Regulating agencies

HVP products prepared by hydrolysis with HCl contain varying amounts of glycerol chlorohydrins, such as 3-chloro-l,2-propanediol [96-24-2] and l,3-dichloro-2-propanol [96-23-1J, depending on reaction conditions and Hpid contents of the starting material (135). As a result of their toxicides, regulating agencies in many countnes have restncted the contents of these compounds in food. 

Tanks Tank cars (single and multiple tank), tank trucks, portable tanks, drums, barrels, camoys, and cans are used to transport fluids (see Figs. 10-184-10-186). Interstate transportation is regulated by the DOT. There are other regulating agencies—state, local, and pri-... 

Select the desirable core style that will meet the needs of the application and of any regulator agency the power supply should meet (Appendix D). 

Some organizations develop risk assessment systems that first determine the regulatory impact of each computer system by using the following questions. If there is no regulatory impact, no validation activities are required by the regulating agencies. However, those systems can be validated for business or other reasons. 

The RCRA manifest requirements (40 CFR Parts 262 and 263) must be complied with for all wastes that are shipped off site. The regulations for transportation of hazardous wastes by the U.S. Department of Transportation, U.S. EPA, and states and local regulation agencies, should be complied with. A knowledge of RCRA regulations (40 CFR Parts 261-265) and other regulations developed by State Governments is required to determine the feasibility of off-site disposal. 

Good laboratory practice (GLP) is a set of procedures within which the overall performance of a laboratory can be monitored. It is applicable to the organization and functioning of any laboratory but it is particularly relevant to the pharmaceutical industry. Compliance with GLP may be required for accreditation of a laboratory by an external regulating agency. 

Governmental drug-regulating agencies have responsibility for monitoring drug safety. In the USA, the FDA-sponsored... 

Microfiltration is used widely in the pharmaceutical industry to produce injectable drug solutions. Regulating agencies require rigid adherence to standard preparation procedures to ensure a consistent, safe, sterile product. Microfiltration removes particles but, more importantly, all viable bacteria, so a 0.22- xm-rated filter is usually used. Because the cost of validating membrane suppliers is substantial, users usually develop long-term relationships with individual suppliers. 

RIN 0905-AB55 Orphan-Drug Regulations Agency Food and Drug Administration, HHS Action Final Rule... 

Critical Consequence—Class 1. Safety Critical instruments whose failure would either cause, or fail to inform of, situations resulting in accidental fire, explosion, uncontrolled release of dangerous materials, reportable environmental releases, or major property or production losses. The safety critical instruments assigned a Class 1 include those that have been mandated as such by regulating agencies an in-house technical safety review committee reliability studies and specific shutdown systems and specific alarms deemed critical by operations supervisors. 

In the United States and Japan, as well as other industrialized countries, the regulating agencies have established stringent air and water pollution standards. Perfecting new technologies that will meet these pollution requirements is a real challenge to the process developer. 

Chapter 2 reviews the pertinent government regulations issued by the regulating agencies (such as U.S. EPA, OSHA, and the Department of Agriculture) and how these regulations impact various industries and their personnel. 

In contrast, the premarket extension period is not automatically determined by either the PTO or the regulating agency (e.g., FDA). The patent holder must apply to the PTO for such a premarket extension (along with the specific time period requested) within a specific time period (60 days) after regulatory approval. 37... 

Since the linear model consistently predicts the highest response frequency per unit dose in very low dose range, it is usually the most conservative or least likely to underestimate human health risk. It is often recommended by regulating agencies to determine the risk of known or suspected human carcinogens. For non-carcinogens, the quadratic model that predicts a threshold dose at which there is no effect is often used. 

Well aware of this fact and stimulated by the new policy statements issued by the regulating agencies [1-3], the pharmaceutical industry has, over the past decade or so, systematically begun to develop chiral drugs in enantiomerically enriched and possibly pure form. Currently [3], 68% of the 1200 drugs under development world-wide are chiral, and 75% of these (or an amazing 51% of the total number) are developed as single isomers. ... 

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