One of the central issues at the Conference "The new Pharma Directive" in October was the industry's fight against counterfeiting. By publishing the Directive 2011/62/EU the EU has issued a document extending the Directive 2011/83/EC with specifications for containing counterfeit medicines. Please read more here

A global pharmaceutical supply chain and the quality issues as a result of this globalization, the 21st Century FDA initiative and resource constraints are changing the way the American authority envisions inspections of non-US production sites. Please read more here

As APIs are becoming more and more potent, as health and safety authorities worldwide increasingly pay attention to protecting operators dealing with these substances and as a decision on the optimal containment solution is more difficult due to the variety of solutions, containment frequently becomes an issue with regard to solid dosage form production. Please read more here

Since CAPA has been implemented in guidances like ICH Q10 and the FDA Quality System Guide, the supervisory authorities' expectations also increase. An appropriate CAPA system provides the opportunity to continuously improve GMP processes. Please read more here