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

Past February the European Medicines Agency issued a concept paper on the revision of Annex I of the EU GMP Guide. The new version is supposed to be harmonised with the ICH Guidelines ICH Q9 and Q10, but should also take into account new technologies in sterile production that has not been considered so far. This current development was one of the main topics at this year's Pharma Congress where about 1.000 delegates from the European pharma industry met. Please read more here