More than 70 lectures - mostly case studies from the pharmaceutical industry - as well as live demos and panel discussions were on the agenda of the well attended Pharma Congress end of March in Düsseldorf/Neuss. On the two Congress days everything revolved around current challenges, solution approaches and networking. Please read more here

The cGMPs merely state to exclude foreign matter and to minimize foreign particle content. The USP can provide further guidance with regard to definitions, methods, and limits for visible and subvisible particles, though. And this does not only apply to sterile injectable products, but also to biotherapeutic and ophthalmic products. Please read more here

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