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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Medication approval and safety processes

The EMA (the European Medicine Agency) has recently published some informative movies. In these they show what their responsibilities are with respect to patient safety. The first one is a general movie about the activities of the EMA: making sure that we receive safe and effective drugs. https://youtu.be/ShezrN2gs_8 The second one shows how a drug gets approved for the market. https://youtu.be/568SI1W-ekE The last one is about their pharmacovigilance activities. https://youtu....
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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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