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Deviation Management (DMS): Guide to implementing a risk based deviation management system

Deviation Management (DMS): Guide to implementing a risk based deviation management system

BioPhorum has developed a risk-based deviation management system (DMS). 13 member companies have implemented this approach, and summary data from these companies shows improved quality performance plus an average time saving of 22,200 work hours per site per year, which is equivalent to a $888k cost saving.

This guide outlines the work of the BioPhorum DMS Workstream in defining and creating a simplified and effective risk-based deviation management system with advanced RCA methodologies, and a track-and-trending process of low-risk events. It includes everything required to build a risk-based approach to DMS, including the business case for change, the new process, risk-based tools, and a detailed sharing of post-implementation benefit.

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How industry is returning to work during the covid-19 pandemic

How industry is returning to work during the covid-19 pandemic

BioPhorum’s covid-19 Workforce Protection Survey was completed by the Senior BioPhorum Connect group, consisting of leaders and sponsors from the BioPhorum communities. It assessed how industry was reacting to covid-19 to identify and share best practices that would help guide its reaction to the crisis. This article looks at the detail of return to work (RTW) and asks specific questions on how the Senior BioPhorum Connect group is addressing issues such as the RTW criteria, phased approaches and a possible ‘return to lockdown’.

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Cyber security: Information technology vs operations technology – a BioPhorum article

Cyber security: Information technology vs operations technology – a BioPhorum article

This paper characterizes this framework, and the associated mixed environments, to illustrate the drivers and success metrics for the key functions of business management of information systems, and that of plant-floor instrumentation and controls engineering. For people working in this arena, this paper will help develop an understanding of this landscape and foster a cooperative approach to implementing network resilience and cybersecurity solutions that allow more robust and secure delivery of essential drug products to the market.

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Cyber security: Digital plant resilience assessment tool

Cyber security: Digital plant resilience assessment tool

As the maturity of digital manufacturing plants increases, so does the risk of a cybersecurity or other digital incident. A successful phishing attack, for example, could adversely impact manufacturing operations and potentially take a facility offline for hours, days or even longer.  A company’s ability to minimize the risk of a digital disaster in its manufacturing plants, and quickly restore operations if one occurs, is a vital area for investment to ensure delivery of drug products to patients. To do this, biopharmaceutical manufacturers must understand the cyber resilience at their differing plants and how each site fits into the context of their overall business.

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Extractables testing of polymeric single-use components used in biopharmaceutical manufacturing

Extractables testing of polymeric single-use components used in biopharmaceutical manufacturing

This revised extractables protocol for polymeric single-use components in biopharmaceutical manufacturing is based on an extensive scientific review and represents the combined opinion of the biopharmaceutical manufacturers and, crucially, the supply chain. It will reduce costs and focus people on the important data points. The protocol provides guidance on the suggested methods for extractables studies, including sample preparation, extraction conditions, recording test-article sampling conditions, and reporting data from the analysis of extracts. Flexibility is built-in, allowing suppliers to alter many study parameters due to restrictions based on the use of SUS, physical form factor, chemical compatibilities, etc.

The new protocol includes significant changes to the 2014 version, including the removal of 5M sodium chloride and 1% Polysorbate 80 as extraction solvents, the elimination of the time-point zero interval, and the elimination of elemental analysis of 50% Ethanol extracts.

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Knowledge mapping for the biopharmaceutical industry: A test case in CMC business processes from late-stage development to commercial manufacturing (paper and tool)

Knowledge mapping for the biopharmaceutical industry: A test case in CMC business processes from late-stage development to commercial manufacturing (paper and tool)

The management of knowledge in biopharmaceutical organizations has been recognized as an important challenge over recent years. Defining the pain points and designing successful knowledge management (KM) solutions have proven difficult. To address this challenge, BioPhorum Technology Roadmapping applied a KM best practice methodology to capture a process-based knowledge map for a major business process; this was performed by companies who develop and commercialize new therapies. The resulting assessment of knowledge flows revealed that there are significant challenges to both explicit and tacit knowledge flow across the control strategy and method development / technology transfer processes. Some generalized solutions have been proposed. As part of this work, a detailed spreadsheet tool was developed so that organizations can repeat this work on their business processes to understand their knowledge–flow issues and develop fit-for-purpose solutions.

The knowledge mapping tool is available here. Detailed instructions are available within the tool itself. The data in the sheet reflects that used in the illustrative example documented in the companion paper. The data is intended to be removed and replaced with end users data in support of their own KM efforts.

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China: Registration of raw materials entering the composition or presentation of biopharmaceuticals

China: Registration of raw materials entering the composition or presentation of biopharmaceuticals

Since 2017, it has been mandatory for suppliers of APIs, excipients and packaging materials to register their material in China on the DMF registration platform. While many agencies ask for details of a component’s quality and its impact on products, the Chinese requirements for ‘high risk’ materials, such as those used in biopharmaceuticals, also ask for historical information that is typically proprietary which many suppliers are reluctant to share. This paper summarizes the requirements for raw materials in other ICH countries and compares these to the Chinese approach. The paper also lists all of the details needed for the Chinese registration of biopharmaceutical products’ raw materials in a single place, to help suppliers register their products into this vast market.

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Product changeovers (PCO): Biopharmaceutical industry position on European Medicines Agency (EMA) guidance and expectations at product changeovers

Product changeovers (PCO): Biopharmaceutical industry position on European Medicines Agency (EMA) guidance and expectations at product changeovers

The EMA guidance, ‘Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities’ goes against current best practice for product changeovers (PCO) in the biomanufacturing industry, This paper is a response that sets out the currently accepted practices and controls in an evidence-based justification to help companies validate and continue working towards their implementation. The paper promotes: limited or no sampling at PCO, supported by cleaning validation, the use of alternative methods for calculating limits, eliminating the need for a health based exposure limit (HBEL) calculation, the necessary use of additional programs (e.g. eye-sight testing) and the generation of a robust risk assessment that align with industry practices.

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Single-use user requirement (SUUR) toolkit

Single-use user requirement (SUUR) toolkit

Single-use technology is growing fast in the biopharmaceutical industry, but designing new single-use systems involves a long, iterative process between end-user and supplier to ensure quality, regulatory, and technical requirements are met. Wouldn’t it be convenient if all these requirements were captured in a toolkit? BioPhorum and BPSA have created templates aligned with industry standards (i.e. ASTM E3051) which will simplify the single-use design process. The Single-Use User Requirement (SUUR) Template helps end users to communicate process/application details and SU requirements to suppliers, who in return can affirm or describe their capabilities to meet these requirements. The Technical Diligence Templates are pre-populated with end-user requests for detailed information that describes how suppliers may fulfil specific user requirements. Supplier responses allow end users and suppliers to make informed decisions and reduce gaps in understanding. The Supply Chain Template allows end users to request supply chain-related information and gives suppliers with a dedicated document to respond to this request. These templates combine to provide the industry with a set of common user requirements, clarity on criteria for fulfilling these requirements, and a mechanism for transmitting supply chain-related information. Adoption of these templates will yield distinct advantages to both end-users and suppliers in terms of compliance, time, and efficiency. Quality and compliance is improved by documenting and aligning expectations. Further, the tools enable clear and consistent communication, fostering a right-first-time approach to the design of single-use components.

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Modular and mobile: Improving the biomanufacturing facility lifecycle using a standardized, modular design and construction approach

Modular and mobile: Improving the biomanufacturing facility lifecycle using a standardized, modular design and construction approach

Traditionally, biopharmaceutical facilities can take up to three to five years from design through qualification before they are ready for full operation. Such facilities are often product dedicated, requiring significant and costly modification to accommodate additional products once the original product lifecycle has ended. This inherent inflexibility has become a major concern for the industry, especially given the increasing pressure to reduce costs and quicken the speed to market. To address these concerns this paper proposes a standardized design approach around an example facility solution for 2,000L-scale mAb application. The example facility focuses on demonstrating how a modular design approach may be realized using various construction methods – including traditional stick-built, prefabricated and skid assemblies, as well as modular cleanrooms or complete modular building units – without requiring major reconfiguration. At the core of this investigation is the intent to align the biopharmaceutical industry around a common understanding and approach to the design and construction of manufacturing facilities that makes the capital project process more predictable by, reducing schedule durations, improving project cost certainty, increasing facility design repeatability and ensuring greater regulatory compliance.

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