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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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Supply Chain Quality Management: Pilot program summary

Supply Chain Quality Management: Pilot program summary

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.

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Forecast and Demand Planning: Communications pack, planning checklist and forecasting template

Forecast and Demand Planning: Communications pack, planning checklist and forecasting template

The checklist is a best practice checklist to define the recommended minimum required steps to generate a useful forecast. It is for companies moving towards mature demand forecasting practices, and biomanufacturers and suppliers with regular demand forecasting meetings. It should be used each time a new forecast is generated to ensure the key steps are carried out. The communications pack explains the recommended forecast and demand planning cycle of events, i.e. when you should sit down and talk, what you should talk about, what should be in the discussions, etc. This will help guide and structure the regular meetings between biomanufacturers and critical suppliers. Having a comprehensive framework for those meetings is essential, especially when discussing key materials. It includes everything from the minimum required agenda items and an action log template, to a forecast confidence ‘traffic light’ indicator and ‘hints and tips’ to get the most out of the pack.

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Risk and Business Continuity: Risk management in the biologic industry supply chain

Risk and Business Continuity: Risk management in the biologic industry supply chain

This best practice guide to risk management in the biologics industry supply chain is based on the premise that adoption and implementation of the principles and framework reflected in ISO 31000 (Risk Management: 2018) provide an effective and efficient way to support biologics industry growth while maintaining, and potentially increasing, benefit to patients and companies, in addition to satisfying the demands of regulatory agencies and meeting legislative requirements. It is designed to encourage the industry to review their approach to risk management to validate, or refine and improve, current company practice, in terms of principles and risk management processes in this vitally important business function.

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Disposables: Single-use systems bag assembly leakage and defect toolkit

Disposables: Single-use systems bag assembly leakage and defect toolkit

This toolkit gives users a set of tools to respond to problems and materials to include in their communications and operator training.It will help reduce product losses, investigations, manufacturing disruptions and the number of leaks. It equips industry with tools to help standardize the vocabulary around SUS anatomy and processes and expand its understanding of SUS abnormalities.

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Raw Materials: Trace element variation of soy hydrolysate used in biopharmaceutical manufacturing

Raw Materials: Trace element variation of soy hydrolysate used in biopharmaceutical manufacturing

It is important for biomanufacturers to understand trace element variation within soy hydrolysates (by knowing the minimum, maximum and average concentrations), so they can determine if the degree of variation has an impact on their process. The knowledge gained through process characterization across the maximum variation found in soy hydrolysates can be evaluated to determine if it has an impact on the biomanufacturers’ process or product on a product-byproduct basis.

This is the first in a series of proposed hydrolysate white papers. The purpose is to educate users of hydrolysates of the various characteristics that they should be aware of to manage their processes. There are many parameters to consider within a hydrolysate. The intention is to start with data that can be collected on as many different hydrolysates used in the biopharmaceutical industry.

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TVR: Determining testing validation and release requirements for single-use systems through risk assessment

TVR: Determining testing validation and release requirements for single-use systems through risk assessment

When testing single-use items for biopharmaceutical manufacturing, when is it appropriate to leverage vendor data, and when does the end-user need to carry out testing? Is current regulatory guidance clear and sufficient in the fast-moving area of disposables? This best practice guidance has been developed as one of a suite of tools designed to assist the industry in providing a risk-based approach to testing requirements.In the rapidly evolving area of single-use systems (SUS), the industry will benefit from standardization while leveraging risk-based approaches to testing requirements to ensure compliance of parameters that are important for the process and product quality. This document establishes best practice guidance on how to use risk-assessment methodology to evaluate the level of testing needed to qualify and release SUS.

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Change Notification: A guide to change notification packages for single-use manufacturing systems

Change Notification: A guide to change notification packages for single-use manufacturing systems

This paper is intended to be an all-inclusive manual (a one-stop shop) on change notification best practices for single-use biomanufacturing systems. A summary of previous publications is also provided. This includes improvement updates to the decision tree and supporting table based on user feedback. This paper delineates the main attributes of an effective supplier change notification program. The team’s vision for this toolkit is to facilitate adoption of these practices by the majority of end-users and suppliers in the single-use supply chain. In time, it is hoped that these practices will become reflected in quality management practices and in formal business agreements.

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