Both the International Organization for Standardization (ISO) and Good Manufacturing Practices (GMP) are examples of rules standardisation. The aim of standardising business and industrial rules is to achieve a higher level of consistency in such elements as raw materials, environmental friendliness, safety and final consumer product. Although these sorts of standards had their beginnings at the national and regional levels, in recent decades the increasing importance of the global economy has prompted their becoming more international.
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ISO was created after a meeting of 25 countries in 1946. A union of two antecedent organisations, the International Federation of the National Standardizing Associations (ISA) and the United Nations Standards Coordinating Committee (UNSCC), its mandate was "to facilitate the international coordination and unification of industrial standards." Since its start of business in Geneva, Switzerland in February 1947, ISO has produced 18,000 international standards for a wide range of industrial activities, and its membership has grown to 159 countries.
It is a voluntary, nongovernmental organisation without legal authority to require the acceptance of its standards. However, ISO standards have been used as the basis for legislation by the governments of some participating countries. In addition, some standards have become market requirements, such as ISO 9001 quality management systems and the dimensions of freight containers.
The disastrous side-effects of a sleeping pill, thalidomide, which caused over 10,000 infant deformities in the early 1960s, prompted the creation of GMP by the U.S. Congress in 1965. Its purpose was to regulate the U.S. pharmaceutical industry. GMP regulations are intended to require that those engaged in the business of drugs, medical devices, food and blood ensure that their products are safe, pure and effective.
Although it began at the national level, the concept of GMP for the pharmaceutical industry has been adopted by other countries, and the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was formed in 1990 to bring the regulations of the United States, Europe and Japan into harmony. ICH currently has 14 member states.
There are three principal differences between ISO and GMP: ISO is an international standard, and although the term GMP is used internationally, it is not technically an international standard. ISO standards are intended for industry in general, and GMP standards are only for the pharmaceutical, food and blood industries. GMP regulations have the force of law in the United States, and ISO standards are strictly voluntary. In spite of these differences, in the decades since their inception, ISO and GMP have each had a positive effect on the quality of life for people all over the world.
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