Is AQL Testing required within the 100% Visual Inspection?

Is AQL Testing required within the 100% Visual Inspection?
One of the most frequently asked questions is whether an additional testing based on samples is required after the 100% visual inspection of parenterals. The answer is: basically, “yes”.

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One of the most frequently asked questions is whether an additional AQL testing based on samples is required after the 100% visual inspection of parenterals. The background for that question is the probabilistic nature of visual inspection. It is known that the discovery of defects (like for example particulates) is a matter of detection probability. In other words, visual inspection cannot exclude that defective containers may still be in the batch which hasn’t been sorted out. This applies to manual, semi-automatic and also automatic visual inspection.

The American Pharmacopoeia has reacted to that and has integrated AQL testing in the monograph Visible Particulates in Injections. Here, the value 0.65 has been…