EMA has published a new Guidance on the sterilization of the medicinal product, active substance, excipient and primary container. The purpose of this document is to provide guidance on the selection of appropriate sterilization methods for sterile products. In general, terminal sterilization according to the … Read more

Data Integrity

In the last two years, national competent authorities from all over the world have focused more and more on Data Integrity. Different authorities have published draft guidelines: In April 2016, the FDA issued a first draft Guidance for Industry, “New FDA Draft Guidance Data Integrity and … Read more