…GMP is a set of standards for facilities, equipment, and the education and organization of those involved in the manufacture of pharmaceuticals, and requires strict management of the manufacturing process, product quality, hygiene, and safety. Following GMP, GLP (Good Laboratory Practice, a standard for non-clinical safety testing) was implemented in the United States in 1979, and in Japan, the Ministry of Health, Labor and Welfare established it and has been in effect since 1982. … *Some of the terms that refer to "Good Laboratory Practice" are listed below. Source | Heibonsha World Encyclopedia 2nd Edition | Information |
…GMPとは,医薬品の製造に関し,施設,設備,製造に従事する人の教育と組織についての基準を定めたもので,製造工程や製品の品質,衛生や安全性への厳しい管理が義務づけられている。さらに,GMPに続いて,GLP(Good Laboratory Practiceの略。〈非臨床の安全性試験に関する基準〉)が,79年アメリカで実施され,日本でも厚生省がこれを定め,82年から実施されている。… ※「Good Laboratory Practice」について言及している用語解説の一部を掲載しています。 出典|株式会社平凡社世界大百科事典 第2版について | 情報 |
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