Driving quality and efficiency: The role of chromatography data systems in pharma CDMOs
24th Jan 2025
Chromatographic analysis accounts for a large proportion of the analytical testing in pharmaceutical drug development and manufacturing quality control. This includes testing from instruments such as high-performance liquid chromatography (HPLC), gas chromatography (GC) and ion chromatography (IC). A Chromatography Data System (CDS) controls chromatographic instruments, collects data and is used to process, report and archive the results. Through the application of a cGMP and FDA 21 CFR Part 11 compliant CDS, CDMOs can generate accurate data that adheres to quality standards and can be used to manufacture a product that is safe and effective for its customers and their patients.
Here, we explore the role and the benefits that customers will see from their chosen CDMO’s use of an appropriate CDS:
A CDS offers the ability to automate aspects of data collection and data management. An increase in automation reduces the requirement to manually manage data; promoting an effective way to minimise the risk of human error. Automation can also reduce the number of steps needed to perform the analysis enabling faster and more efficient generation of results.
Customers see the benefits of increased accuracy through reliable results and reductions in analytical deviations as well as faster turnaround times of analysis. With access to reliable data, CDMO’s and their customers are placed in a better position to make informed decisions about the development and manufacturing process of their products.
CDS software is a key tool for ensuring regulatory compliance in an analytical cGMP environment. A compliant CDS employs customisable controls to report accurate and transparent data that CDMO’s and their customers can trust to ensure the safety of the final product.
Controlling a CDS requires continual adaptation to changeable regulations and shifting organisational dynamics. It must also adhere to the data integrity principles outlined by ALCOA++. This includes attributable user accounts for every user to ensure full accountability, all data records to be complete, consistent, and available for the appropriate time range. Additionally, for full traceability, all changes can be logged in an audit trail so that a full narrative of events is accessible. This level of transparency is essential to achieve regulatory compliance and it is also critical for building a trusting relationship between CDMO and the customer.
A CDS offers many options for continuous improvement either through periodic updates to software from the software developers or through productive use of customisable software features from the user.
Routine self-inspection is key to ensuring that control of a system is maintained over time and that processes develop and evolve with new guidance and technology. Through self-analysis it is possible to identify opportunities for improvement; leading to constructive outcomes that can support better decision making for businesses and their customers.
How Sterling Utilises its CDS
Sterling has developed a comprehensive set of procedures based around its CDS, which not only ensure compliance and adhere to the ALCOA++ principles but also increase accuracy and productivity. ... Read more
Customers benefit from the assurance that all calculations are created accurately and are verified in exact accordance with the analytical method and specification. All calculations are reviewed by a second person and once approved, the templates are locked to prevent further unauthorised alteration. As a control measure, the permission to edit master methods and eWorkflows is limited to designated users. These procedures ensure that only correct and relevant data is reported to our customers.
Sterling employs a combination of preventative checks prior to analysis and full review post-analysis as an effective approach to controlling unnecessary deviations. This involves a complete review of the analysis that includes instrument and processing parameters as well as reporting calculations and audit trail review. These checks proactively minimise errors while the traceability features of the audit trail, provide full accountability and can be checked in the review process to ensure that each analysis has followed procedure. This form of risk management minimises the likelihood of incorrectly input data and when coupled with the use of automated workflows, effectively controls the risk of errors. This level of control is a practical route towards ‘right first time’ goals and assures customers of the strict processes we follow to produce accurate data.Read less
Sterling’s Continuous Improvement
Sterling’s cGMP compliance and commitment towards continuous improvement are demonstrated through CDS controls that include regular self-inspection and monitoring of key performance indicators (KPI). ... Read more
Each month data is randomly selected and thoroughly investigated by a trained CDS administrator. The analysis in the CDS is fully reviewed from start to finish to confirm that it adheres to the testing monograph and Sterling’s standard operating procedures (SOPs). Tools in the CDS such as the query function, that allow the search for duplicate runs of the same sample, and audit trails, that can be reviewed to build up a comprehensive picture of analysis from start to finish, are essential to performing a thorough review. Any findings are discussed between stakeholders and can be captured to prevent reoccurrence of the issue. Data audits lead to constructive outcomes including updates to testing monographs, identification of training requirements and the reinforcement of good practice. As well as being a standard expectation from auditors, data audits demonstrate Sterling’s efforts towards continual improvement and customers benefit from the constructive conclusions drawn from the audits.
Another self-inspection that Sterling performs is tracking the use of manual and automatic integration. Automatic integration is a tool that the CDS facilitates and can be applied across all injections of a sequence to produce correct and consistent integration throughout. The control that it provides is critical to reducing bias and delivering an accurate result quickly and effectively. Despite the benefits of automatic integration, there is sometimes a necessity to perform manual adjustments to integration to generate a true result. To ensure correct use of manual integration, Sterling monitors and controls its levels through routine self-inspection as a KPI. The sitewide KPI for manual integration is generated monthly to calculate the exact number of injections within the GMP data vault where at least one instance of manual integration has occurred. If the nominal limit is reached in that month, an investigation is launched to identify a cause. Investigating instances of analysis with high levels of manual integration leads to a clearer understanding of the method requirements that result in improved processing parameters. Guidance for integration in any subsequent analysis can be updated in the analytical method to improve integration consistency and reduce processing time. Improved understanding of a method supports better decision making concerning the analysis and details can be passed on to customers to supplement their understanding of the product. Read less
Global Deployment of the CDS
An additional benefit that Sterling has realised from the implementation of a CDS, is its ability to successfully support company growth and global, cross-site standardisation.
Sterling has acquired multiple new sites since 2019 and the ‘One Sterling’ vision aims for all customers and employees to receive the same exceptional experience independent of the site. Due to the importance of chromatography in analytical development and quality control, harmonisation of the CDS has been an important focus for the Sterling network. ... Read more
Emphasis on deploying the most recent version of the CDS to each site has been critical to ensure that all system users have up to date and equivalent software. CDS users at every location receive comparable, comprehensive training resulting in a high-level of understanding of the software. This understanding has led to constructive collaboration of ideas and developed an expanded global knowledge pool at Sterling, resulting in the continuous improvement of the system.
Sterling’s CDS controls have been implemented consistently between sites. Use of verified report templates and eWorkflows mean that CDS users have a familiarity with set-up, processing, and reporting of data and importantly, customers have a consistent experience of analytical reports across projects and sites. A further advantage to customers is that if they manufacture their product at any other Sterling site, their analytical workflows and methods can be transferred, ensuring comparable analysis, reporting and time saving.
Chromatography Data Systems are designed to be effectively managed, and Sterling have utilised functionality by developing an extensive set of controls to maintain compliance and operational excellence. A reduction in repeated adverse findings in data audits as well as routine monitoring of the KPIs for manual integration and electronic signatures indicates that our controls are having a positive effect on the system. With operative automated procedures in place and controls that facilitate adherence to regulatory compliance, Sterling effectively utilises its CDS to drive both quality and efficiency.Read less