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Pharmaceutical Manufacturing and Packing Sourcer

Replacing Paper with Productivity: Assuring Quality in Vaccine Manufacturing

PMPS: What are the benefits of using a paperless solution for quality control, and what are the benefits specifically for vaccine manufacture?

Sinéad Cowman: By their nature, paper-based workflows are prone to human and manual errors, and so removing paper from any process eliminates these issues. In addition, implementing paperless solutions optimises the workflow, providing built-in control that ensures data are collected in strict accordance with standard operating procedures. Furthermore, digitalising data capture enables real-time access to data, which can facilitate faster and better-informed decisions, as well as provide visibility into key process trends. From such visibility, quality control (QC) processes can be enhanced and expedited, which ultimately means products can be delivered to the market faster. This is true for all pharmaceutical manufacturing, including for vaccines. In the current scenario, where COVID-19 vaccine manufacturing speed is of particular importance, paperless solutions are understandably having a huge impact.

What challenges have been faced during the COVID-19 pandemic in terms of data management and digitalisation?

The ability to scale manufacturing activities – and, more importantly, to do so at speed – has been a critical challenge that many organisations have faced in response to this pandemic. Managing this on paper is inefficient and cumbersome compared with using digital solutions, and a paper-based approach has been made even more challenging by new working practices that have been implemented as a direct result of the pandemic. Working with paper means you must physically have documents in front of you to complete them, which is difficult or impossible if team members are working from home or self-isolating. Then, for review and approval of data, passing binders of documents between multiple team members is often needed. As well as being inefficient, this passing of documents presents an elevated risk of COVID-19 transmission. With an electronic solution in place, no physical document transfer is needed, and data can be accessed by anybody who needs to review them, at any location, and with greater speed.

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Sinéad Cowman, Global BD and Marketing Manager at Lonza, studied Microbiology at Trinity College Dublin, Ireland, and has over 16 years’ experience in QC Microbiology for pharma organisations. She joined Lonza in 2005 to manage their endotoxin business in Ireland, and for the past 11 years has been involved in their informatics division. Sinéad has worked with many organisations, from small biotech to global pharma companies, to implement and validate paperless solutions to enable them to achieve an automated, integrated approach to data collection and evaluation. She has a PGDip in Strategy and Innovation from Oxford University, UK, and is focused on driving the strategic direction of informatics at Lonza.
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