risk management

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How to replenish working cell banks with a risk-based scientific approach

Cell banks represent the fundamental starting substrates for biological drug substance/drug substance intermediate manufacturing. So, the availability of well-characterized cell banks capable of supporting manufacturing processes is critical for an uninterrupted drug product supply to patients and global markets.  This is why two-tier cell banking systems are developed, consisting of master cell banks and...

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How do you manage risk in your supply chain?

The biopharmaceutical supply chain is global and complex, and disruptions can quickly have an impact – you only have to look at COVID-19 to see the importance of maintaining surety of supply. So, it is critical that manufacturers, tier 1 suppliers and their sub-tier suppliers understand the risks in their supply base and deploy effective and consistent risk management systems to reduce their exposure to problems. Unfortunately, a range of...

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Isolator glove management evaluation of regulatory guidance and framework of recommendations

The loss or delay of a batch for glove failure and uncertainties of glove management are perennial concerns for aseptic filling operations. Written by a team of industry practitioners who create, justify and manage glove programs, this guide defines current best practice and the actions we can all take to reduce risk. Specifically it enables users to understand glove-related risks, facilitating deviation investigations and building confidence when presenting to inspectors. Helps users understand the rationale for supplier recommendations about glove lifecycle management. Reduces the need for users to develop their own glove lifecycle management strategies and standardizes the language for collecting data in and across companies, that will support future benchmarking and improvement.

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Raw material: A holistic approach to raw material risk assessments through industrial collaboration

It is impossible to define the raw materials used in the biopharmaceutical industry with a single set of regulatory or compliance criteria. What is considered fit-for-function changes depending on the product attributes and the intended customer. This tool standardizes and structures the risk assessment process, addressing three fundamental questions when determining raw material fit-for-function: What user requirement is the raw material designated to perform? What material attributes are essential to the designated function and what might have unintended consequences? This paper helps improve communication between – and within – manufacturers and suppliers and enables users to make uniform, evidence-based decisions on risks and priorities concerning raw materials. An industry-wide methodology for the resolution of high-impact raw material variability issues.

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Product changeovers (PCO): Guidelines for risk based changeover of biopharmaceutical multi-product facilities

Product changeover is a process that prepares and configures the facility and equipment for the next manufacturing process, and includes actions taken to protect the subsequent process against contamination from the previous process. Historically, the change-over between two products within a multi-product facility has created a great deal of operational inefficiency. This paper shows how with the use of risk-based tools and supporting data, the changeover activities of multi-product facilities can be significantly reduced and, under well-controlled and characterized operations, concurrent manufacturing may be achieved. Specifically, the change-out of small parts and elastomers as well as the collection of changeover cleaning samples may be significantly reduced or eliminated. This article is primarily intended for the manufacture of bulk biologic drug substance; however, the principles may be applied to finished drug product as well.

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Supply chain mapping: A best practice for the biopharma industry

The complexity of the support networks needed to deliver biopharma products, makes good supply chain mapping (SCM) essential to ensure reliable drug product supply.  This is especially the case given the impact that natural disasters, adverse weather and politics can have on supply chain security.

This guide from the Supply Chain Mapping workstream can be tailored to the needs of both suppliers and manufacturers and helps them map and master supply chain risk.  The guide details reasons why companies should adopt the approach, an implementation model, a standardized questionnaire to collate and manage basic supplier data and a maturity model against which a company can assess its own level of supply chain mapping and understanding.

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Biomanufacturing technology roadmap: 8. Supply partnership management

This chapter of the First edition biomanufacturing technology roadmap published in 2017, describes the vision, scope and benefits that could be gained in the biopharmaceutical manufacturing industry from the development and adoption of effective supply partnership management approaches to develop the critical suppliers for the industry. To help the industry achieve this future state it describes the scenarios considered, the future needs, challenges and potential solutions as well as the linkages and dependencies on other parts of the roadmap. It considers the contribution that disruptive and emerging technologies can play and regulatory considerations before finalizing with conclusions and recommendations.

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Closed systems: Response to Annex 2

This paper is an interpretive response to Annex 2 of Eudralex—Volume 4; the European Union (EU) guidelines for good manufacturing practice (GMP) of medicinal products for human and veterinary use.  The purpose of this paper is to share an interpretation of key areas of Annex 2, providing enhanced clarity for the industry. This paper supports a scientific and risk-based approach that identifies the biological active substance manufacturing requirements, and the types of control that meet those requirements.  Its focus is around use of a QRM approach to assess environmental control requirements for a low bioburden drug substance process, and that use of closed systems is an effective way to reduce risk and this minimize need for environmental controls.  Use of closed systems in reduced area classification enables a significant reduction in costs for the industry.   

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