Scrutiny regulatory

Under the new administration, this section of TSCA has come under the scrutiny of Vice President Bush s task force on regulatory relief and the Office of Toxic Substances is placing a high priority on efforts to develop more cost-effective means for achieving industry compliance with OTS policies. In addition to fostering voluntary actions by industry wherever possible in lieu of formal rules, these effects include elimination of unnecessary burdens on industry in complying with mandated TSCA requirements. 

The weakness in the current regulation has to do with its ambiguity. The line between a beneficial claim and a curative claim is sometimes difficult to draw. What is the difference, for example, between an agent that enhances memory and one that prevents memory loss Given the number of products and claims hitting the shelves every day, this situation will probably demand increased regulatory scrutiny in the future. 

FDA has recently indicated that FDA s traditional model of manufacturing site inspections and border examinations is simply not adequate in today s transformed world (Mullin, 2011). There is a general understanding that when companies outsource a function(s) to a CRO/CMO that these organisations in turn, become subject to the same regulatory responsibilities and scrutiny as their clients, i.e. control of the product s quality has to be maintained (Linna et al., 2008). 

Bach J-F Regulatory T cells under scrutiny. Nat Rev Immunol 2003 3 189-198. 

Process analytics have already been utilized in process development, realizing all the benefits of the methodology in the R D environment without facing particnlar regulatory scrutiny as often assumed for commercial manufacturing applications. With the increased use of concepts like design of experiments. 

The introduction of GCP has accelerated the need for quality control and quality assurance, particularly in the field of clinical research. Quality control is carried out by the staff who are responsible for the particular activity, working to SOPs that cover all the tasks under scrutiny. SOPs not only need to be written but must also be updated regularly. Quality assurance is the process which seeks to confirm that SOPs have been observed this is accomplished by the process of auditing. Internal audit departments should be under a separate management from the medical department. Regular audits can not only assure external bodies, such as regulatory authorities, that proper procedures have been followed, but also serve to deter those rare attempts at fraud on the part of clinical investigators, which occasionally become evident. ... 

Risk-based orientation Regulatory scrutiny based on the level of scientific understanding Mechanistic basis for understanding failure modes and variability Sources of variability and risk to quality Drive out fear Continuous improvement— Change control and life cycle management... 

Risk based regulatory scrutiny that relates to the level of scientific understanding of how formulation and manufacturing process factors affect product quality and performance and the capability of process control strategies to prevent or mitigate risk of producing a poor quality product. 

The absence of judicial review and of independent, external scrutiny of regulatory agencies, combined with the small size and relative political impotence of Sweden s chemical industry and the strong anti-industry sentimentin important parts ofthe public sector, have produced overzealous regulation of chemicals. This state of affairs is almost perfectly demonstrated in the following example. 

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