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Electronic data exchange: a baseline survey summary

Electronic data exchange: a baseline survey summary

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.

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Guidelines for materials introduction supporting drug substance delivery

Guidelines for materials introduction supporting drug substance delivery

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.

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Industry proposal for a simplified registration process of complex and innovative raw materials in Europe

Industry proposal for a simplified registration process of complex and innovative raw materials in Europe

This paper proposes a solution, applicable to all innovative and complex raw materials, to the challenges the biopharmaceutical industry faces with the registration of complex and innovative raw materials in Europe. The biopharmaceutical industry has designed a direct solution to the issue and identified a way to higher quality regulatory submissions, enhanced knowledge, understanding, control and robustness of its products and processes.

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Single-use system audit guide

Single-use system audit guide

The single-use audit guide has been designed to help the auditor and auditee understand the areas of focus in SUS audits, referencing relevant requirements and SUS manufacturing ‘elements’. It is also designed to assist the auditor in reporting their assessment of SUS manufacturers to the end-user. It includes sections on general quality management system areas and products and production processes to consider. It is designed to be applicable to audits of single-use system manufacturers.

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Introduction to x-ray and gamma sterilization methods

Introduction to x-ray and gamma sterilization methods

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

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BioPhorum deliverables mid-year report 2021

BioPhorum deliverables mid-year report 2021

BioPhorum is here to help you make better decisions, faster in your operations. Membership puts you and your team at the center of current debates and helps you to stand shoulder to shoulder with those moving the performance dial on challenges that need a collective voice and a global perspective to resolve. The BioPhorum Deliverables Report is a consolidation of the benchmarks, position papers, guidance documents, assessment tools, industry...

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Raw Materials: Supplier change notifications: change areas and requirements

Raw Materials: Supplier change notifications: change areas and requirements

This guidance document identifies the relevant change areas, and for each area, exemplifies the type of changes which the biopharmaceutical industry needs to be informed about. It also lists the required information, in terms of supporting data and documentation, to support notification of changes. This guidance is relevant to all raw materials used to produce biopharmaceutical products, including but not limited to cell culture media, fermentation broth components, column resin, buffers, solvents, and excipients. By highlighting the changes biopharmaceutical industry end-users need to know about and specifying the information required, the intention of this industry-aligned guidance is to reduce the quantity of rework required and the time taken to process change requests. In turn, this will reduce variability in demand patterns as end-users refrain from building extensive inventories to mitigate against the perceived risks which arise from proposed changes. While complete alignment and standardization on the information which should be provided for changes is not possible, a more robust alignment on the typical information required, as set on in this guidance, will significantly improve the current state.

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Raw materials: Best practice guide for preparation of cell culture media solution

Raw materials: Best practice guide for preparation of cell culture media solution

The purpose of this best practice guide is to provide key information and best practices for media supplier partners and companies in the biopharmaceutical industry on the design, development and controls for manufacturing of media and medium solutions to minimize potential variation that may impact product quality, process performance and operational efficiency and costs. It is intended that it can be used to support a proactive approach to evaluation and self-audit of internal processes.

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Peer to peer practical guidance on remote inspections and audits

Peer to peer practical guidance on remote inspections and audits

Drawing on their real-world experiences, a group of experts drawn from 28 BioPhorum member companies has provided guidance on the detailed working methods that support a successful remote inspection or audit; for example, how to manage information flows between the inspectors and the site subject matter experts’ team. With the impact of Covid-19 likely to be seen for the foreseeable future, virtual inspections may be required for some time. This guidance will help all stakeholders prepare and to avoid the potential problems of remote inspections and audits.

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