HDA Guidelines for Bar Coding in the Pharmaceutical Supply Chain
The 2022 revision serves as an industry-wide voluntary resource on the use of globally accepted GS1 system data structures and symbologies to comply with the Drug Supply Chain Security Act (DSCSA) to convey the required serialized data in product identifier, along with presenting options for non-serialized products.
The guideline recently revised in April 2022.
Below is a list of significant changes from the 2017 HDA Guidelines for Bar Coding in the Pharmaceutical Supply Chain:
- Clarifies abbreviation and expiration date formats based on industry practice, updated guidance documents from the USP on labeling coming into effect in 2023 and the Food and Drug Administration (FDA) guidance documents.
- Addresses FDA final guidance, “Product Identifiers under the Drug Supply Chain Security Act – Questions and Answers,” including human-readable NDC;
- Includes requirements for four data elements of a product identifier mandated by DSCSA;
- Provides recommendations for encoded elements, order of encoding and human-readable interpretation (HRI);
- Makes recommendations and specifications for inner-packs and corner-wraps, respectively;
- Updates partial/mixed case recommendations; ? Recommends use of UPC-A to comply with the bar code rule in retail settings;
- Includes updated links to the 2021 GS1 General Specification; and,
- Includes updated images and figures to display current recommendations, with a summary specifications table for serialized and non-serialized products
Agente comercial
1 年Indeed, the 2022 revision is a key resource for the pharmaceutical industry. It's essential to note that the GS1 system not only aids in compliance with DSCSA but also improves the process efficiency. The use of standardized data structures offers visibility and traceability throughout the supply chain. As for non-serialized products, options such as batch-level identifiers could be a feasible approach. The aim is always to ensure the integrity of the product and eventually, patient safety. #PharmaSupplyChain #PatientSafety #GS1 #Efficiency
Managing Consultant at NNIT GmbH
2 年Thanks for sharing.