In the latest edition of the European Pharmaceutical Review (Volume 25, Issue 2), “How Modern Chromatography Data Systems Are Improving Regulatory Compliance In Pharmaceutical Manufacturing” looks at how pharma manufacturers are using modern regulatory requirements to ensure compliance with their chromatography data systems.
With regulatory organizations like the Food and Drug Administration (FDA) in the United States and the Medicines and Healthcare products Regulatory Agency in the UK, manufacturers are starting to look at how they can quality check and control the integrity of their information while still checking off items on the compliance list.
Pharmaceutical manufacturers need to use a data management system robust enough to meet all of the requirements of the regulating bodies while still being able to guarantee that their data is reliable and consistent. Unfortunately, many of them are using fragmented approaches to manage their chromatography data. The article discusses how Broughton Pharma pulled all of the data management processes into a single chromatography data system (CDS) and how is improved data quality and transparency through the whole collection process.
The heart of the problem
Because a CDS is typically the backbone of data management in the pharma industry, manufacturers are used to working with them to automate a wide range of services. These CDSs are not being fully utilized, with employees using the system from some things while still relying on the old methods that were once in place, such as paper-based storage, spreadsheets and so on. This causes a disjointed approach to data management. Add to that the fact that most CDSs were designed for research labs and you’ll find that a regulated pharmaceutical manufacturer typically doesn’t have the digital architecture to of functionality to facilitate compliance.
Loss of consistency and reliability is a result of a fragmented system as is the inability to standardize processes. Transparent accountability is also lost, and this can cause issues when it comes time to be audited and present all of the information required.
Modern CDS management can bring everything together
Broughton upgraded their old CDS in order to simplify the way they managed chromatography workflow data. This helped with the company’s growth and the challenges that came with coordinating workflows and instruments. They found a CDS solution that worked with all of the laboratories’ existing instruments, which were supplied by a wide range of manufacturers.
The new systems helped them achieve a high level of data consistency in their routing analysis thanks to the use of downloadable templates. These templates, when used alongside other productivity tools, allowed Broughton to streamline operations. It also helped the company demonstrate regulatory compliance more efficiently while reducing the administrative burden of both FDA and MHRA audits.
For more information on how Broughton successfully utilized a CDS system to manage their data, read the full European Pharmaceutical Review article at: https://www.europeanpharmaceuticalreview.com/article/117127/european-pharmaceutical-review-issue-2-2020/.