INDEX safety organizations

Like VDA 6.1, AVSQ 94 does not include the requirements of ISO 9001. In this way issues of copyright are overcome, a practice shared by VDA and EAQF but not QS-9000. However, unlike VDA 6.1, AVSQ 94 follows the 20 elements of ISO 9001 with two additional elements, covering financial considerations and product safety. Those questions that go beyond ISO 9001 are marked and as every question is numbered it simplifies the evaluation process. A scoring method is employed to classify organizations in terms of a conformity index. Each question is awarded a point (0, 2.5, 5, 7.5, or 10), where 10 points means full compliance, 7.5 points means minor inadequacies, 5 points means inadequacies in application requiring improvement, 2.5 points means serious inadequacies in application, and 0 points is used for criteria not applied. Unfortunately all questions carry the same weight as no account of the impact of omission on product quality or customer satisfaction is included. 

On the GM debate and biosafety research, a review of results performed under the European Commission supervision ( EC-sponsored Research on Safety of Genetically Modified Organisms , edited by C. Kessler and I. Economidis) is available also online at the EU-website http //europa.eu.int/ comm/research/quality-of-life/gmo/. An update on current research in food safety, nutrition and food-related disease might be found in the websites of the World Health Organization, http //www.who.int/fsf/GMfood/index.htm, and of the UK Food Standards Agency, http //www.foodstandards.gov.uk/. 

In the past, several terms have been coined to describe the retention efficiency of the filter system beta value, microbiological safety index, reduction ratio, and titer reduction ratio [64,68,72], The log reduction value (LRV) is a filter retention efficiency term that is the logarithm to the base of 10 of the ratio of the number of organisms in the challenge suspension to the number of organisms in the filtrate. 

Toxicology studies are conducted to define the safety profile of a candidate and include definition of the no-toxic-effect dose, MTD, potential organs of toxicity, and potential biochemical markers to detect and track toxic events. Most developmental compounds that do not become therapeutic products have unacceptable toxicity in animals or humans. Before the definitive toxicology studies needed to support an IND submission are initiated, a number of animal experiments can be conducted to characterize the potential toxicity of the candidate. These early toxicology evaluations are usually conducted in the same species as used in pharmacology evaluations. As mentioned earlier, the lowest dose that has no toxicity or an acceptable level of toxicity is compared with the dose that gives the desired pharmacologic response in the same animal species to obtain a therapeutic ratio or index for that species. 

Certainly, most in vitro assays cannot predict (a) metabolite effects, (b) adverse effects associated by accumulation, and (c) drug actions at targets with mutations. Nevertheless, early safety-profiling assays have the power to detect trends toward certain adverse reactions and organ toxicity and to navigate drug discovery teams away from them. The major difficulty is estimating the impact of the data on the clinical performance determined by the human therapeutic index. 

Environmental Health Criteria 165 — Inorganic Lead, International Programme on Chemical Safety, World Health Organization, Geneva, Switzerland, 1995. http //www.osha-slc.gov/SLTC/etools/leadsmelter/index.html... 

International Chemical Safety Cards (ICSCs). Geneva, Switzerland International Labour Organization, http // www.ilo.org/public/english/protection/safework/cis/ products/icsc/index.htm (accessed on March 1, 2006). 

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