This paper summarizes the industry position and aims to start a strategic discussion on this situation. It will help ensure we have a common language and understanding across industry. Looking ahead, we will emphasize shared learning, best practices, and retrospective investigations to improve long-range planning processes
POI - Supply Partner
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The future of the inbound supply chain: implementing electronic data exchange (EDE)
Oct 2022 | COVID 19, Deliverable, Deliverables Report, EDE/Digitization of the In-Bound Supply Chain, POI - Supply Partner, Publication, Supply Partner
This paper proposes that shared and electronic data exchange (EDE) is a cornerstone of collaboration and innovation in the supply chain. The paper aims to demystify EDE, set out its importance for supply chain effectiveness, capture its benefits and help people understand the practical enablers.
Current and near-future bioprocess supply situation and trends post COVID-19
Oct 2022 | COVID 19, Deliverable, Deliverables Report, POI - Supply Partner, Publication, Supply Partner
This paper provides an overview of the current and near-future bioprocess supply situation and trends. This research provides insights into how the industry has adjusted as the Pandemic begins to abate.
On time in full (OTIF) high level guidance
Jul 2022 | Deliverable, Deliverables Report, POI - Supply Partner, Publication, Supply Chain Quality Management, Supply Partner
This paper provides an introduction and a high-level view of on time in full (OTIF) so that when we use the acronym, we know how it is calculated and are all using it in the same way. It examines detail on the components of ‘Actual orders delivered’ and ‘Expected orders to be delivered’ and talks about the information included, actions to take and gives tips on how to best use each component.
Supply chain quality management optimal process and RACI
Jun 2022 | Deliverable, Deliverables Report, POI - Supply Partner, Publication, Supply Chain Quality Management, Supply Partner
These tools support sharing the optimal high-level steps to simplify a process and invite people into the discussion using a common language. The optimal process outlines the essential process steps and for each one lists the ‘who’ (i.e., which role) and the ‘how’ (i.e., what medium). The RACI supports people to understand where accountabilities and responsibilities lie.
Forecast and demand planning optimal process tools
May 2022 | Deliverable, Deliverables Report, Forecast and Demand Planning, Forecast and Demand Planning, POI - Supply Partner, Publication, Supply Partner
Suite of deliverables to support the forecast and demand planning process and complement the FDP Toolkit. They include an optimal process, RACI and template. These areas are where there is potential for the greatest benefit and will create value for industry when used correctly.
Electronic data exchange: a baseline survey summary
Nov 2021 | Deliverables Report, EDE/Digitization of the In-Bound Supply Chain, POI - Supply Partner, Publication, Raw materials, Supply Partner
A benchmark survey which sets out to establish the baseline for electronic data exchange across participating members, to understand: How suppliers and biomanufacturers were working with EDE for raw materials across their inbound supply chain, whether they were using the ASTM standard and, if so, its application and value to their company and to provide Insights for improving EDE across the sector. The results cover utilization, prioritization, ASTM E3077-17 standard utilization and the benefits and challenges in implementing it, EDE maturity, benefits and challenges for EDE in the inbound supply chain, EDE accelerator and other conclusions.
Guidelines for materials introduction supporting drug substance delivery
Nov 2021 | Deliverables Report, Drug Substance, Forecast and Demand Planning, POI - Supply Partner, Publication, Supply Partner
A standard process map providing industry with a set of simple tools containing a structured approach for materials introduction across the supply chain. This paper summarizes a stepwise process that can be used as a guideline for introducing a material to support new drug substance manufacture and can be used in conjunction with detailed, company-specific NPI procedures. In addition it is relevant best practice for cell and gene therapy manufacturers.
Introduction to x-ray and gamma sterilization methods
Aug 2021 | Alternative to Gamma, Deliverable, POI - Supply Partner, Publication, Supply Partner
The BioPhorum Alternative to Gamma Sterilization workstream is focused, in partnership with the Bio-Process Systems Alliance, on raising awareness of the need for sterilization alternatives for single-use systems. As part of this work the team discovered a need to understand some of the first principles. This paper is to provide a lay person’s introduction to the need for change, the basic physics involved and a high-level comparison between x-ray and gamma
Supply Chain Quality Management: Pilot program summary
Jan 2021 | Deliverable, POI - Supply Partner, Publication, Supply Chain Quality Management, Supply Partner
Over the course of 14 months, eight site audits were carried out on BioPhorum’s Supply Partner supplier member company sites and these were made available for industry to license via the Rx-360 website. The audits were conducted through the Rx-360 Joint Audit Program and its audit partner BSI. This report details the methodology of the approach, the feedback and the findings of all the stakeholder groups involved and the reviewer panel involved in the pilot program.