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DATA
Light it up
Patrick Kenny Product marketing specialist, Thermo Fisher Scientific
Why the storage and access of chromatography data is vital to pharmaceutical manufacturing chains.
A
nalytical workflows underpin many of the most essential processes in the pharmaceutical manufacturing chain, from the analysis of raw materials and final products, through to method development and validation checks. These workflows often involve gas or liquid chromatography techniques, coupled to robust detection methods such as mass spectrometry, which generate large volumes of data. Organising, accessing and sharing the complex information generated by chromatography workflows can be challenging, particularly if production and quality control (QC) teams are located across multiple locations. With regulatory authorities putting increased focus on the accuracy, consistency and completeness of pharmaceutical manufacturing data, these workflows must be managed in a way that not only maximises operational efficiency and provides space to innovate, but supports full regulatory compliance too. As a consequence, many pharmaceutical organisations are re-evaluating the systems and methods they use to manage and control their chromatography data. Modern pharmaceutical manufacturing chains are highly integrated and inherently dependent upon the free flow of information between teams. To ensure the release of safe, highquality products, decision-makers need timely access to reliable and consistent QC data they can trust.
Maintaining the integrity of production line data has long been a priority for pharmaceutical manufacturers. However, regulatory bodies such as the United States Food and Drug Administration (US FDA), European Medicines Agency, and UK Medicines and Healthcare products Regulatory Agency (MHRA) are now tightening their guidance to safeguard data integrity at every stage of the pharmaceutical pipeline. This includes manufacturing, product testing and packaging steps, and all require robust solutions for managing workflow information.
parameters and calibration checks, or use separate spreadsheet software to process and report results, can be vulnerable to errors, requiring time-consuming validation and checking steps to mitigate these issues.
For organisations with production lines working across multiple territories and continents, keeping track of chromatography data while maintaining its integrity in line with regulatory guidelines isn’t always straightforward. Pharmaceutical manufacturing footprints have expanded considerably in recent years: teams may be located in different buildings, sites or even countries. While dispersed manufacturing chains can result in reduced operational costs and shorter times for products reaching end-users, they can unintentionally lead to poorly harmonised processes and inconsistencies in data.Â
Many pharmaceutical manufacturers now recognise the challenges associated with fragmented chromatography workflows and are adopting CDS software solutions that integrate their workflows to centralise the storage of data and harmonise processes company-wide.
These issues are further compounded if fragmented approaches to managing and controlling chromatography data are used. Workflows that employ partially paper-based systems to store chromatograms, method
With seamless information exchange key to achieving the highest standards of data integrity and operational efficiency, pharmaceutical manufacturers therefore need effective solutions for chromatography data management that bring their workflows, instruments and users together.Â
Among the many benefits of organising chromatography workflow information centrally, one of the most important is in terms of improved data consistency. With standard operating procedures stored centrally, modern CDS solutions allow users to download parameters and method details to instruments directly, reducing the need for manual processes, minimising the potential for human error, and ensuring the same practices are followed across the organisation. Some CDS solutions take this a step further