Safety considerations documentation

To confirm that product safety considerations have been addressed, review of tunnel construction and operation materials for product contact potential or suitability shall be documented. Tunnel construction materials, which contact the sterilization medium, shall be identified. This would include ... 

As noted above, all available information on the historical use of botanical preparations will be accepted for safety consideration. But for FDA clinical reviewers, such experiences are often poorly documented and difficult to interpret or correlate with the paradigm of conventional (Western) medicine. In the alternative medical system, almost all the diagnoses to be treated with herbal medicine are defined in imprecise and foreign terms. Typically, one herbal medicine is indicated for numerous seemingly unrelated conditions, most of which are symptomatic relief without clear mechanisms. Furthermore, many botanicals are combinations of multiple herbs, but few references are available for the rationale of combining so many ingredients. 

Process Safety Information. Employers must compile considerable documented process safety information on the hazards of chemicals used in a covered process as well as information on the process technology and equipment before conducting the process hazard analyses required by the standard. 

Various institutions and local, state, and federal agencies may require certain considerations, documentation, or training for some laboratory operations, particularly (but not restricted to) those involving especially hazardous materials, equipment, or procedures. The laboratory worker and supervisor are responsible for understanding and ensuring compliance with such mandates, but they need to be aware that not all hazards are regulated and not all regulations are sufficient and that other safety measures may be necessary. 

Safety Considerations are the documented results of a process to identify, as soon as possible after a mature Operational Concept has been developed, the main safety issues associated with a Project and to help in deciding whether a full Safety Plan and Safety Case are required. 

The inspection team shall refrain from any action during the course of an inspection which by its nature could endanger the safety of the team, the facUity, its persoimel, or cause harm to the environment. The inspected State Party may decline to conduct certain inspection activities, requested to be performed by the inspection team, if the inspected State Party considers that such activities could endanger the safety of the facUity, its persoimel, or the inspection team In such cases, the inspected State Party shall explain the circumstances and safety considerations involved, and provide alternative means for accomphshing the inspection activities. The inspection team shall record any refusal of inspection activity, as well as inspection team comments and the inspected State Party s explanation, in the document on preliminary findings and in the final inspection report. 

OSHA considers representatives of the oven manufacturer to be qualified persons who are knowledgeable of the various safety considerations and of the safe operational characteristics of the equipment. They may or may not be employees for the oven manufacturer. Refer to the April 24,1998, letter to the American Bakers Cooperative, Inc. that is posted on the OSHA public webpage for details http //www.osha.gov/pls/oshaweb/ owadisp.show document p table=INTERPRETATIONS p id=22573... 

In the context of environmental risk/safety, several guidance documents have been developed that focus on an approach to evaluating environmental risk/safety, such as the Safety Considerations for Biotechnology Scale-up of Crop Plants published by the OECD (1993). In addition, many other OECD documents, developed through consensus of the member countries, have provided the basis for... 

Plant must be properly designed, installed, commissioned, operated and maintained. Depending upon the risk, working procedures should be documented, e.g. as codes of practice. Consideration of safety at the design stage was discussed in Chapter 12. 

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