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Applying the power of human performance to documentation for successful outcomes

This paper outlines the application of human performance principles to document design and provides guidance for how to implement this in a biopharmaceutical manufacturing environment, with proven results. A more effective system for creating and revising documents—specifically, one that is
aligned with human performance principles—leads to reduced time spent revising documents, improved training and performance, and fewer deviations and CAPAs. By investing the time to understand how work is done and creating documents that align with the needs of the end-user and the realities of how work is performed, we can harness the reliability and promise of a learning organization that is steeped in the principles of human performance.

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A risk-based approach to second person verification in microbial testing

Ensuring the integrity of microbiological test data is fundamental to drug product quality and patient safety. The FDA is particularly focused on the data integrity of microbial tests as these often use manual methods that could be open to error or fraud. At present, the soundness of traditional culture-based microbiological test data is largely determined by factors such as effective sampling, valid testing and the interpretation of results. A...

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Continued process verification (CPV) and the validation of informatics systems

Continued process verification (CPV) provides ongoing verification of the performance of a manufacturing process and as such entails the processing of large amounts of data. This paper draws on the experiences of multiple biopharmaceutical manufacturing companies in validating the informatics components of their CPV programs. It sheds light on common issues and provides recommendations and best practices. Computer systems validation is relevant across the lifecycle of a CPV informatics solution. As such the papers scope includes the initial and ongoing activities and deliverables to determine that the solution meets its intended uses and other requirements, for example, data integrity and performance requirements. 

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Human performance (HuP): Guide to implementing and maintaining a leader observation and coaching program

A well established Human Performance program will significantly reduce failures and deviations in any biomanufacturer’s operation. Critical to this is the creation of a culture where leaders partner with workers to learn about what enables success and what creates challenges. This learning is most effectively done through first-hand observation, active listening and ensuring candid discussions about systems’ issues related to risk. Written by BioPhorum’s Human Performance Workstream, this guide details how to implement and maintain a leader observation and coaching program, what such a program entails, the expected benefits, the expectations for leaders and a suggested implementation plan.

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Human performance (HuP): A new measurement approach to better drive, safety, quality, reliability in biopharmaceuticals

One of the dilemmas companies face when driving down failures and near misses to ‘zero’ is what to measure. Conventional approaches often fail to support ambitious ‘zero’ performance levels and can discourage the right type of debates and discussions. This guide from the Human Performance (HuP) team explains how biopharma operations can understand and measure performance in the most meaningful way and how to capture risks and enable sustainable learning and improvement through the ‘Family II’ mindset. Piloted by four companies the guide explains how to measure success rates and encourage employee reporting, how to implement such reports, and management the communication around the program to help everyone get closer to the target of zero failures.

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Product changeovers (PCO): Justification for minimizing the removal of elastomers to prevent cross contamination in a multi-product facility

The primary objective of any biopharmaceutical product changeover (PCO) program is to employ control strategies before, during, and after the manufacturing process which will minimize the opportunity for cross- contamination when switching between products. Evaluation of the need for an elastomer change out (ECO) should be considered as a segment of an overall changeover assessment. By understanding the actual value of ECO in terms of the overall PCO program, and the other systems and procedures that are in place that protect against cross contamination, the need for ECO for every product changeover is not necessary. The purpose of this paper is to review the practice of ECO at product changeover, evaluate the need for an ECO using a risk based approach, and provide rationale for justifying the reduction or elimination of ECO at product changeover.  Based on the experience in six companies and the use of elastomers in over 10 manufacturing sites. It outlines that using a risk-based approach to outline the rationale for reducing elastomer change-out at the biopharmaceutical change over.

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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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Continued process verification (CPV) of legacy products in the biopharmaceutical industry

This guide to the implementation of continued process verification (CPV) across a portfolio of legacy products complements the foundational document ‘Continued process verification (CPV): An industry position paper with an example plan’ published in 2014. The guide helps biomanufacturers understand how to build efficient and effective plans for legacy products and links to QA systems, provides guidance on implementations across multiple sites and advises on discovery, disclosure and regulatory reporting.

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Human performance (HuP): Training for biotech manufacturing operator competence

For decades, the biopharmaceutical industry has trained its workforce with a ‘read and understand’ approach. This approach is outdated and ineffective at delivering effective learning and competent staff. This ‘Training for competence’ guidance enables companies to understand how their organisation compares to their peers, and to identify what ‘best in class’ looks like for operator training, and will help to identify how to implement this approach across their networks

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Human performance (HuP): Changing the performance paradigm in pharma/biotech: Integrating human performance in global organizations

In 2015 when the BioPhorum Human Performance team started to understand how the industry could reduce error rates many were seeing a plateau of performance. Industry data showed 50% of deviations were attributable to human error and that the error rate has been constant over several years. Comparing us to other high-risk industries with unparalleled levels of reliability, such as nuclear power and aviation, the team saw that changes that could be made with the integration of HuP into our operations.

This article utilizes the experience of two large, global biotech companies, at the time to illustrate the pathways to integrate HuP and the benefits realized not just in human error reduction, but also to quality, safety, compliance, and on-time delivery—the critical measures that will make or break a biotech company’s performance.

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