Abstract—This paper describes quality risk analysis in the dispensing center where all required medical substances of each formula are weighted, checked, and verified before transferring to the production line. Like any working station, risk in terms of both information and operations can take place here. Thus, all of these risk opportunities must be identified and evaluated and the possible prevention and protection measures must be devised to avoid these risks. Based on the analysis in the case study in this paper, there are a number of potential risks and four of them are shortlisted with recommended alleviation actions.
Index Terms—FMEA in pharmaceutical, FMECA, pharmaceutical dispensing center, quality risk management.
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