The regulatory body

The operating organization should ensure that MS I for SSCs important to safety are of such a standard and frequency as to ensure that the level of reliability and functionality of the SSCs remains in accordance with the design assumptions and intent throughout the plant s operating lifetime. 

The extent of the regulatory body s involvement in MS I activities at nuclear power plants will depend on the practices in the State concerned. In general, the regulatory body s main concern will be to ensure that all such activities are properly conducted, particularly for SSCs important to safety. In most cases, the regulatory body may be involved in the following activities as a minimum  

The operating organization should ensure that an effective organization is established for MS l, which should perform all the administrative, technical and supervisory functions necessary in mobilizing and supervising on-site and off-site MS l resources. The management at the plant is required to remain responsible for all tasks undertaken on its behalf [1]. 

Contractors should be subject to the same standards as plant staff, particularly in the areas of professional competence, adherence to procedures and evaluation of 

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In addition to the formal committees specified in directives, the commission is assisted by other expert committees and working groups. Depending on the subject matter, these can be drawn from the regulatory bodies, the scientific community, or industry and end-user associations. 

The approved color additives appear on positive lists issued by the Food and Drug Administration in the US, the EU, and Japan, but the colorants permitted in each market vary considerably. US and EU regulatory organizations provide provisional and permanent lists of approved color additives. The permanently listed additives are considered safe for use in cosmetic and toiletry products by the regulatory bodies. Provisionally listed color additives are those on which some safety studies are still to be undertaken or their test results are under review. The Japanese regulations include only a permanent list of color additives. 

The use is examined of plastics in medical applications with reference to the US market for additives for these products. The use of plastics for medical applications, which include products and components of equipment, and packaging, is expected to exceed 4 billion US dollars in the next two years, with perhaps double or treble that figure for the world market, it is forecasted. The regulatory bodies governing the use of additives are reviewed, and specific additives discussed include plasticisers, stabilisers, conductive additives, and lubricants. The production of compounds for use in the medical sector is examined with reference to the activities of leading companies, and brief details of product developments are included. 

E should be investigated by the regulatory body and, if necessary, the drug should be withdrawn prior to informing the marketing authorisation holder... 

The Summary of Product Characteristics (SPC) for a medicinal product reflects the information in the marketing authorisation of the product. It is prepared by the manufacturer and is intended for health professionals. Updates are necessary to reflect any approved changes by the regulatory body in the marketing authorisation. 

Nondinical assessment of cardiac safety must be performed for a compound to qualify to be submitted to the health authorities to begin studies in man. For this purpose the regulatory bodies require that the cardiosafety assays should follow the principles of GLP wherever possible. The following assays/technologies are frequently used to predict potential clinical QT liability. 

The Pharmaceuticals and Cosmetics Division (Koseisho) of the Pharmaceutical Affairs Bureau of the Ministry of Health and Welfare (MHW) is the regulatory body in Japan. Also in Japan there have been clear changes in the drug approval system, mainly inspired by ICH. One of the most important recent changes is that, under certain conditions, it is now possible to use also foreign data for the approval of new dmgs in Japan. 

An alternative and increasingly applied approach, particularly from the regulatory bodies, is from the other direction, i.e. top down . This approach is known as the 4Qs model, DQ, IQ, OQ and PQ which are ... 

From a regulatory perspective, the most important document is the validation report. This is because the report is typically the first document that a regulatory agency will review. If the validation report is error-free and complete, the regulatory body has no need to investigate further. Awell-written validation report should include the following three essential items. 

The regulatory body that conducts a postapproval GMP inspection will submit its report to the authority of the importing country within 60 calendar days of the request [29], If a new inspection is necessary, the inspecting body will provide its report within 90 calendar days of the request [30], Reports of PAIs will be sent to the requesting authority within 45 calendar days of the request unless an exceptional case arises [31]. 

The source of food is selected and the manufacturer audited against the supermarket and the regulatory bodies standards. Food is ordered in advance of the chick delivery so that the food hoppers or track are filled and awaiting the arrival of the chicks. 

From Table 2 it is seen that ultra-low-emission vehicles (ULEV) will have to meet 0.04 g nonmethane hydrocarbons per mile traveled compared to 0.25 g per mile in 1993. In contrast, the CO and NOx emissions will only halve between 1993 and ULEV standards. While this does not mean that the CO and NOx standards are easily achievable, it highlights the greater importance attnbuted to the control of HC by the regulatory bodies in the United States. Similarly, the European standards for hydrocarbons are promulgated to reduce progressively at each stage of the legislation. In addition, for the first time the... 

Radioactive waste is any material that contains, or is contaminated with, radionuclides at concentrations of radionuclides greater than the exempted quantities established by the regulatory body and for which no future use is foreseen. This is after a definition by IAEA. 

Safety Series No. 50-SG-G4 (Rev 1) Inspection and Enforcement by the Regulatory Body for Nuclear Power Plants (1996). 

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