Facilities laboratory operation areas

Facilities for handling test and control articles Laboratory operation areas Specimen and data storage facilities Equipment design... 

Food and Drug Administration investigators found generally acceptable performance in the archival and record retention areas as well as in the area of the physical facilities associated with animal care and laboratory operations. The lack of findings in these areas is encouraging, since it may be... 

While it may thus be possible that in certain areas, the different quality systems may be similar to one another, it has nevertheless to be recognised that neither the adherence to an ISO or accreditation standard may replace GLP compliance (for this aspect see the respective OECD Position Paper), nor can a GLP compliant test facility claim the same technical competence as a laboratory operating under an accreditation scheme. However, the existing redundancies in the different sets of rules can make it possible to implement two such quality systems in one laboratory utilising the common points of the two systems to facilitate the tasks of personnel and quality management. The same can be true for the official compliance monitoring inspections and audits, where audit or inspection results of aspects that are fully covered by one system may be accepted by the other without further investigation. 

The facility should have a separate room for storing radioactive standard and stock solutions. This room usually is located near the sample receiving and processing area. Radioactive standards and solutions must be kept separate from other laboratory operations to prevent cross-contamination. The room should have cold storage capabilities and lockable cabinets. It should be designed to the same specifications as other sample preparation rooms, with a fume hood and computer access to permit dilution and other processing of radioactive standard reference materials and stock solutions. 

The facilities at Savannah River(j)) consist of five heavy-water-moderated and cooled production reactors, two chemical separations areas as a heavy water extraction plant, several test reactors, reactor fuel and target processing facilities, the Savannah River Laboratory, and many other facilities necessary to support the operations. During the 1960 s, two of the... 

Parts 58.41 through 58.51 cover the physical facihties of the laboratory. The inspector must determine whether or not the facilities are of adequate size and design for completed or in-process studies. The physical parameters and systems of the facilities as they are used to accommodate the various operations employed in the GLP studies are examined. Investigators also deal explicitly with the environmental control and monitoring procedures for critical areas, especially the rooms used for animal housing, the test article storage areas, and the laboratory areas in which biohazardous material is handled. The procedures and methods for cleaning equipment and areas critical to study conduct as well as the cur-... 

Phase 5 Multiple CPUs And Intelligent Laboratory Devices On The Network. Computer manufacturers have developed systems with multiple CPUs and multiple operating systems (i.e. A Network). The construction of networks comprised completely of intelligent laboratory devices is a real possibility with the availability of the Ethernet Specification. Small local area networks of laboratory deices will develop using Ethernet and other technologies. Later these local networks will be interconnected probably via routers and gateways to broadband, Satellite, and telephone facilities. 

The service and support area, centrally located in the main building, provides for operational control and support functions such as surveillance, decontamination facilities, utility and environmental systems and chemical laboratories. 

---