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美国联邦法案210、211部分内容变更
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美国联邦法案210、211部分内容变更，2008年12月8日开始实施，摘要如下，具体内容见附件（英文）： The Food and Drug Administration (FDA) is amending certain of its regulations on current good manufacturing practice (CGMP) requirements for finished pharmaceuticals as the culmination of the first phase of an incremental approach to modifying the CGMP regulations for these products. This rule revises CGMP requirements primarily concerning aseptic processing, verification of performance of operations by a second individual, and the use of asbestos filters. We are amending the regulations to modernize or clarify some of the requirements as well as to harmonize them with other FDA regulations and international CGMP standards. [search]美国210、211[/search] |
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