Test System Facilities

Of eminent importance are the facilities that are used for the housing or siting of test systems. Some of the requirements dealing with test system facilities have already been addressed above, especially those that are concerning the technical side of the issue. In this section the more organisational 

The sad experience with the conditions at IBT, where multiple studies were run simultaneously in the same room with the concomitant problems of mix-ups of animals and treatment cross-contamination by volatile test substances, have resulted in the requirement of sufficient space to assure the isolation of test systems . Through a sufficient number of rooms or at least sufficiently separable areas, it should become possible to avoid any crosscontaminations or mix-ups of projects, tests or treatments. Also the positioning of test systems used in field studies requires an appropriate degree of separation, as it is specified in the GLP Principles ( Test systems used in field studies should be located so as to avoid interference in the study from spray drift and from past usage of pesticides . In the same sense, isolation of individual projects in aquatic toxicity testing should be applied to the extent necessary, to prevent cross-contamination through spray, mist or overflow. 

Isolation does, however, not mean that access to the test system or their housing or treatment localities generally needs to be restricted, save in some special circumstances, and apart from what would be dictated by sound scientific reasons. An example in case would be the restrictions for the access to certain animal facilities Because of special requirements, e.g. because of a specific pathogen-free or even sterile environment, access to these may have to be limited to authorised persons only. 

A study will yield valid results only, if the respective test system has been properly located or housed. Its integrity will also critically depend on the proper separation from other studies, and the respective requirements aim at minimising not only the potential for mistakes but also the occurrence of reciprocal disturbances. In this sense all conditions or situations which might lead to untoward influences on the study in progress will have to be taken care of through the adequate design and lay-out of the respective facilities. 

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The company has extensive processing, analytical and testing laboratory facilities and expertise, and produces a range of engineering and data management software products, and computerised knowledge-based systems. 

Testing facility (both EPA and FDA) A person who actually conducts a (nonclinical laboratory) study, i.e., who actually uses the test substance (article) in a test system. 

Adhesion tests can be broken into two categories qualitative and quantitative. They vary from a simple Scotch tape test to a complicated flyer tape test, which requires precision-machined specimens and a very expensive testing facility. Quantitative (such as peeling) tests have been developed for coatings on plastics (12), but not to the same extent for metal-to-metal systems. The quantitative testing systems in limited use, mainly in the electronics industry, are not commonly present in production plants but have been used to aid in process development. For quality control purposes, qualitative tests for metal-to-metal adhesion (13) are usually adequate. The adhesion of some plated metal parts is improved with baking for 1 to 4 h at relatively low (120 to 320°C) temperatures. 

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. 

Animal care facilities 160.43 Test system care facilities... 

Animal supply facilities 160.45 Test system supply facilities... 

Maintain a copy of a master schedule sheet of all nonclinical laboratory studies conducted at the testing facility indexed by test article and containing the test system, nature of study, date study was initiated, current status of each study, identity of the sponsor, and name of the study director. 

The final portion of the GLP surveiUance inspection includes examination of records and reports as described under Parts 58.185, 58.190, and 58.195. To accomphsh this, FDA assesses the fachitys ability to store and retrieve study data, reports, specimens, and so on in a manner that maximizes their integrity and utihty. This must include an overview of how the firm maintains materials such as the raw data and the various specimens that are developed in the course of the study. The investigators must become famihar with the facility s archives regarding their location and accessibility. The individuals responsible for the archives must be identified and FDA must learn whether or not the archive is indexed and if the materials and records that have been transferred and stored elsewhere are appropriately identified. Furthermore, the procedures for adding or removing materials from the archives must be examined and individual test systems are selected randomly to determine that all raw data, specimens, and documents have been retained as required. 

The design flowrate of the pilot-scale test system is 10 gph or 900 L/day, which is adequate for small quantity generators, or a slip stream from a higher capacity operation could be used. Once onsite testing is completed, the system may be transported to an operating facility for demonstration testing. The test system will be constructed in four modules to simplify transportation. When the modules are prepared for shipment, only Interconnected piping will need to be separated and capped. 

The Prudhoe Bay facilities could not have been operated with the flexibility and precision that currently exists without the benefit of the centralized control and monitoring facility that a SCADA system and computer provide. This is particularly true of the unique production allocation, production control and well testing system. 

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 ... 

Current Animal care facilities Proposed Test System care facilities Section 160.45... 

Current Animal supply facilities Proposed Test system supply facilities Section 160.90... 

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. 

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