Visual Control by Doctor and Patient?

To avoid supply bottlenecks, batches of lyophilisate manufactured by the company Jazz Pharmaceuticals which possibly contain visible particules are to be visually checked before administration and additionally filtered through a 5 µm strainer. The Bundesamt für Arzneimittel in Germany (BfArm) states that an inspection of lots 179 and 180 revealed particulates on the plugs and possibly the lyophilisate itself. The affected vials had been sorted out. To ensure market supply however, several bottles have been released now with the notice that the content is to be filtrated with a 5 µm filter needle.

According to the manufacturer Jazz Pharmaceuticals, it is to be examined before reconstitution whether the particulates only appear on the underside of the plugs and not the lyophilisate, i.e. the product itself.

The reconstituted solution should be free of particulates; a subsequent filtration is to make sure of that. According to the manufacturer, the additional filtration does not affect the product's quality.

That is interesting considering that in a Q&A document, the European Medicines Agency rules out filtration as a procedure for particle removal ("Particles originated from the container closure system"). The example above is about particulates due to glass delamination and the routine addition of filtration to the instruction leaflet. According to the EMA, it shouldn't be the patient's task to ensure the quality of a product; this is the manufacturers' duty. The difference is that in the case of Jazz Pharmaceuticals the described measures are only temporary and not for routine.

The original notification can be found on the BfArm's website.

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