Case study: The preapproval inspection - A program management template

被引：0
|
作者：
Noferi, JF
Arling, ER
Servin, E
机构：
[1] Pharmacia GS API Biopharma, QA Compliance & Validat, Global Supply, Skokie, IL 60077 USA
[2] Pharmacia, QA, Stragnas, Sweden
[3] Pharmacia GS API Biopharma, QA, Global Supply, Skokie, IL 60077 USA
来源：
BIOPHARM INTERNATIONAL-THE APPLIED TECHNOLOGIES OF BIOPHARMACEUTICAL DEVELOPMENT | 2003年 / 16卷 / 03期
关键词：
D O I：
暂无
中图分类号：
Q81 [生物工程学（生物技术）]; Q93 [微生物学];
学科分类号：
071005 ; 0836 ; 090102 ; 100705 ;
摘要：
Preparing for a preapproval inspection requires careful thought and planning. Here, the authors offer a model document to take you step-by-step through the process, from setting goals and assigning responsibility to deciding on the make-up of the various teams.
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页码：56 / +
页数：5
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