How to deal with Insoluble Matter and Foreign Particles in APIs

Foreign particles in Active Pharmaceutical Ingredients (APIs) and related intermediates is a topic of great interest to the pharmaceutical industry and quite often a matter of concern during authority inspections. There is a lack of guidance which has led to uncertainty of how to deal with insoluble matter.

The APIC has developed a "Guidance on Insoluble Matter and Foreign Particles" which intends to provide guidance to the API/intermediate industry for a standard approach on how to deal with the presence of foreign particles in terms of setting acceptable limits and acceptance criteria.

In the ECA Course "Handling of foreign particles in APIs" on 18 - 19 May 2017 in Barcelona, Spain, all relevant aspects regarding the control of particles in APIs will be discussed. Based on the APIC Guidance you will get to know how potential sources of insoluble matter can be identified and what good practices to minimise such particles can look like.

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