Manufacturing regulatory requirements

Specialized training is an absolute requirement for technical service personnel. A typical example is a person involved in supporting a polymer for which the use is the manufacture of rotationaHy molded consumer products. The technical service person is expected to be reasonably familiar with topics such as polymer rheology evaluations, gel-permeation chromatography, rotational mol ding, color science, regulatory requirements for use, mechanical and photochemical behavior of the pigmented polymer, optics, and so forth. Expertise of this variety caimot be expected to be obtained without careful... 

Drinking water suppHed to carbonated soft drink manufacturing faciUties from private or municipal sources must comply with all regulatory requirements. Treated water must meet all U.S. Environmental Protection Agency primary maximum contaminant levels and may also be subject to additional state requirements. Treated water is routinely analyzed for taste, odor, appearance, chlorine, alkalinity, iron, pH, total dissolved soHds, hardness, and microbiological contamination. 

The standard requires that all products or materials used in part manufacture satisfy current regulatory requirements applicable to the country of manufacture and sale. 

Additives and the blending process became an increasingly important part of gasoline manufacture after World War II. Refiners had to balance such factors as customer specifications, regulatory requirements, and probable storage (i.e., nonuse) time. The... 

Tables 2.6 and 2.7 give examples of the modes of action of pollutants in animals and in plants/fungi, respectively. It is noteworthy that many of the chemicals represented are pesticides. Pesticides are designed to be toxic to target species. On the other hand, manufacturers seek to minimize toxicity to humans, beneficial organisms and, more generally, nontarget species. Selective toxicity is an important issue. Regardful of the potential risks associated with the release of bioactive compounds into the environment, regulatory authorities usually require evidence of the mode of toxic action before pesticides can be marketed. Other industrial chemicals are not subject to such strict regulatory requirements, and their mode of action is frequently unknown.

The survey showed that all the countries have planned GMP inspections. These plans are generally based on regulatory requirements relating to frequency of inspection. For instance, in the Netherlands, manufacturing plants are inspected at least once every two years. For Venezuela, the plan is activity-based it is set in terms of the number of inspections to be conducted per month. But most dmg regulatory authorities determine statutory frequencies for GMP inspection by considering the number of manufacturing plants. 

Medical grade plastics are discussed with reference to biocompatibility and the tests that the end-product manufacturer should perform in order to ensure the safety of the material. Regulatory requirements are described, and tabulated data is presented on mostly European suppliers of medical grade plastics. The data shows that most companies rely onUSP Class VI certificates to demonstrate the suitability of their materials for the medical industry. However, it is argued that most manufacturers of medical devices would benefit more from tests carried out according to ISO 10993. 6 refs. 

As you can see, during the regulatory development of TSCA, the chemical industry has been alert to the practical impacts of the law and its ensuing regulations. Representatives of individual manufacturers, CMA and other trade associations, have participated at every opportunity to provide EPA with the factual data it requires and to show the practical implications of its proposals in order to prevent EPA from over-extending its power beyond its statutory authority. CMA has asked EPA to be more sensitive to the impact of these regulatory requirements on innovation and other economic aspects of this i ndus try. 

Should there be a minimum regulatory requirement for reactive hazard identification and evaluation that apples to all facilities engaged in chemical manufacturing ... 

The US Food and Drug Administration (FDA) is required by the US Federal Food, Drug, and Cosmetic Act to regulate drug products in the United States. Its role is to ensure that drugs are developed, manufactured, and marketed in accordance with regulatory requirements so that they are safe and effective. The FDA has four centers and a regulatory office ... 

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