Monitoring test facility

Sliop test facilities should include instrumentation with the capability of continuously monitoring and plotting rpm, peak-to-peak displacement, and phase angle (X-Y-Y ). Presentation of vibration displacement and phase marker by use of an oscilloscope makes visualization easier. 

If the test facility claims to be GLP-compliant but is located in a country where there is no authorised body responsible for GLP monitoring, i.e., a national GLP compliance program, the Study Director needs to be assured that the facility (including the archive, if used) does operate in compliance with GLP principles. This can be achieved by conducting a pre-study QA test site inspection or by a review of documentary evidence, e.g., notice of adverse findings and subsequent responses, or Establishment Inspection reports. The Study Director should ideally discuss the above with QA personnel and send copies of any documentary evidence used to the Quality Assurance Unit (QAU) for inclusion in the QA multi-site study file. 

Test Facility QA personnel and test site QA personnel should sign and date QA statements detailing any monitoring that they carried out. 

In addition, previous studies have been conducted that monitored the performance of ET covers. Selected studies include the following integrated test plot experiment in Los Alamos, New Mexico, which monitored both types of ET covers from 1984 to 198786 Hill Air Force Base alternative cover study in Utah, which evaluated three different covers (RCRA Subtitle D, monolithic ET, and capillary barrier ET) over a 4-year period87 and Hanford field lysimeter test facility in Richland, Washington, DC, which monitored ET covers for 6 years.88... 

GLP is a managerial concept covering the organizational process and the conditions under which laboratory studies are planned, performed, monitored, recorded, and reported. Its principles must be followed by test facilities carrying out studies to be submitted to national authorities for the purposes of assessment of chemicals and other uses relating to the protection of man and the environment. 

It also comprises reporting and internal market (= mutual acceptance of data) requirements. The directive requires that the OECD Revised Guides for Comphance Monitoring Procedures for GLP and the OECD Guidance for the Conduct of Test Facility Inspections and Study Audits must be followed during laboratory inspections and study audits. 

The Aimex I of the Directive 2004/9/EC consists of two parts Part A (Guides for compliance monitoring procedures for good laboratory practice) and Part B (Guidance for the conduct of test facility inspections and study audits). The provisions for the inspection and verification of GLP which are contained in Parts A and B are those contained in Annexes I and II respectively of the OECD Council Decision-Recommendation on comphance with principles of good laboratoiy practice. 

Good Laboratory Practice is a qnahty system concerned with the organisation of the test facility and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported. This is the GLP Decalogue stating the basic principles that the laboratory must follow. 

The Government of India has established the National GLP Compliance Monitoring Authority (India GLP), adopting the OECD quality system of the principles of GLP, for inspection, monitoring, and accreditation of test facilities in India for conducting nonclinical and environmental safety studies. Currently, India enjoys the full member status of OECD for GLP. India is a member of the OECD Test Guidelines program. 

Currently 23 Indian laboratories have been accredited by the Indian national GLP compliance monitoring authority as per the provisions of the OECD Principles of GLP to conduct nonclinical health and environmental safety studies. The Indian system of GLP inspection, accreditation, and monitoring of test facilities was started in 2004 (India GLP). 

The proposed regulations went beyond these basic requirements for a valid study by requiring each study to have a study director who would have ultimate responsibility for implementation of the protocol and conduct of the study [ 3e/31(a)], and each testing facility to have a quality assurance unit to monitor conduct of studies. The concept of a quality assurance unit to monitor study conduct was a new one to most laboratories but a familiar one in manufacturing facilities operating under various GMP regulations. 

Initial planning under the Bioresearch Monitoring Program called for each testing facility to be inspected yearly. It was later decided that a biennial inspection would suffice to ensure that all 2-year studies would be inspected at least once while in progress. 

The data of the microbiological monitoring of the sterility testing facility show a fault. 

A facility for the testing and/or type-approval of continuous industrial emission-monitoring (CEM) instrumentation has been established. This is a comprehensive laboratory-based calibration and test facility which is pri-... 

The NPL testing facility is used to perform all the laboratory tests specified within the Environment Agency s MCERTS Scheme for CEM systems. This MCERTS Scheme is to be extended to cover ambient air quality monitoring instrumentation particularly that required within the EC Air Quality Framework and Daughter Directives, in the near future. 

Ultraviolet spectrophotometry (DuPont 400 SO2 analyzer) was used to monitor the gas phase SO2 concentrations and SO2 removal efficiencies. The pH of scrubbing liquor in each reactor was measured hourly during pilot testing. Solid dewatering properties were characterized by hold tank slurry settling rate and filter cake insoluble solids concentration. Detailed descriptions of the test facilities and analytical procedures were reported earlier(S). 

In 1989, the OECD Council adopted an Act on Compliance with Principles of GLP. This Act contains a Decision that member countries shall (1) establish national procedures for monitoring compliance with GLP Principles, based on laboratory inspections and study audits (2) designate national compliance monitoring authorities ( CLP inspectors ) and (3) require the management of test facilities to issue a... 

Acceptance criteria can be defined as the list of requirements that must be satisfied prior to the user accepting delivery of the product, where the product refers to the in vitro method and the user to the validation body, the regulatory body, or an end-user s test facility. Acceptance criteria should be defined for key components of the test method such as the in vitro test system and the endpoint measurement. For defining such criteria the in vitro test system must have a specific functionality, which can be measured. Examples of acceptance criteria for endpoint measurements are linearity or limit-of-detection. An example of an equipment requirement is balance or pipette sensitivity. Acceptance criteria are used to assess the functioning of the in vitro method and/ or of various stages/parameters of the method. These need to be defined up front so that performance of the in vitro test system can be monitored on a regular basis. 

Still another approach was the establishment of a fulltime, on-site inspection program for laboratories similar to the U.S. Department of Agriculture s inspections of meat-processing plants. Such a program was considered to be an inefficient use of the FDA s investigational resources, because many testing facilities are too small or too diversified to justify full-time, on-site monitoring. 

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