Main topic of this conference is the detection of particles in injectables and their evaluation during batch release and continuous process improvement. It takes place on 10-11 October, 2018 in Hamburg, Germany.
API manufacturers who want to make changes to the API manufacturing process during an application's post-approval period should read FDA´s new draft guidance for industry: Postapproval Changes to Drug Substances.
In April 2018, the CMDh published a document to clarify questions which arose from the original Q&A document dated March 2017 on the implementation of the Falsified Medicines Directive. Read more about the document "CMDh clarifications on questions received on the implementation of the Falsified Medicines Directive".
The safety features required for the implementation of the Anti-Counterfeit Directive will have to be implemented by the 9th February 2019. The European Commission released version 10 of the questions and answers catalogue on safety features in July 2018. Get more details about the revised Q&A document of the EU on safety features.