This BioPhorum member only paper provides an overview of the GS1 system of standards and its importance. It emphasizes that through wider industry adoption the GS1 system of standards has the potential to greatly improve communication, data sharing, and safety in the healthcare and pharmaceutical industry.
POI - Supply Chain to Patient
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This BioPhorum member only survey explores the challenges of the internal supply chain and the impact they are having on the business. One key theme that appeared to be emerging is that internal resource is a constraint within the supply chain for many companies.
BioPhorum has created a structure and approach to respond to the challenge of developing ePI solutions that add value to patients and healthcare providers alike highlighting the benefits and challenges of the broad range of factors surrounding the design and implementation of ePI, supporting the objective of finding a solution that can be implemented globally . The packaging perspective on ePI is simple: agree on an ePI format, and packaging functions can agree on how to apply it to product packaging. This paper looks at the opportunities and challenges and recommends the adoption and use of GS1 standards and recommendations both to meet supply chain and point of care needs and as a way to harmonize implementation of regulatory requirements.
Many biomanufacturers use a network of logistics service providers (LSPs) to deliver warehousing, transport and distribution services. Typically linked using customized, electronic, point-to-point connections. These connections can be expensive and slow to set-up and expensive to update in response to changing market demands. There is no dominant technical solution that monitors the condition and location of shipments, and that enables companies to adopt different solutions for different regions and partners. There is a need to raise the awareness of software vendors of this unmet need and the real interest of many industry stakeholders if a suitable LSP integration solution was available.
This paper provides an overview of the current needs of manufacturers and their technical integration with their network of LSPs. It contains a high-level requirements specification for a common, cloud-based, integration platform, that would reduce customization and multiple point-to-point solutions. The specification is designed to help technology companies develop this services. Informal benchmarking across member companies indicates that ‘collaboration hub’ use would deliver a 50–70% saving in time and cost when linking to a new partner. These benefits would be realized by both partners making the new connection.
Shipping lane validation or qualification of thermal protection systems is not a simple task. Each pharmaceutical company and regulatory body use different standards leading to inconsistency. Vendors also do not have a standard for the specific tests that customers require. This absorbs huge amounts of resources for qualification testing, where work is unnecessarily repeated and existing data is not leveraged. To address this, the guidance details a best practice for standardized shipping lane validation that can deliver an annual saving of between $0.5m and $1m per shipping solution, a 50% reduction in resource requirements, and a reduction in product submission timelines by as much as 6-12 months.