Regulatory requirements and guidelines

Drinking water quality should be taken into account from a human toxicological viewpoint because the main source of drinking water is river water. Japanese regulatory procedures allocate 10% of the acceptable daily intake (ADI) in principle to the intake from drinking water. 

Monitoring studies in the actual fields are not required because Japan has no provisional registration system. Most companies, however, have been voluntarily monitoring their chemicals in river water after distribution. 

Ecotoxicological data based on Organization for Economic Cooperation and Development (OECD) guidelines are also required, and the endpoints for aquatic organisms, such as fish, daphnia, algae and aquatic plants, are needed for utilization as part of the risk assessment process. 

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This paper provides an overview of SOPs including regulatory requirements, and guidelines for establishing and maintaining a system of SOPs. 

This appendix discusses the main FDA regulatory requirements and guidelines apphcable to computer systems performing regulated operations and their interpretation. The following regulations are covered ... 

The FDA is announcing the Agency s policy on the development and use of standards with respect to international harmonization of regulatory requirements and guidelines. Specifically, the policy is intended to address the conditions under which the FDA plans to participate with standards bodies outside of the FDA, domestic or international, in the development of standards applicable to products regulated by the FDA. The policy also covers the conditions under which the FDA intends to use the resultant standards, or other available domestic or international standards, in fulfilling its statutory mandates for safeguarding the public health. 

The purpose of this document is to articulate the FDA s policy on development and use of standards with respect to international harmonization of regulatory requirements and guidelines. As used throughout this document, the term standards includes what are commonly referred to as consensus standards, voluntary standards, and industry standards. Also, the FDA sometimes accepts standards and makes them mandatory regulatory requirements. Although the draft policy focuses on international harmonization and international standards, its principles are applicable as well to domestic standards activities in which the FDA participates. 

M.M. Hirschler (Technical Coordinator) et al., Fire and Transportation Vehicles—State of the Art Regulatory Requirements and Guidelines—A White Paper, Fire Protection Research Foundation Research Advisory Council on Transportation Vehicles, Quincy, MA, October, 2004. 

Apart from compliance with SOPs for biostatistics and report writing, the statistical analysis plan, the trial protocol, regulatory requirements and guidelines (ICH E3, 1995 ICH E9, 1998 ISO 9000 2005, 2005), QA auditors check the internal consistency of the trial report and appendices and between data in tables, figures and graphs and numbers cited in the text. All numbers and percentages must be substantiated by attached tables and listings. In summary, the trial report should be an accurate representation of the clinical data. Allocation of trial... 

Industrial effluents result from various types of industrial processes and disposal practices, and may contain pollutants at levels that could affect the quality of receiving waters, as well as the aquatic ecosystem (Table 1). The emission of industrial pollutants in liquid effluents has to comply with stringent regulatory requirements and guidelines, in which chemicals listed should not exceed a given concentration. On the other hand, a chemical company may release a large number of different chemicals, which are not considered by regulatory requirements... 

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