advisable to mark or distinguish GLP conforming studies from others, since these will be those most rele-... 

One important aspect of the study plan has already been discussed in section 2.8 (see page 88), namely the fact that even the best conceived plan may be in need of alterations as dictated by study events, and that therefore mechanisms have to be defined by which such changes can be introduced. While the definitions of the terms amendment and deviation have been treated in the above mentioned section, it remains at this point to draw the attention to a small but nevertheless important difference between the ways the study plan and any amendments to it are to be treated with regard to their approval. While the study plan has to be approved not only by the Study Director, but, as described above, ( if required by national regulation or legislation ) also by the test facility management and/or the sponsor, an amendment has only to be approved by the Study Director, since the GLP Principles require only that they should be justified and approved by dated signature of the Study Director and maintained with the study plan . 

Effort in the immediate future (6-9 months) will focus on completion of the review of current accepted practices and initiation of the definition and design of the test facilities. Visits to a number of leading laboratories in hydrogen storage measurement will be included as part of the review of current practices. 

Definition of Experimental Design and construction of testing facilities... 

---