Regional organizations, development standards

The net result of such regulation is that there are well-developed standards for the way in which quantitative and, increasingly, qualitative measurements are carried out. There are also well-defined limits for various categories of impurity, all of which tends to emphasise the importance of measurements on the final API rather than on the process that produces it, for which the requirement is simply that the process remains under control . The importance of this summary is that at present, whatever the means of production, there is a requirement that the API will reach certain standards of purity as demonstrated by end-point measurement. Those standards effectively demand quantification of impurities down to about 0.05% for related organic impurities, in the region of ppb to low ppm for known toxins and low ppm levels for inorganics such as catal3Tic metals. 

Parallel to these regional or national initiatives, efforts were also made on a global level in order to develop truly international norms for biodegradable materials. A working group was created within the International Organization for Standardization (ISO) to deal with biodegradable plastics and various test methods, which have subsequently been adopted as ISO standards. 

Although much work needs to be done in developing organic regulatory structures at an international level that are truly sensitive to the needs of producers and the local realities that they face, a harmonised standards architecture based on general baseline standards upon which local or regional standards can be fleshed out, along with an allowance for justified variations, offer useful models and tools that can be built upon. 

A number of organizations have contributed to the above developments and programs are being established at the national, regional, and international levels, to help provide the standards needed to facilitate traceability [1-9]. An important aspect of this work is the demonstration of the equivalence of the various standards used in different parts of the world. 

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