Japanese Standardization Agency

Fig. 1 Exemplified overview and interconnectivity of standardization of analytical methods for food. CEN The European Committee for Standardization, ISO International Organization for Standardization, JSA Japanese Standardization Agency, AACC American Association of Cereal Chemists, AOAC Association of Official Analytical Chemists, CCMAS Codex Committee of Methods of Analysis and Sampling...

A more careful comparison has also been made. JAXA (the Japanese Space Agency) and MIT engineers compared the use of STPA on a JAXA unmanned spacecraft (HTV) to transfer cargo to the International Space Station (ISS). Because human life is potentially involved (one hazard is collision with the International Space Station), rigorous NASA hazard analysis standards using fault trees and other analyses had been employed and reviewed by NASA. In an STPA analysis of the HTV used in an evaluation of the new technique for potential use at JAXA, all of the hazard causal factors identified by the fault tree analysis were identified also by STPA [88]. As with the BMDS comparison, additional causal factors were identified by STPA alone. These additional causal factors again involved those related to more sophisticated types of errors beyond simple component failures and those related to software and human errors. 

Japan JISC,JIS, Japanese Industrial Standards Committee, Agency of Industrial Science and Technology, Ministry of International Trade and Industry, 1-3-1 Kusumigaseki Chiyoda-Ku, Tokyo 100. 

Water for injection (WFI) is the most widely used solvent for parenteral preparations. The USP requirements for WFI and purified water have been recently updated to replace the traditional wet and colorimetric analytical methods with the more modern and cost-effective methods of conductivity and total organic carbon. Water for injection must be prepared and stored in a manner to ensure purity and freedom from pyrogens. The most common means of obtaining WFI is by the distillation of deionized water. This is the only method of preparation permitted by the European Pharmacopoeia (EP). In contrast, the USP and the Japanese Pharmacopeias also permit reverse osmosis to be used. The USP has also recently broadened its definition of source water to include not only the U.S. Environmental Protection Agency National Primary Drinking Water Standards, but also comparable regulations of the European Union or Japan. 

Presented together by the British, European, Japanese, and U S. Pharmacopeias, the first Interpharmacopeial Open Conference on Standards for Excipients was convened in Orlando, FL, from January 30-February 1, 1991 (Table 1). Attended by 165 participants, representation included 11 countries, 59 pharmaceutical or excipient manufacturers or suppliers, three regulatory agencies (FDA, EEC, and HPB), and seven pharmacopeias (the presenters and the French, Italian, and Spanish Pharmacopeias) [17]. In preparation for this conference, USP convened open meetings on Magnesium Stearate and Lactose attended by almost every major manufacturer from Europe and the United States. 

From 4th Revision of Table of Japanese Food Standard Ingredients, Resources Council, Science and Technology Agency, Japan. 

There is a Japanese pharmacopeia that sets official standards and diverse government agencies that perform tasks undertaken by an FDA. It is rumored that... 

Publication Board (PB) Reports. This collection originally contained captured German and Japanese scientific reports and German patents which were acquired between 1946 and 1949. The collection now includes unclassified technical reports of the Army, Navy, Air Force, and their contractors. National Bureau of Standards, Maritime Administration, Federal Aviation Agency, Bureau of Mines, Department of Health, Education, and Welfare, and the National Aeronautics and Space Administration. 

To analyze in accordance with procedures provided in the Japanese Industrial Standard or those established by the Environment Agency and MHW of Japan, in order to evaluate outgoing streams on the basis of Japanese national environmental standards and emission and effluent standards,... 

The features of a particular biopharmaceutical are the result of the basic characteristics of the molecule such as amino acid sequence and three-dimensional structure as well as the specihc production, purihcation, formulation, and storage conditions (Box 12.4-2). To produce a biopharmaceutical of constant required quality, a company also needs the experience and the in-house standards to apply the methods used to analyze the structure of a given product. There are various guidelines of the European Medicine Evaluation Agency, the Food and Drug Administration, the Japanese Ministry of Health and Welfare, and the ICH, which require manufacturers to show that they control the production process and are capable of reproducibly manufacturing batches that not only meet product specih-cations, but also conform to the dehnition of the product as established through full characterization. Modihcations of the established process are only accepted if the manufacturer can show that the product of the new process is comparable with the initially manufactured product. Comparability studies include revalidation of... 

Japanese Industrial Standards Committee c/o Standards Department Agency of Industrial Science and Technology... 

Key CL, chemiluminescence UV, ultraviolet IR, infrared FTIR, Fourier-transform infrared spectroscopy TOLAS, tunable diode laser absorption spectroscopy IDS, indigo-5,5 -disulfon-ate ASTM, American Society for Testing and Materials ERA, US Environmental Protection Agency approved methods JIS, Japanese Industrial Standard WHO, World Health Organization selected methods n.a., not available. 

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