Definitions Regulations

Applicability of current good manufacturing practice regulations. Definitions. 

National Primary Drinking Water Regulations Definitions Yes 40 CFR 141.2 EPA 1975... 

Drugs are chemical entities, precisely measurable and controllable within close tolerances. Tolerances can be established on the product, and within these tolerances one can live with the drug. If the dmg is out of specification, it is beyond these tolerable limits. It is very different for biologics. The [Code of Federal Regulations] definition is that a biologic involves the product, the manufacturing activity, the product facility, and the people. Inherent natural variability exists at every stage of the process, at every element of the system. Some variability is controllable some is never controllable. 

This document acknowledges that nomenclature develops - without regulated definition - as the field of thermal analysis develops. Some terms used by authors and scientists rapidly become accepted by the scientific community, even if the term is not consistent with past definitions, science or grammatically correct. However, if such a term is widely used and understood, it is reported here. 

According to the U.S. Code of Federal Regulations, food additives may be defined as "substances. .. the intended use of which results or may reasonably be expected to result, directly or indirectly, either in their becoming a component of food or otherwise affecting the characteristics of food" (1). Canada and the European Community have adopted similar definitions. According to this broad definition, a food additive is synonymous to a food ingredient. In practice, however, the word additive is limited to substances that are used in small quantities. 

Definitions. Cosmetic products in the United States are regulated by FDA under the authority of two different laws, ie, the Federal Food,... 

The proper selection of chemical shipping descriptions, and the deterrnination of the ha2ard class, requite chemical expertise and familiarity with DOT definitions of such classes, which are provided in Part 173 of the ha2ardous materials regulations. In some cases such definitions are sufficientiy... 

Thermal treatment is used to destroy, break down, or aid in the desorption of contaminants in gases, vapors, Hquids, sludges, and soHds. There are a variety of thermal processes that destroy contaminants, most of which are classified as incineration. Incineration HteraHy means to become ash (from Medieval Latin, incinerare in or into ashes). With respect to the incineration of hazardous wastes regulated in the United States, however, there is a strict legal definition of what constitutes an incinerator. The Resource Conservation and Recovery Act (RCRA) definition of incinerator at 40 CFR 260.10 is... 

Hazardous Wastes The U.S. EPA has defined hazardous waste in RCRA regulations, CFR Parts 260 and 261. A waste may be hazardous if it exhibits one or more of the following characteristics (1) ignitability, (2) corrosivity, (3) reactivity, and (4) toxicity. A detailed definition of these terms was first published in the Federal Register on May 19, 1980, pages 33, 121-122. A waste may be hazardous if listed in Appendix Wll. 

The Berlin City electrical engineer M. Kallmann reported in 1899 on a system for controlling stray currents of electric railways [64]. As early as 1894, the Board of Trade in London issued a safety regulation for the British electric railways which specified a potential differential of not more than 1.5 V where the pipeline was positive to the rails, but 4.5 V with the rails positive. Extensive research was undertaken on reducing the risk of stray current in the soil by metallic connections from pipes to rails. However, as one writer noted, a procedure on these lines should definitely be discouraged as it carries the seed of its own destruction [64]. 

Once an adequate definition of the product is made, the design of the seal environment can be selected. There are four general parameters that an environmental system may regulate or change ... 

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