Guidelines and regulations

Salgot M, Pascual A (1996) Existing guidelines and regulations in Spain on wastewater reclamation and reuse. Wat Sci Tech 34(ll) 261-267... 

However, tempting it is for the pharmaceutical physician, the investigators and the sponsors to use advertising, they should be aware that there are certain guidelines and regulations to observe before embarking on any advertisement for a clinical trial. 

There exist guidelines and regulations, described elsewhere in this book, to control ... 

EPA (1978). U.S. Environmental Protection Agency. Hazardous waste guidelines and regulations, Proposed rules, 43 FR 58946 (U.S. Government Printing Office, Washington). 

Sediments can be relocated within water bodies only if they meet certain quality requirements. In Europe, this is known as the eco-political objective. However, a generally accepted concept to adequately define sediment quality criteria is still lacking, because effects-based scientific knowledge still needs to grow to ameliorate management guidelines and regulations. 

CIA in DBA/1 Mice 1. Male DBA/1 mice (Harlan [see Note 1]), 8-12 weeks old. All animal experiments have to be done in accordance with institutional and national guidelines and regulations. 

ICPEMC prepares documents that evaluate current knowledge and that can serve as a basis for guidelines and regulations... 

Within the past decade, international guidelines and regulations have become more uniform through... 

The primary considerations which need to be addressed during or after the process development cycle with respect to environmental issues are (1) disposal of spent packing, (2) solvent disposal, (3) solvent recovery. (4) obtaining the air permits for the solvent systems in use, (5) systems in place to meet OSHA and EPA guidelines, and (6) the DOT classification. Environment guidelines and regulations are not within the scope of this chapter. 

The USP is not the only body setting standards for drug packaging. In addition to the information contained in the USP, the Food and Drug Administration (FDA) and the Consumer Product Safety Commission (CPSC) set packaging guidelines and regulations. 

Bohaychuk W, Ball G. 1994. Good Clinical Research Practices. An Indexed Reference to International Guidelines and Regulations, with Practical Interpretation (available from authors). 

Inspection readiness is another area where the QA function can contribute considerably to establish systems and procedures which ensure that a company is always ready for an inspection. This includes a dependable SOP system in full compliance with guidelines and regulations, up-to-date training programs and documented training for all employees with complete training files, current CVs for all persons involved in clinical research, current organizational charts and job descriptions, contracts in place with all external providers and so on. QA auditors can help establish and maintain a state of inspection readiness in the company. 

Conduct and coordinate research drug investigations and research under FDA guidelines and regulations and approval by appropriate local officials... 

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