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

During the last 5 years, various service providers developed multiple models for hosting services based on cloud computing. There is a big temptation for regulated organisations to consider such cloud services to reduce operational costs. However such decisions should be taken carefully since data are not only subject to GxP regulation but because they represent one of the most valuable parts of the company's capital. Please read more here

The tremendous developments and the increasing importance of biopharmaceutical products in the recent years made it necessary to review the EU GMP Guide's Annex 2. Please read more here