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EU23CEDEC1/SES401 - Delivering a GPG for Container Traceability in 2024

‐ Dec 12, 2023 10:00am

Modern parenteral manufacturing operations are driving the need for greater precision and visibility in each process to supplement traditional control strategies. These data-based decisions can reduce risk, accelerate drug delivery, and improve patient safety. The ISPE have established a working group under the umbrella of the SCOPE Community of Practice. The group comprises of sixty-seven [67] stakeholders across the industry who account for around 80% of the manufacturing capacity. The aim is to publish a Guidance Document in Q1 2024 which is designed to support pharmaceutical manufacturers with the implementation of unique containers in their manufacturing operations. This presentation will cover a range of topics across the pharmaceutical supply chain, illustrated with uses cases and key learnings. It will demonstrate why container traceability is crucial for process optimisation success and to maximise the original return on investment?


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