Exception Management in Pharmaceutical Industries to attain DSCSA Compliance
Abstract
Drug Supply Chain Security Act (DSCSA) was introduced by USFDA to identify and remove the harmful drugs from the commercial distribution for patient safety. The traceability of the saleable units needs to be maintained from drug product manufacturer to dispenser by all authorized trading partners, using interoperable electronic data transmission i.e., EPCIS (Electronic Product Code Information Services) files to their downstream trading partner. EPCIS files contain overly complex data sets containing product master data, trading partner`s master data and fully aggregated serialization data for the drug product from saleable unit till case level/shipper level. Due to complexity of the EPCIS files, probability of the failure is remarkably high for unsuccessful transmission, which lead to quarantine that drug product and restrict the further distribution. Any aggregation issues or data issues from the EPCIS files need to be identified, investigated, rectified, and needs to be documented, that procedural approach handled by using exception management systems. If root cause cannot be identified and traceability of the product come into question, then it may fall in to suspect / illegitimate product and trading partner(s) need to notify USFDA, cannot sell further and need to keep that product into their possession under quarantine. If root cause identified and corrected EPCIS files received by the purchasing organization, then the product can be further commercially distributed. Ultimately its drug product manufacturer`s responsibility to have adequate exception management procedure and system in place to stay compliant.
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References
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/dscsa-standards-interoperable-exchange-information-tracing-certain-human-finished-prescription-drugs
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