Indicators development guidelines

CCPS has developed guidelines for the measurement of PSM performance that provide useful ideas on measurement. Their approach for developing performance measures integrates Quality Management with a well-tested methodology for developing measures based on mathematical algorithms derived from expert assessment of system performance. The purpose was to identify well-defined, measurable, and practical indicators of performance that are updated on a schedule which makes the performance measure continuously useful. To date, measures have been developed for... 

Several countries (Cyprus, Estonia, Venezuela and Zimbabwe) have adopted the WHO GMP guidelines (25) as their statutory GMP standards. Australia has its own GMP guidelines. Malaysia uses the GMP guidelines of the ASEAN (26). The Netherlands has adopted the European Union guidelines on GMP inspection (27). The majority of the countries have also developed SOPs for their inspectors, as indicated in Table 7.1. Australia, Cuba, Cyprus, Malaysia, Uganda and Venezuela have not developed guidelines for GDP. 

Submission of the application must be on grant application form PHS 398, as noted above. An excellent guide entitled How to Write a Research Grant Application has been prepared by the government, and is available on request. The FDA has indicated that guidelines will be maintained and a request for the list or for any guideline should be directed to the Office of Orphan Products Development (HF 35), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857 (8). 

United Nations Commission on Sustainable Development, Indicators of Sustainable Development Guidelines and Methodologies, United Nations, 2001. Available at http // www.un.org/esa/sustdev/natlinfo/indicators/isdms2001/isd-ms2001isd.htm. 

The development of worst-case scenarios is certainly subjective, but government agencies and organizations develop guidelines for this task. For example, there is certainly a chance that an asteroid will inpact Earth direcdy in the middle of the chemical plant. Should this be the worst-case scenario Most people would argue that this takes the worst-case scenario study beyond reason, but there are no clear-cut rules. The subjective rules that have been developed contain definitions such as the worst accident that might reasonably be assumed possible over the life of the facility. Different people would define possible (or probable ) in different ways. Is sabotage by an enployee possible Is the simultaneous failure of three independent safety systems probable Certainly the events of September 11, 2001, have indicated that a terrorist-attack scenario is not inpossible. Sometimes probabilities of occurrence can be estimated, but often they cannot. 

Extrapolating exposure estimates to all urban cities In the world would Indicate that as many as 625 million people, mostly In developing countries, are exposed to unacceptable levels of 02 pollution and about 1.25 billion people live In urban areas where SPN levels exceed acceptable guidelines. This means that less than 20 percent of city dwellers live In environments that can be considered to have acceptable outdoor air quality levels. 

Although the present results are only theoretical and not yet verified by experiments, it is felt that this approach, although very much simplified with respect to practice, can be used at least as a qualitative guideline in choosing new experiments for product development. These results are therefore useful in a qualitative sense to show sensitivites, trends and directions. Experimental verification may improve the applicability to (semi-)quantitative predictions, or indicate shortcomings in the present approach, which may be accordingly adjusted. 

Current NKF guidelines define anemia as a hemoglobin (Hgb) level less than 11 g/dL (6.8 mmol/L).31 A number of factors can contribute to the development of anemia, including deficiencies in vitamin B12 or folate, hemolysis, bleeding, or bone marrow suppression. Many of these can be detected by alterations in RBC indices, which should be included in the evaluation for anemia. A complete blood cell count is also helpful in evaluating anemia to determine overall bone marrow function. 

In the earliest development pharmaceutics guideline it was indicated that development pharmaceutics studies may be needed to support a marketing authorization application. Subsequent documents have made it clear that such data will be expected to form part of the application. 

Source U.S. EPA, Development Document for Effluent Limitations Guidelines and Standards for the Porcelain Enameling Point Source Category, Washington, DC, 1982 U.S. EPA, Porcelain Enameling Point Source Category, 2008. Dashes indicate data not available. 

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