Development and validation of prefiltration bioburden testing

A lot of the work I currently do is related to aseptic manufacturing. In fact, most of the companies I work for, have products that need to be sterile and cannot be terminally sterilized. Therefore, a filtration step is involved to sterilize the bulk drug product. To build in enough sterility assurance in the process, the bioburden before filtration needs to be determined. According to the note for guidance, the bioburden needs to be NMT 10CFU/100mL, depending on the size of the filter and the v...
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Merry Christmas and a happy 2018!

Today was my last working day (on customer's location) before Christmas. The last few weeks I have been treated by my customres with several Christmas Diners, lunches, presents etc. I would like to thank all my customers for that. After some careful thoughts I have decided to not send any Christmas cards, but instead, donate money to charity. For each customer present, diner lunch etc, I will donate 75 euros. Since I know a lot of people who had to deal with cancer, or are still dealing cance...
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Regularly blog updates

Last week I went to the QP-forum in Budapest. This is a conference organized by the European Qualified Person Association (EQPA). It is always very well organized and great to meet fellow QPs of all countries of the EU. There is always the main conference, during which also a lot of time is always scheduled to answer questions that there might be out in the field. Next to that, there is always a preconference and as I am an IMP QP I always go to the IMP preconference. And during the main confere...
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Science vs quality

This morning I came across a nice article on the AAPS-blog. It describes a situation which I (as quality and science person) have come across quite often. And my answer was always better safe than sorry. Although I am not sure I performed the redundant work because of fear for inspectors or auditors. However, the article has a very nice last question: "What do you think? Should the companies be more proactive in assuring reduction of redundant work? And do you agree that redundancy impacts qu...
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