Wockhardt 483
Following on from my previous post regarding the multi product recall of Wockhardt products. This informative warning letter really opens your eyes to the observed actions within the factory. You have to ask where the QP oversight was and how these issues were not picked up during routine self inspection
GSK trial data issues
Yet more problems for GSK's China operations. In addition to the well publicised bribery case issues have now been raised with clinical trial activity within China. Namely the lack of pre-clinical data before products were given to human subjects.
Fresenius 483
Another revealing warning letter regarding an Indian manufacturing site. The attempt at hiding documents by stuffing them into pockets is a particular highlight. As with all these warning letters it is useful to get into the habit of using them as possible scenarios and how you would tackle them as a QP
TOC for Cleaning Validation
A useful 30min presentation/webinar on the benefits of using TOC for cleaning validation. You'll need to submit details to access the presentation (there is no confirmation email so you can put any email in the box)
Top 20 Orphan Products
As mentioned previously orphan drugs are rarely out of the news. Here is a great list showing the potential behind these lucrative drugs.
One for the Coffee Connoisseurs
Hence the reason copious amounts of coffee are available during DBA courses!
Happy Reading!
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