The US Food and Drug Administration (FDA) released the Standardisation of Data and Documentation Practices for Product Tracing guidance last week, which extends the standards outlined in the Drug Supply Chain Security Act (DSCSA).

A completely electronic system should only bring advantages to CMOs and the wider industry, improving data integrity and security.

The DSCSA aims to establish an electronic system for the tracing of medicines in the US. As well as protecting patients from counterfeit medicines, the DSCSA is also expected to bring new efficiencies to the supply chain. Staffan Widengren, Recipharm’s director corporate projects comments on this latest DSCSA announcement in in-Pharma Technologist.

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US FDA track and trace: Industry welcomes data standardisation