Historical and hygienic aspects on roles of quality requirements for antibiotic products in Japan: Part 4 - Enactment of requirements for individual antibiotic products.

Abstract

Supplies of high quality antibiotic products to clinics contributed greatly to the health maintenance of the citizens of Japan. In this report, we describe the results of our investigation and analyses on the establishment and amendments of 'he quality standards for individual antibiotic products, which were regarded as the guidelines for quality control in the production processes. "The minimum requirements of penicillin" enacted in May of 1947 was at a relatively moderate standard level, due to considerations for domestic technical levels. However, after several amendments, in response to the rapid development of manufacturing technologies and new penicillin preparations, standards became increasingly stricter. "The minimum requirements of streptomycin" enacted in December of 1949 was prepared by the use of streptomycin preparations imported from the USA. The 3rd and 4th standards, "the minimum requirements of dihydrostreptomycin" and "the minimum requirements of chloramphenicol", were prepared by applying provisions described in the rules for certification of the U.S. Food and Drug Administration. In accordance with an increase in the varieties of antibiotic products, "the minimum requirements of antibacterial products" was enacted by the integration of previously existing standards and newly enacted ones. Thereafter, in response to the innovation of scientific technologies and the globalization of antibiotic products, "the minimum requirements for antibiotic products in Japan" was further developed and became the basis for supplying high quality antibiotic preparations.