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The accuracy of serialization data and compliance by trading partners provides the foundation for compliance with the Drug Supply Chain Security Act (DSCSA). During the pharmaceutical packaging process, however, there may be unplanned events that jeopardize the integrity of the data, reduce productivity and increase operational costs.
Equipment jams, power failures, product damage during handling and operator errors will happen. Additionally, a product that is processed without incident may need to be removed from a pallet for periodic QA sampling. All of these events impact the many serialization-related requirements with which pharmaceutical manufacturers, repackagers and Contract Manufacturing Organizations (CMOs) must now adhere.
Factors that necessitate that packaging be reworked, and like many choices in life, you can either do it the hard (costly) way or the easy …