Requirements for demonstrating safety

Most of the solvents listed in Table 8.4 are volatile at ambient temperature and above. If nonvolatility is required for either safety reasons or for high temperature reactions, veratrole (boiling point temperature, of 206°C), diphenyl ether (r,p = 259°C), and decalin (r,p = 196°C) are recommended." - Another alternative recently demonstrated is the use of ionic liquids. Ionic liquids, typically consisting of nitrogen-containing organic cations and inorganic anions, are readily synthesized,... 

Whilst it is acknowledged that eonpetence plays a very important role in functional safety, it must be taken in perspective. The effort expended in demonstration of conformity to the principles and guidance should be eommensurate to the risk associated with inadequate competence. In general, the effort expended in competence management should be balanced with the effort required for other safety management activities, hardware, software and human factors included. 

Demonstrate that all structures and foundation elements satisfy the ultimate load requirements of the American Concrete Institute (ACI) Code (ACI 349-85, "Code Requirements for Nuclear Safety-Related Concrete Structures", 1985) and the American Institute of Steel Construction (AISC) Code (Manual of Steel Construction, 7th Edition, June 1973), when the design basis event (DBE) (corresponding to the RG 1.60 spectra anchored at 0.2 Gs) seismic loads are combined with the operating loads using a load factor of unity for all load components. 

The final element which regulations address is quality. Safety and fitness for purpose, as discussed above, are two of the characteristics that you would associate with a quality product. However, these characteristics alone would not describe a quality product. For any product or service to be considered quality you would also expect it to be reliable and consistent. Additionally in the context of medical products, quality means a requirement to demonstrate conformance to agreed specifications or applicable standards for content, purity and stability. Many organisations, from manufacturers to service providers, voluntarily apply quality assurance systems in order to more effectively meet their customers needs on a consistent basis. However,... 

Recently, similar legislation has been introduced in the European Union under regulations EC/1901/2006 and EC1902/2006. This requires that marketing authorisation applications for new drugs submitted after the 28 July 2008 must be accompanied by either the results of specific studies demonstrating safety and... 

The computerized systems, both hardware and software, that form part of the GLP study should comply with the requirements of the principles of GLP. This relates to the development, validation, operation and maintenance of the system. Validation means that tests have been carried out to demonstrate that the system is fit for its intended purpose. Like any other validation, this will be the use of objective evidence to confirm that the pre-set requirements for the system have been met. There will be a number of different types of computer system, ranging from personal computers and programmable analytical instruments to a laboratory information management system (LIMS). The extent of validation depends on the impact the system has on product quality, safety and record integrity. A risk-based approach can be used to assess the extent of validation required, focusing effort on critical areas. A computerized analytical system in a QC laboratory requires full validation (equipment qualification) with clear boundaries set on its range of operation because this has a high... 

Fabrication of the prototype is an important step in product development. It demonstrates that the various components can indeed be physically integrated to form the final product with the desired functionalities. Consider a UV sensor. While its functionality depends on the physical response of a certain nanomaterial in the presence of UV light, an electric circuit and a display system are required for a functional consumer product. The availability of a prototype is essential in test marketing, safety tests, reliability tests and so on. However, the development of consumer-oriented products often involves a considerable amount of trial-and-error, which can lead to costly delays in product launching [10]. 

A third type of emergency response plan required for implementation in selected (covered) facilities is OSHA s 29 CFR 1910.120 (Hazardous Waste Operations and Emergency Response—HAZWOPER) for releases of hazardous materials. Unless the facility operator can demonstrate that the operation does not involve employee exposure or the reasonable possibility for employee exposure to safety or health hazards, the following operations are covered ... 

Karyology and Tumorigenicity May be required to test for safety of cell fine for those products with no cells, karyology and tumorgenic-ity not necessary but demonstration of residual host cell DNA is required for those products with presence of live cells, karyology and tumorgenicity required... 

Validation—The activity of demonstrating that the safety-instrumented system under consideration, after installation, meets in all respects the safety requirements specification for that safety-instrumented system. 

Sample sizes for clinical trials are discussed more fully elsewhere in this book and should be established in discussion with a statistician. Sample sizes should, however, be sufficient to be 90% certain of detecting a statistically significant difference between treatments, based on a set of predetermined primary variables. This means that trials utilising an active control will generally be considerably larger than placebo-controlled studies, in order to exclude a Type II statistical error (i.e. the failure to demonstrate a difference where one exists). Thus, in areas where a substantial safety database is required, for example, hypertension, it may be appropriate to have in the programme a preponderance of studies using a positive control. 

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