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

Whenever an unplanned event results in a deviation, it must be handled accordingly. And the appropriate handling of these deviations presuppose a clear understanding of the steps involved in managing them. 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

In the past, when pharmaceutical companies had multiple manufacturing facilities and distributed their products locally, little attention was paid to product storage and distribution. Introduction of the EU GDP Guidelines in 1994 was an important first step, both for the regulators and for the industry. Now these Guidelines are being revised - bringing along some consequences for industry. Please read more here