Impurity testing
Since December 2014 ICH guideline Q3D (Guideline for elemental impurities) has reached step 4, meaning that the guideline is recommended for adoption to the regulatory bodies of the European Union, Switzerland, Japan,…
New regulation 536/2014 EC
In 2016 the new regulation 536/2014 EC will become effective. It will replace the current Directive 2001/20 about clinical trials. The document can be downloaded on the official site of the…
Presentation on FMEA
Today I came across an interesting presentation about FMEA. [slideshare id=14967973&doc=qualityriskmanagementfmea-121031093113-phpapp02]
Comments on the QP template are published by EMA
In 2011, the EMA has published two draft documents for a template for the QP's declaration concerning GMP compliance of the API used as starting material and verification of its…