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ＧＭＰ中的Ｖａｌｉｄａｔｉｏｎ日本制药工业协会川村邦夫随着药事法修改（１９９３）和ＷＨＯＧＭＰ修订版的公布（１９９２），日本也要修订自己的ＧＭＰ。经修改的ＧＭＰ不仅将药１品生产场所的建筑布局和设备，而且还将＂药品生产及质量管理＂即所谓＂ＧＭＰ软件＂列...
GMP Validation Japan Pharmaceutical Industry Association Kawamura Bonof With the revision of the Pharmaceutical Law (1993) and the publication of the revised WHOGMP (1992), Japan also revised its GMP. The modified GMP will not only the building layout and equipment for the pharmaceutical production sites, but also the so-called “GMP software” column of “Drug Production and Quality Management”.