Regulatory and compliance

Traditionally, regulatory and compliance testing requires gravimetric determination of, for example, fuel mass emissions. Instruments utilizing collecting or in situ measurement techniques are used for the analysis of various particle parameters for nonregulatory purposes. 

During a Nevada field demonstration, approximately 333 yd of soil and debris contaminated with up to 1100 pCi/g of plutonium was processed at the U.S. Department of Defense s (DOD s) and doe s Tonapah Test Range. The actual cost of the demonstration was 138,126. This figure included 8203 for regulatory and compliance issues, 29,614 for mobilization, 78,545 for physical treatment, and 21,764 for demobilization (D21040S, p. 78 D21231X, p. 14). 

The goal of this chapter is to provide an understanding of the overall stability study process and its corresponding compliance challenges. It is hoped that such an understanding will result in stability studies that not only meet all regulatory and compliance requirements, but also improve and increase the assurance of the quality of the marketed product. 

However zero-time is defined, it is important to consistently honor that time point, as this has been a recurring compliance concern for the FDA. The notion that there is a grace period for a zero-time point or any other test-time point can have serious regulatory and compliance implications. 

Information for Clinical Investigators. This Web page includes guidances, information on Institutional Review Boards, and protection of human subjects in clinical trials, along with links to clinical regulatory and compliance resources. 

The following list contains relevant CMC guidances, draft and final, related to the regulatory and compliance documents required by the FDA for U.S. submissions and by the ICH for international dossiers. Although some of the listed guidances are in draft form, they represent FDA s current thinking and are useful references. 

MediRegs. URL http //www.mediregs.com (accessed October 2005). Provides regulatory and compliance databases to medical device, pharmaceutical, and food industries. For the device industry, provides two libraries of services MediRegs + FOI... 

A web-based approach to data access can be considered and issues such as access control, security, and levels of access must be addressed (24). Scalability and back-up capabilities are among the issues that may influence decisions at this level. Further guidance from the Society of Clinical Research Associates and published literature (25) can assist with system documentation, system and database security, maintenance of data integrity, regulatory, and compliance issues (23). 

Ben Rejeb S, Lauer B, Salminen J, et al. (2004). Regulatory and compliance activities to protect food allergic consumers in Canada research in support of standard setting and consumer protection. J. AOAC Int., 87(6) 1408-1416. 

Figure 2.2 outlines the types of regulatory and compliance strategies that are used in the process industries, along with examples of that particular approach. (In practice, aU regulations contain elements of both approaches— however, a sharp distinction between them is made here in order to... 

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