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7 Nov 2013

News from the US on Particles in Injectables

Particles in injectable products are still a hot topic in 2013. According to FDA, almost one quarter of all recalls of injectable drugs during the last 5 years was caused by particles. It is likely that some of these recalls might have been avoided by a better visual inspection system. Also the number of "Forms 483" has increased. One reason is, for example, that FDA now checks whether the companies do supplemental inspections of products if a 100% inspection is not possible (for example, suspensions or products in opaque containers), as it is written in the USP. Another problem is the vague requirement for injectable products that every lot has to be "essentially free" from visible particles" in the USP <1>. The pharmaceutical industry still struggles with this wording.


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