This paper describes risk-based alternative strategies for defending the suitability of equipment and facilities requiring revalidation. These robust and risk-assessed approaches include real-time review, routine monitoring and in-/at-line alarms and measurements to help identify what data and testing are critical to assure the continued validated state of the equipment.
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White paper addendum to the NIIMBL-BioPhorum buffer stock blending system – a more advanced concept for buffer manufacturing
This Addendum signals the release of the design and dataset from the performance testing of the NIIMBL BioPhorum buffer stock blending (BSB) system. It is being made available as ‘open source’, which the team hopes will encourage industry adoption of the BSB System. The paper provides the team’s evaluation of the testing outcomes. It also contains information relating to the methods and approach, and the lessons learned so that others can develop and improve this technology by understanding its benefits and applications.
This template allows suppliers and customers to exchange the right information at the right time and helpa standardize this function and ensure that the ‘minimal required information’ is created and shared.
The pdf is a fully navigable high-level toolbox and guidance for R&D, technology discovery, sponsors, risk managers and regulatory teams.
Challenges encountered in the implementation of bio-fluorescent particle counting systems as a routine microbial monitoring tool
This article published in the PDA Journal of Pharmaceutical Science and Technology discusses challenges encountered when implementing bio-fluorescent particle counting systems as a routine microbial monitoring tool , and the perspective from a consortium of four industry working groups on navigating these challenges.
This document communicates a strategic framework for solving technical problems relating to managing raw materials in the biopharmaceutical industry and encourages biopharmaceutical end-users and suppliers to work together to address specific raw material and end-user process needs. It highlights the importance of implementing industry solutions and sign-posts a range BioPhorum raw materials publications. These establish standard definitions, a common understanding of raw material requirements, and the importance of regulatory, quality, and supply chain links.
This paper provides an introduction and a high-level view of on time in full (OTIF) so that when we use the acronym, we know how it is calculated and are all using it in the same way. It examines detail on the components of ‘Actual orders delivered’ and ‘Expected orders to be delivered’ and talks about the information included, actions to take and gives tips on how to best use each component.
The vacuum integrity of freeze dryers is critical for attaining adequate process control and maintaining confidence in sterility assurance which is key for the manufacture of sterile pharmaceutical products. Although discussions on the topic have been published, there is no industry standard established that is based on empirical data or that has a justifiable scientific rationale. This paper published in the Journal of Pharmaceutical Sciences provides a perspective from 14 Pharmaceutical companies on the leak rate specifications commonly used in industry. Using this information the BioPhorum team recommend a best practice for the lyophilizer leak rate test.
This paper outlines the foundational element that chart the course for pharmaceutical manufacturers who decide to take this journey and provides a vision of what that destination could look like in 10 years’ time. It outlines the current state of the industry, key challenges and barriers to adoption, and hints at the value that taking this journey will bring to patients, organizations and industry. This paper (which forms Part 1 of the Digital Technology Roadmap) looks at the problem statement and the work that has gone before.