Safety and quality assessment

SQAS SAFETY AND QUALITY ASSESSMENT SYSTEMS FOR THE TRANSPORT/STORAGE/HANDUNG OF CHEMICALS... 

In the early 1990s, chemical companies recognized the need to take a fresh look at the safety, quality, and environmental aspects related to the provision of logistics services. Within the framework of the Responsible Care Programme, initiatives were started that have since evolved into a number of safety and quality assessment systems (SQAS), each related to a particular transport mode or logistics operation. 

Safety and quality assessment systems enable chemical companies to have the quality and safety management systems of their logistics service providers assessed in a uniform manner, thereby avoiding multiple assessments by individual chemical companies. The results of an SQAS assessment carried out by an independent body do not lead to a certificate but are used by an individual chemical company to evaluate the performance of service providers... 

Safety and quality assessment systems are the prevention part of the European Chemical Industry Council s International Chemical Environment (ICE) initiative, complementing the ICE Emergency Response Programme in the field of chemical transport safety. 

The purpose of registration is to assess drugs for efficacy, safety and quality and to ensure that they are of an acceptable standard for use. When similar products are processed, the rates of registration approval and rejection reflect the ability of the registration system to prevent questionable products from gaining market access (3). 

Transcriptomic, proteomic, and/or metabolomic approaches have already been shown to be extremely useful to assess food safety and quality at every stage of production to ensure food safety for human consumption. They are also valuable tools to distinguish between similar food products and to detect food frauds (adulteration, origin, authenticity, etc.), food-borne pathogens, toxic species, food allergens, etc. 

The use of medicinal products and therapies in man is more driven by ethical and much less by economic considerations. Direct commercial aspects such as cost of the product may be less critical. Instead, the assessment should concentrate more on safety and quality aspects and their scientific and economic ramifications. 

To assess the efficacy, safety and quality of new drugs to meet unmet clinical needs. 

Both human and animal health products need to be safe, efficacious, and of defined quality. For major markets in the world, both animal and human products need to be manufactured in GMP facilities. For human products, regulatory requirements are set for the areas of toxicity, safety, dosing intervals, therapeutic effect, stability, manufacturing, etc. Veterinary products not only include all of the above but are also required to address tissue residue, handler safety, and environmental assessment, particularly if the product is for food-producing animals. If producing a new antimicrobial agent for food-producing animals, the issue of antimicrobial resistance also needs to be addressed. Details about these special requirements were covered in section Residue of this chapter. 

The assessment of eaeh Critieal Control Point will reveal the adequacy of current procedures for production management and control, and the range of current problems and opportunities with regard to improving the safety and quality of eaeh commodity group. 

Some systems, such as the UnitedStates Veterans Affairs, have invested heavily in both financial and quality assessments and as a consequence can monitor and track quality over time. In many healthcare systems, a considerable amount of safety and quality data is collected, but this has relatively little impact on day-to-day practice. The problem in Britain at least is not the paucity of the data but that the available information is widely scattered and not easily accessible to clinical teams and managers. The Bristol Inquiry report for instance, concluded that Bristol was awash with data (Aylin et al, 2004). However, little of this information was available to parents and it did not help in the identification, prior to the Enquiry, of the problems brewing there. A central feature of the recent report by Darzi (2009) is that quality must be the defining principle of the British NHS and that quality needs to be systematically measured. 

Assessing the impact of safety and quality interventions is difficult, partly because hospitals are complex, but also because the intervention itself may be complex, ranging over many different clinical areas and across different levels of the organization front line staff, middle management and the executives are all involved. In a randomized trial, one endeavours to specify the treatment as... 

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