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

According to the latest EU report the number of counterfeit medicine packs seized when entering Europe in 2009 increased to 11,5 million - impressively illustrating the need for a harmonised European approach. But what does this mean for those involved in the manufacturing process or in the supply chain? Please read more here

In the past years the Bio Production Forum has been concentrating on taking a close look at the last stages of the development up to the production of biopharmaceutical products. As in the past years the conference this year again initiated the discussion of current regulatory developments and contributed to the understanding of the latest trends. Please read more here