Standards for goodness

Development and application of a standard for good assessment practice The quality of risk assessments and risk management information could become an element of competition in the global market. To this end an anditable and internationally recognised standard is reqnired. 

A process that was no more than a laboratory phenomenon when the Office of Saline Water was authorized in 1952 has been rapidly developed to the point where it is now one of the most economical processes for the conversion of brackish water to fresh. This process, electrodialysis, was selected for the third demonstration plant. It will be located at Webster, S. D. The Bureau of Reclamation Laboratories in Denver, Colo., prepared the specifications for this plant which will be designed to produce 250,000 gallons of fresh water per day. Operating on water containing between 1500 and 1800 parts of salt per million parts of water, this plant will remove more than 1 ton of salt daily to produce product water with less than 500 parts of salt per million parts of water which is required to meet U. S. Public Health Standards for good drinking water. Construction specifications for this plant were available August 1, and sealed bids will be opened on October 4, 1960. 

The use of double-blind randomized clinical trials has become the gold standard for good clinical research. However, it is not always possible to mask the treatments. A trial designed to compare the effectiveness of two surgical procedures, for example, cannot be blinded. Another example is a trial comparing an intravenous drug to an oral drug. In principle, one could blind such a trial by... 

Has been manufactured properly by complying with USP and proposed FDA standards for good manufacturing practices (GMPs). 

Based on Step 4 of the ICH Good Clinical Practice (GCP) guideline of May 1996, the Japanese Ministry of Health and Welfare (MHW) prepared an amendment to the previous GCP guideline and on 27 March 1997 this was issued as MHW Ordinance of the Standards for Good Clinical Practice . This new GCP became effective as of 1 April 1997 with some moratoria (preparation of standard operating procedures (SOP) at medical institutes, source data verification, etc.), and full implementation was from 1 April 1998. Unlike the previous GCP guidelines, the new GCP is based on the revised Pharmaceutical Affairs Law of June 1996, which requires... 

DIOGENES also provides access to many other FDA regulatory documents related to quality control and standards for good manufacturing or laboratory practices. These will be discussed in greater detail later in this chapter. 

Standards for Good Manufacturing and Quality Control of Drugs Italian Pharmacopoea, IX edition... 

Achievement of mass balance (i.e., complete recovery of administered dose) is an important part of the first goal listed above. Incomplete recovery can lead to questions about missing elimination pathways and subsequent incomplete understanding of the drug s disposition. The typical standard for good... 

Many component parts are manufactured in accordance with the industrial standards for good system compatibility and part interchangeability. The most notable example are the standards for the bolts, nuts, and other fasteners. The diameter, type of thread, and length are all well standardized. Tables 7.2 and 7.3 summarize a few sample standards of the metric screw threads and the unified screw threads, respectively. Both systems adopt the... 

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