1) How are people trained to perform the visual inspection? 2) Are inspector's trained using standard samples?

3) If standards are used, what is the acceptable variation between inspectors to deem them trained? (i.e. How many vials can they miss fr om the standard set ?) 4) What is the maximum and minimum length of time for viewing each sample? 5) Is viewing for foreign particulate matter performed on the settled sample, the dispersed sample, or both? 6) How many foreign particulates in a vial or syringe are allowed before the vial/syringe is rejected? 7) What is the maximum percentage of rejected vials/syringes acceptable in a batch?

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