Documentation criteria

For each toxicological endpoint as well as for toxicokinetics, relevant guidance documents, criteria documents, and evaluations from international bodies are mentioned. 

Where the tasks will be performed How the tasks will be defined as successful Documentation criteria Approval criteria Method transfer Definition of method(s)... 

NIOSH recommendations are published in a variety of documents. Criteria documents recommend workplace exposure limits and appropriate preventive measures to reduce or eliminate adverse health effects and accidental injuries. 

Plastics used in the construction of a product must meet the relevant flammability ratings, such as V-2 for PCBs and V-1 for enclosures. In this case, a plastic that has been tested and rated by a North American agency (UL/CSA) according to the relevant flammability requirements of the standards may be acceptable. Consult an EU testing body for their acceptance and documentation criteria (see Figure 6-4 for CDF and Figure 6-3 for critical components examples). 

Criteria and Guidelines for the Accreditation of Biomedical Engineering Programs in Europe, www.biomedea.org/Documents/Criteria%20for%20Accreditation%20Biomedea.pdf... 

Recalling that the Commission, in its PC-XI/17, paragraph 7.2, adopted the document Criteria for Acceptable Performance of Laboratories in Proficiency Testing ,... 

Since property damage or personal injury may result from accidents, testing following an accident can help determine whether drugs and/or alcohol were a factor. It is important to establish objective and documented criteria that will trigger a post-accident test. 

World Anti-Doping Agency (2004) Identification Criteria for Qualitative Assays Incorporating Chromatography and Mass Spectrometry. Available at http //www.wada-ama.org/rtecontent/document/criteria l 2. pdf. Accessed 07-27-2006. 

A SW verification corresponds to documentation criterion if all plans and reports reflected verification process and results in details was issued. 

Combination of Eq. 7 or Eq. 8 with the Young-Dupre equation, Eq. 3, suggests that the mechanical work of separation (and perhaps also the mechanical adhesive interface strength) should be proportional to (I -fcos6l) in any series of tests where other factors are kept constant, and in which the contact angle is finite. This has indeed often been found to be the case, as documented in an extensive review by Mittal [31], from which a few results are shown in Fig. 5. Other important studies have also shown a direct relationship between practical and thermodynamic adhesion, but a discussion of these will be deferred until later. It would appear that a useful criterion for maximizing practical adhesion would be the maximization of the thermodynamic work of adhesion, but this turns out to be a serious over-simplification. There are numerous instances in which practical adhesion is found not to correlate with the work of adhesion at ail, and sometimes to correlate inversely with it. There are various explanations for such discrepancies, as discussed below. 

This criterion was based on experience in the past with designing our own GPC columns and has been documented in the open literature (4,5). We found that it was very important in obtaining a column that was very efficient and had high resolution to have the beads as narrow in size distribution as possible. 

The fourth criterion asks to transparency. This is reasonable, since all documentation on the basis of the assessment of the properties of a chemical should be clearly available and checkable. One of the driving forces of REACH was to have the correct knowledge on the properties of the chemical substances on the market. If some of the information is hidden, this clearly goes against the spirit of REACH. 

The Sponsor has to explain how the drug is to be manufactured, tested, and stored. TTie important criterion is to ensure that it is safe for the subjects of the clinical trials. The CMC is a living document it is updated as the clinical trials proceed from Phase I to Phases II and III and eventually to a licensed... 

Until 1994 the EPA regulated pesticides proposed for use on food crops under certain sections of the Food, Drug, and Cosmetics Act. Carcinogenic pesticides were subject to the Delaney clause, and were thus prohibited. The use of a non-carcinogenic pesticide was allowed if its manufacturer provided data sufficient to establish an RfD, and information on expected food residue levels sufficient to document that the RfD would not be exceeded when people consumed food containing residues of the pesticide. The tool for determining compliance with this criterion is called a tolerance, and it is expressed as the maximum amount of a pesticide that can be present in a given amount of food, if the RfD is not to be exceeded. 

Conclusion All parameters during heat distribution are meeting the acceptance criterion and determine the coolest point of the tunnel. For supporting documents, e.g., Kaye validator prints, calibration of thermocouples (before and after the study). 

Case A The required documentation must include the undertaking of the technical report and assessment of the results of the dissolution test, carried out as described in the Brazilian Pharmacopoeia and, in its absence, other codes authorized by the legislation in force. There must be dissolution of at least 85% of the active substance in up to 15 minutes, using 900 ml of HC1 0.1 M. In case this criterion is not complied with, the tests described for Cases or C must be carried out. ... 

The CCRVDF should review the procedure for establishing priority lists of substances to be evaluated by the JECFA. One criterion for including a candidate substance on the priority list is that all the necessary information be made available to the JECFA, but this condition can only be met by the veterinary pharmaceutical industry because of the growing complexity of tlie documentation. As a result, the JECFA works on the basis of CCRVDF priorities that are heavily influenced by industry decisions. 

Proposing this new criterion in a document like the Declaration of Helsinki implies a policy that should rule all research being done. Note that the Declaration of Helsinki is "the" ethical code. It morally binds all researchers and should be abided by research ethics committees when evaluating protocols and sustained as a requirement when publishing an article. Hence, changing the standard of care in such a document would have a profound impact on research. It would imply a new normative criterion for all research. 

Finding 4-2. One specific criterion for evaluating the modified baseline design, as documented in the NEPA notice of intent for Pueblo, is that the facility be as safe as baseline incineration. Because of the very low risk at Pueblo, it is not clear how this and other criteria can be implemented. 

Finding 4-2. One specific criterion for evaluating the modified baseline design, as documented in the NEPA notice of... 

A more robust system would incorporate markup language information inside the XML documents for selection purposes. The name of a root element is a convenient selection criterion, but only if every markup language uses unique root elements. If there were only several languages around, it would not be a difficult problem, but given the diversity of the Internet, such uniqueness is impossible to achieve. 

Crack growth models in monolithic solids have been well document-ed. 1-3,36-45 These have been derived from the crack tip fields by the application of suitable fracture criteria within a creep process zone in advance of the crack tip. Generally, it is assumed that secondary failure in the crack tip process zone is initiated by a creep plastic deformation mechanism and that advance of the primary crack is controlled by such secondary fracture initiation inside the creep plastic zone. An example of such a fracture mechanism is the well-known creep-induced grain boundary void initiation, growth and coalescence inside the creep zone observed both in metals1-3 and ceramics.4-10 Such creep plastic-zone-induced failure can be described by a criterion involving both a critical plastic strain as well as a critical microstructure-dependent distance. The criterion states that advance of the primary creep crack can occur when a critical strain, ec, is exceeded over a critical distance, lc in front of the crack tip. In other words... 

Multi-criterion analysis is a decision-making tool for qualitative weighting of aggregated impact assessment indicators. Further information is available in the OECD Technical Guidance Document on the use of Socio-economic Analysis in Chemical Risk Management Decision-Making [510]. 

A random sample means that every item in a population has an equal chance of being chosen. Simply choosing materials by eye does not satisfy this criterion. Each of the dose units should be assigned a number, starting at 1 and ending with the last number (i.e. the number of items in the sample). The materials to be chosen should then be picked by using either a computerized random-number generator or random-number tables. Whichever method is used, it should be documented. 

One criterion for vendor qualification should be whether the vendor has a documented Quality Assurance program that follows recognized quality standards, for example, ISO 9001. This registration is usnally snfficient for those laboratories that must comply with ISO 9001 or with a laboratory accreditation standard snch as ISO 17025. However, it is the author s experience that... 

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