Polymers used for Pharmaceutical Packaging and Medical Devices Quality and supply assurance

被引:0
作者
Reckzuegel, Gaby [1 ]
机构
[1] Boehringer Ingelheim Pharma GmbH & Co KG, D-55216 Ingelheim, Germany
来源
PHARMAZEUTISCHE INDUSTRIE | 2009年 / 71卷 / 12期
关键词
Pharmaceutical packaging; extractables; material changes; regulations; supply assurance; Polymers;
D O I
暂无
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
The following paper provides an overview on the regulatory, technical, and strategic requirements for polymers used for pharmaceutical packaging and medical devices and presents the definition and impact of material changes. Some of the working groups of pharmaceutical companies working on a common understanding of the pharmaceutical industry and their suppliers on these needs and requirements are introduced.
引用
收藏
页码:2109 / 2112
页数:4
相关论文
共 9 条
  • [1] [Anonymous], JAPANESE PHARMACOPOE
  • [2] [Anonymous], RECOMMENDATIONS FEDE
  • [3] *COUN EUR DIR QUAL, EUR PHARM
  • [4] *CPMP, 41001 EMEA CPMP CVMP
  • [5] *CPMP QWP, 2005, CPMPQWP435903
  • [6] *DIN EN, 224422007 DIN EN
  • [7] *DIN EN ISO, 109932003 DIN EN ISO
  • [8] US Food and Drug Administration, 1999, Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics
  • [9] *US PHARM CONV, US PHARM NAT FOR USP