APIC原料药中不溶性物质和外来颗粒处理指南

20151014 ECA新闻：APIC原料药中不溶性物质和外来颗粒处理指南  
The new APIC Guidance on Handling of Insoluble Matter and Foreign Particles in the Manufacture of Active Pharmaceutical Ingredients
新的APIC指南---处理原料药生产中的不溶性物质和外来颗粒
Foreign particles in APIs or medicinal preparations are undesirable and sometimes lead to a recall of the batches concerned. Depending on the type of particles their presence in active pharmaceutical ingredients may be harmless; in many cases they are inevitable. In any case the manufacturer must find an adequate way how to handle those impurities visible to the human eye. The search for a guideline or another official document in the relevant regulations is in vain. Visible particles or fibres are only mentioned in the USP chapter <790>, in chapter 2.9.20 of the European Pharmacopoeia as well as in the United States Food, Drug and Cosmetic Act (FD&C Act).
我们都不希望原料药或药品中有外来颗粒，它们有时会导致相关批次召回。依据颗粒物的类型，其出现在原料药中可能是无害的，在许多情况下，它们是无法避免的。不管怎样，生产商必须找到足够的方法来处理这些肉眼可见的杂质。查找指南或其它相关法规的官方文件找不到这样的指南。可见颗粒或纤维只在USP第<790>章中，在欧洲药典2.9.20中，以及在美国食品药品化妆品法案（FD&C法案）中有提及。
In order to remedy this lack of guidance or recommendations a group of experts within APIC has drawn up a guidance on the handling of foreign particles. This "Guidance on Handling of insoluble Matter and Foreign Particles in APIs" describes in detail
为了弥补指南和建议的缺乏，APIC的一组专家起草了一份处理外来颗粒物的指南。这份“原料药中不溶性物质和外来颗粒处理指南”详细描述了：
the types of particles which can often occur during the manufacture of APIs, API intermediates and raw materials (including packaging materials),  
原料药、原料药中间体和原料（包括包材）生产中经常会发现的颗粒物类型
suitable measures to minimize the presence of particles or to remove them,
将颗粒物出现的可能性降至最少或除去它们的适当措施
how to determine them analytically
如何采用分析方法来检测它们
how to identify the source and to carry out subsequent CAPA measures and an adequate risk management.
如何鉴定来源，如何实施之后的CAPA措施和充分的风险管理
This APIC guidance offers valuable assistance for all API manufacturers that are confronted with the problem of the occurrence of foreign particles in their products, intermediates or raw materials. The implementation of the very concrete and practicable recommendations in this guidance offers also valuable supporting arguments for GMP inspections or audits and can help to avoid unpleasant surprises.
这份APIC指南为所有面临产品、中间体或原料中外来颗粒物问题的原料药生产商提供了有价值的帮助。实施该指南中给出的具体可行的建议还能给出GMP检查或审计中非常有价值的支持性论证，可以有助于避免出现令人不快的惊奇。

来源：http://zhuyujiao1972.blog.163.com/blog/static/986947272015914113633689/