PDA TR25_混合均匀性要求 _Blend Uniformity_1997.pdfVIP

Blend Uniformity Analysis: Validation and In-Process Testing 混合均匀性分析：验证和加工过程中测试 Technical Report No.25 PDA Document PDA Technical Report, Blend Uniformity Analysis: Validation and In-Process : Testing Authors: Jonathan Berman, Ph.D.,Abbott Laboratories Don E. Elinski,Geneva Pharmaceuticals, Inc.Celedon R. Gonzales, Eli Lilly and Company Jeffrey D. Hofer, Eli Lilly and Company Pedro J.Jimenez, Ph.D., Eli Lilly and Company JeromeA. Planchard, Ph.D., Hoechst Marion Roussel, Inc. RandallJ.Tlachac, MGI Pharma, Inc. Paul F. Vogel, Lachman Consultant Services This technical report represents theviews of the authors and PDAs Solid Dosage Process Validation Committee； it does not necessarily represent theviews of the companies employing the authors. 本技术报告代表作者和PDA固体制剂工艺验证委员会的观点；并不一 定代表雇用这些作者的公司的观点。 ABSTRACT 摘要 One of the most challenging problems confronting oralsolid dosageform manufacturers today is the difficulty inapplying scientifically valid methods to blend uniformity validation. TheWolindecision in U.S.v. Barr Laboratories causedthe FDA to reexamine and modify its policies on blend uniformity and sampling techniques.The resulting policies are predicated onthe assumptionthat current technology provides a means to consistently collect minute representative samplesfrom much largerstatic powder blends.A comprehensive review of the scientific literature indicates that current sampling technology is plagued by a propensity forsampling bias.This limitation is particularly troublesome to the pharmaceutical industry which must then hold these samples tovery highstandards. In response to these concerns the PDA Solid Dosage ProcessValidation Committee has reviewed approaches to blend uniformity analysis. 目前口服固体制剂生产商面临的最有挑战性的问题之一就是在混和均一性验证中使用科学地 验证方法的难度。U.S.v.Barr 实验室的Wolin决定使FDA重新检查和修订了关于混和均一性和 抽样技术的方针。所得出的方针的依据是：现有技术提供了一个从巨大量的静