Testing Considerations

Since the proof-of-principle test, considerable improvements to the BWA monitoring method hardware and software were made by Hamilton Sund-strand Sensor Systems, and they are now being incorporated into LRIP units for the final phase of BWA method work. The BWA monitoring method and... 

While methods validation and accuracy testing considerations presented here have been frequently discussed in the literature, they have been included here to emphasize their importance in the design of a total quality control protocol. The Youden two sample quality control scheme has been adapted for continuous analytical performance surveillance. Methods for graphical display of systematic and random error patterns have been presented with simulated performance data. Daily examination of the T, D, and Q quality control plots may be used to assess analytical performance. Once identified, patterns in the quality control plots can be used to assist in the diagnosis of a problem. Patterns of behavior in the systematic error contribution are more frequent and easy to diagnose. However, pattern complications in both error domains are observed and simultaneous events in both T and D plots can help to isolate the problems. Point-by-point comparisons of T and D plots should be made daily (immediately after the data are generated). Early detection of abnormal behavior reduces the possibility that large numbers of samples will require reanalysis. 

Gulezian, D., D. Jacobson-Rram, C.B. McCullough, et al. 2000. Use of transgenic animals for carcinogenicity testing Considerations and implications for risk assessment. Toxicol. Pathol. 28 482 99. 

Overall, a wide range of testing considerations are needed for new excipient materials, although the actual package of study types still remains a case-by-case approach. 

For all tests, the minimum time between forming the material and testing shall be 16 h. When test pieces are cut from products or where whole products, e.g. bridge bearings, are tested, considerably more than 16 h may be necessary. In these cases, the minimum time shall be given in the product specification and/or relevant test method. 

It may be possible to increase the sensitivity of testing considerably and thereby decrease the number of tests and the corresponding cost by using repair-deficient mutant strains. Several laboratories are engaged in validating these systems for the sex-linked recessive-lethal test. 

Great variation exists both in production of chemicals of commerce and in their potential for important human exposure. Although one could suggest with some justification that chemicals produced in the largest quantities require the most thorough toxicity testing, considerable health effects can be associated with chemicals produced in small quantities (e.g., some drugs and food additives) and chemicals that occur primarily as natural substances... 

First consider an analytical run and the capacity test considerations that will need to be evalnated. The maximum number of vials to be injected in a single run should be derined in the URS. Testing should include standards, samples, quality control, and blank reagents that are to be used as part of normal working procedures. A test should be designed to run the maximum samples including replicate injections. 

Once the cause of the problem has been located in Step 7, it is valuable to confirm this identification. It may be necessary to analyze data from additional batches or to run a confirming use-test. Considerable resources (and professional reputations) are at risk if large-scale operations are resumed based on hasty conclusions. 

In developing optimum concentrations of smoke components needed for colour development on a specific product, it is first necessary to run a series of small-scale tests with the selected smoke flavouring to be used for a specific product. In performing the tests, consideration should be given to length of dip time and smoke component concentration as both can affect colour intensity. Once the concentration of components in millilitres per kilogram (ml/kg) of product is established, they can be scaled up to production levels. 

Gulezian, D., Jacobson-Kram, D., McCullough, C. B., Olson, H., Redo, L., Robinson, D., Storer, R., Tennant, R., Ward, J. M., and Neumann, D. A. (2000). Use of transgenic animals for carcinogenicity testing Considerations and implications for risk assessment. Toxicol Pathol 28, 482—499. 

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