GxP in the cloud

This article appeared in the "Algemeen Dagblad (utrecht Nieuwsblad)" on 02 April 2019. "The cloud is so easy to use. You can always access your data, you do not need to have a server standing in your own home. Just upload it and that is it." At least that has always been my thinking. Instead of having all my data locally on a computer, just store everything in the cloud and you can always access it. Last month I followed the ECA training on cloud computing in a GxP environment and lear...
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Brexit

A lot is going on at the moment concerning the Brexit. The UK is leaving the EU. This has quite some consequences for all types of industry. For the pharmaceutical industry this means that the EU rules and regulations no longer apply for the UK. Meaning the UK will become a so called third country. The consequences of this are tremendous. - if you currently have a market authorization for Europe. This no longer holds for the UK. - if you are currently producing (part of) your product in the UK...
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Container closure integrity (CCI) in the pharmacy

From April 10th until April 12th Pharmatech organized the "GMP/GDP 3-daagse". I was one of the invited speakers and gave a lecture about container closure integrity (CCI) in the pharmacy. My presentation can be found on slide share. Please contact me if you want to know more about this topic or if you want to discuss your strategy with respect to CCI.    
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Sterility assurance

Parental products need to be sterile when they are going to be administered. The best way to obtain this is of course by applying a terminal sterilization process with an overkill approach. This will give a very high sterility assurance for the product. However, nowadays, a lot of products cannot be terminally sterilized, since they will degrade due to the high temperature, or the high level of radiation during the sterilization process. To be still able to obtain a sterile product, the final bu...
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