NEW GS1 HEALTHCARE GUIDELINES – ARE YOUR MANUFACTURING PROCESSES COMPLIANT?

Through its implementation of standards, the GS1 System facilitates the ability of the healthcare industry to maintain an efficient supply chain worldwide due to uniquely identified products, logistic units and locations. The standards that they set are global, neutral, non-ambiguous and non-significant.

Their purpose is to allow product and data flow between the various partners along the supply chain including suppliers, manufacturers, wholesalers, logistics providers, transporters and hospitals just to name a few. Their processes and procedures also help automate data capture and data management, increase data flow, reduce cost and secure the supply chain.

Last month saw the release of Version 3 of the Automatic Identification and Data Capture (AIDC) Healthcare Implementation Guideline which updated its standards and added new sections on Human Readable Interpretation (HRI) and updated Direct Part Marking (DPM) which will be implemented across the industry over the coming months.

The full document can be found here.

AIDC Standards for Healthcare trade items have also been incorporated within the GS1 General Specifications. The outcome of this will have huge implications on the Healthcare industry by providing stakeholders with a shared set of data and data carriers to be applied to medical products at every packaging level. The AIDC Standards also offer specific guidance for manufacturers on the selection and use of:

Suitable GS1 Product Identification Keys

  • Additional product and production data (batch/lot numbers, expiration dates and serial numbers)
  • GS1 Data Carriers, which include linear bar codes, two-dimensional bar codes and Radio Frequency Identification (RFID) tags

The Application Standard for AIDC in Healthcare was developed to target approximately 80% of the Healthcare products currently in the global marketplace. Future efforts will target additional AIDC marking needs.

The AIDC Healthcare Standards support the ability for sector-wide implementation of AIDC systems which are aimed at improving patient safety, reducing medication errors, facilitating anti-counterfeiting and enabling effective product recalls. The approved systems will also aim to address inefficiencies throughout the global Healthcare supply chain and allow stakeholders to improve and integrate their processes.

Eagle are experts in ensuring compliance and safety throughout the supply chain in your medical manufacturing. To speak to us regarding the changes to the GS1 / AIDC Standards, or for any other issue relating to life sciences manufacturing, please get in touch with a member of our team.

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