Patrick Kenny, product marketing specialist for Thermo Fisher Scientific explains why the storage and access of chromatography data is vital to pharmaceutical manufacturing chains.
Chromatography data
Analytical 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, high-quality 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.
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.
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 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.
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.
Many pharmaceutical manufacturers now recognise the challenges associated with fragmented chromatography workflows and are adopting chromatography data system (CDS) software solutions that integrate their workflows to centralise the storage of data and harmonise processes company-wide.
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 and incorporate sophisticated algorithms that can perform user-defined tasks such as dilutions or reinjections to obtain high-quality chromatograms first time around. Advanced systems, such as Thermo Scientific Chromeleon CDS Software, can even automate the integration of chromatogram peaks, further enhancing the consistency and reliability of data.
Storing chromatography information centrally can also help teams work more efficiently by maintaining a single version of the data, eliminating the inconsistencies that can be introduced if multiple versions of files are used. CDS solutions that facilitate centralised storage also allow data to be securely accessed by colleagues wherever they are, allowing them, for instance, to initiate and check on sequences remotely. With easy access to the latest chromatography data at the click of a button, results can be shared faster, helping teams make decisions around manufacturing and batch release more quickly and, ultimately, accelerating the delivery of therapeutics.
The increased complexity and footprint of modern pharmaceutical manufacturing processes means regulators are putting an increased focus on the traceability and transparency of the data associated with chromatography workflows. Regulations such as U.S. FDA Title 21 CFR Part 11 and UK MHRA ‘GXP’ Data Integrity Guidance and Definitions require pharmaceutical manufacturers to ensure traceability from measurement to reporting. For large organisations with multiple moving parts, maintaining full accountability across the manufacturing chain can be challenging; demonstrating compliance in the event of an audit even more so.
The latest CDS software solutions make it straightforward for pharmaceutical manufacturers to achieve end-to-end oversight of chromatography workflows and avoid the complexities associated with harmonising audit trail information when fragmented solutions are used. Most CDS solutions will store a complete history of interactions with the system. However, some of the more advanced CDS solutions offer powerful audit trail functionality to enable users to quickly and easily search and review events in order to help detect unusual or non-compliant user behaviour. Some platforms, like Chromeleon CDS, allow all events to be easily key-word searched and filtered based on action, and even allow audit trails to be added to reports for review. With the right tools to support complete workflow transparency right across the manufacturing chain, businesses can reduce time searching and focus more on innovation.
Chromatography workflows play a central role in pharmaceutical production processes and manufacturers need effective solutions that make managing, accessing and sharing this information between teams seamless, secure and regulatory-compliant. The latest CDS software solutions are helping to maintain the highest standards of data integrity to help the pharmaceutical industry accelerate the manufacture of safe and effective medicines for patients.