Discussions among the delegates of the 16th European API Conference past November in Madrid were quite vivid. The more this showed that there is a need for communication between the two sides - industry and authorities - as well as among themselves. Please read more here

According to the pharmacopoeias the inspection of medicinal products for parenteral use has to be carried out in 100 % of the cases. Notwithstanding the requirements laid down in the pharmacopoeias and in Annex 1 there are still lots of open questions for manufacturers as various points are not described sufficiently. Please read more here

The concept for Total Process Quality Improvement (TPQI) has been developed for implementation of ICH Q10 as a Pharmaceutical Quality System. In the first part of this article you will get an overview of using Quality Cycles for ICH Q10 implementation. Please read more here

As of 2 July 2013, all active substances imported into the EU need to be accompanied by a Written Confirmation that they were manufactured in accordance with European Good Manufacturing Practices (GMP) or according to equivalent rules. However, many countries outside the EU have not yet commented yet whether - and if yes, when - they will issue these Written Confirmations. Please read more here