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Data Integrity: A big challenge for big pharma

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Data underpins every decision in the pharmaceutical value chain – from production line optimization, through to quality control, quality assurance and batch release.

Perhaps unsurprisingly then, the completeness and reliability of pharmaceutical data has long been of interest to regulatory authorities.

But as the pharmaceutical landscape evolves to embrace collaboration with outside partners, and manufacturing and supply chains become more global and complex, regulatory authorities are putting data integrity under increased scrutiny.

Last year, the US Food & Drug Administration (FDA), the European Medicines Agency (EMA) and the Pharmaceutical Inspection Co-operation Scheme all issued new guidance aimed at enhancing data quality throughout the pharmaceutical development process, designed to ensure current good manufacturing practice (cGMP) is adhered to globally.

Many issues around poor laboratory data management relate to the way in which data is collected as well as how laboratory records are maintained. FDA guidelines state that all data associated with a pharmaceutical product should be attributable, legitimate, contemporaneous, original, and accurate (commonly known by the acronym ALCOA). Some within the industry are now calling for complete, consistent and enduring to be added that list.

Turning to technology

To improve the accuracy and consistency of data collection, the most up-to-date companies are turning to integrated informatics solutions to manage their workflows. Such technology can help take human variability out of the equation and ensure data reaches the level of reliability and completeness that pharmaceutical manufacturing demands.

Take the organization and implementation of the standard operating procedures (SOPs) associated with workflows in a chromatography lab, for example. With SOPs stored electronically in a laboratory information management system (LIMS), analysts have access to all the information required for an entire analytical workflow at the click of a button. By integrating a chromatography data system (CDS) with a built-in laboratory execution system, users can be taken step-wise through the SOP, the chromatography method parameters can be downloaded directly to the instrument and the analytical sequence initiated automatically.

Such systems can improve the consistency of data by ensuring analysts adhere to clearly defined protocols, meaning analyses are performed correctly every time. It’s a far cry from the inherently inefficient paper-based systems still used in some laboratories, which leave data vulnerable to human error and misinterpretation.

Traceability from instrument to analyst

These integrated informatics solutions are also helping laboratories ensure accountability and protect the integrity of their audit trails. As all user interactions in both the CDS and LIMS are recorded automatically and stored centrally alongside the original chromatograms and instrument calibration data, recalling this information for regulatory purposes is significantly faster and easier. More advanced LIMS such as Thermo Scientific SampleManager can integrate with individuals’ electronic laboratory notebooks and even capture non-chromatographic data from traditionally stand-alone instruments such as balances, pH meters and infra-red spectrometers, eliminating the need for original paper-based copies to be created and archived.

It’s an FDA requirement that all audit trails involving changes to critical data are reviewed for every record and before each record is ultimately approved. LIMS offering scientific data management system (SDMS) functionality allow convenient paperless review and approval procedures for these situations. They can even determine when processes are drifting towards non-conformance, giving lab managers a complete overview of and confidence in laboratory performance.

With the increased regulatory focus on data integrity, for many forward-looking pharmaceutical companies the choice is clear. When it comes to managing the data that can ultimately impact on product safety, integrated informatics is the solution.