美国FDA分析方法证指南英文对照美国FDA分析方法证指南中英文对照.docVIP

美国FDA分析方法验证指南中英文对照（二） 上一篇 / 下一篇 ?2009-01-05 10:44:15 / 个人分类：GMP/GLP 查看( 1076 ) / 评论( 2 ) / 评分( 0 / 0 ) III. TYPES OF ANALYTICAL PROCEDURES A. Regulatory Analytical Procedure A regulatory analytical procedure is the analytical procedure used to evaluate a defined characteristic of the drug substance or drug product. The analytical procedures in the U.S. Pharmacopeia/National Formulary (USP/NF) are those legally recognized under section 501(b) of the Food, Drug, and Cosmetic Act (the Act) as the regulatory analytical procedures for compendial items. For purposes of determining compliance with