Safety regulatory controls

The FDA of the U.S. Department of Health and Human Services (DHHS) administers the regulatory controls for the Food, Drug, and Cosmetic Act of 1906 and the 1976 and 1990 amendments, which provide approval for commercial distribution of safe and effective medical devices. The 1976 amendments directed the FDA to regulate medical devices under control levels that are necessary to ensure safety and effectiveness. In order to achieve this task, the Medical Device Law under the amendments required the FDA to issue regulations placing all medical devices on the market at that time into one of three regulatory classes ... 

Koh H, Woo S. (2000) Chinese proprietary medicine in Singapore Regulatory control of toxic heavy metals and nndeclared drugs. Drug Safety 23 351-362. 

Calixto JB. Efficacy, safety, quality control, marketing and regulatory guidelines for herbal medicines (phytother-apeutic agents). Braz J Med Biol Res 2000 33 179-89. 

IAEA (1988). International Atomic Energy Agency. Principles for the Exemption of Radiation Sources and Practices from Regulatory Control, Safety Series No. 89 (International Atomic Energy Agency, Vienna). 

Economic Incentives for Automation Projects Industrial applications of advanced process control strategies such as MPC are motivated by the need for improvements regarding safety, product quality, environmental standards, and economic operation of the process. One view of the economics incentives for advanced automation techniques is illustrated in Fig. 8-41. Distributed control systems (DCS) are widely used for data acquisition and conventional singleloop (PID) control. The addition of advanced regulatory control systems such as selective controls, gain scheduling, and time-delay compensation can provide benefits for a modest incremental cost. But... 

Regulatory Control of Food Composition, Quality, and Safety... 

Most of these valves will be used to achieve basic regulatory control of the process (1) set production rate, (2) maintain gas and liquid inventories, (3) control product qualities, and (4) avoid safety and environmental constraints. Any valves that remain after these vital tasks have been accomplished can be utilized to enhance steady-state economic objectives or dynamic controllability (e.g., minimize energy consumption, maximize yield, or reject disturbances). 

Electronic records requiring particular regulatory control should be identified based on critical process control points and associated critical parameters that directly impact product quality or product safety. A defined process should be used to conduct this analysis, and it should be one that builds on or is complementary to any assessment conducted as part of product registration. Consistency is key. There may be additional records identified by predicate rules but care must be taken not to extend beyond these records. A risk assessment should be conducted to determine appropriate electroific record management controls such as audit trail and archiving. Electronic records will need to be archived for retention periods specified in predicate rules. Other data related to process performance rather than product quality or product safety requires only basic data maintenance and may be retained for much shorter periods before being purged. 

The term soap thus has two meanings. The first is the FDA s definition, which is used for legal purposes. The second is the generic sense, whereby soaps may refer to cleansing products that may not meet the specifics of FDA s definition. Such products must, therefore, be labeled as cosmetics. The Federal Trade Commission (FTC) and the Consumer Products Safety Commission (CPSC) handle the regulatory control for soaps. 

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