Primary packaging for medicinal products requires special attention to possible interactions with the content as well as to the protection of the content and safety aspects during the following application. Great care is therefore necessary when choosing the materials for their manufacture or in the selection from offers already on the market. What regulatory specifications have to be considered is covered in part I of this article. Please read more here

The avoidance of cross contaminations was one of the important subjects in the past years. A robust cleaning validation and the definition of health-oriented exposure limits were identified as effective measures against these cross contaminations. The EU GMP Guide requirements to this effect were modified respectively. Please read more here

Through self inspections pharma companies can monitor themselves how they apply and implement GMP requirements, they can possibly uncover deviations and propose necessary corrective measures. But what exactly has to be considered when conducting internal audits? Please read more here

To discuss the specific requirements for IMPs the European QP Association's IMP QP Working Group offered its first pre-conference as part of the 2007 QP Forum already. By now it has become a well-established part of the annual Forum and regularly attracts IMP QPs from all Europe. Please read more here