Technically Unavoidable Particle Profile Guilde

beiwei5du

这个指南虽然是IPEC针对于辅料制定的，其结构同样适用于API（辅料在可见异物方面可能较API对制剂的风险更高，影响更大），其中要求辅料生产企业制定并完善“技术上无法避免的可见异物档案”，并最好和制剂企业分享，加强沟通，以至若辅料中出现此类技术上无法避免的可见异物时，能很好的完成评估以决定辅料是否放行。
这个指南和APIC的<Guidance on Handling of Insoluble Matter and Foreign Particles in APIs>结合看，后者主要针对于API的不溶和外来异物，和该IPEC指南有交叉也有互补性，同时虽然APIC指南针对于原料药，但是其指南结构上也适用于辅料。

Technically Unavoidable Particle Profile Guilde(技术上无法避免的可见异物档案指南）
http://101.247.67.17:9011/ipec.org/c3pr90ntc0td/sites/default/files/files/TUPP_GUIDE_2015.pdf

This guide is not meant to deal with foreign contamination or adulteration which can result from a failure of Good Manufacturing Practices.
This Guide is applicable to excipients used in the manufacture of pharmaceutical products.
This guide is focused on visible particles, not microscopic (sub-visible) particles.  
Excipients used in solid oral dosage forms are the primary focus of this guide.  The concepts presented may be applicable to other dosage forms after an appropriate risk evaluation is performed. The use of excipients in parenteral formulations requires additional consideration beyond the scope of this guide.  

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小金库

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