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Pharmaceutical Data Integrity: Are Your Controls Tough Enough?

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As pharmaceutical supply chains have grown in complexity and international outsourcing becomes the new norm, the data used by drug developers and manufacturers to make decisions on production line design, quality control and batch release is coming under greater scrutiny from regulatory authorities.

As a consequence, inspectors are increasingly on the lookout for the weak links in laboratory workflows that could put the accuracy and reliability of this data at risk.

For pharmaceutical companies, the emphasis is on ensuring that data is collected in accordance with established procedures, robust control measures are in place to prevent any kind of loss in integrity, and ultimately, official records reflect what was actually measured.

The need for traceability 

Some of the most common data integrity concerns cited by inspectors relate to the way in which laboratory information is organized and stored, with ineffective internal procedures and inadequate informatics software often to blame.

Earlier this year, the FDA issued a warning letter to an Italian manufacturer after inspectors found discrepancies between the laboratory’s official documents – showing drug products had met QC standards – and out-of-specification data in an uncontrolled spreadsheet. While the company claimed that a more experienced analyst had obtained the final set of results, this was not supported by audit trail evidence.

Incidents such as these underline the need for analytical laboratories to have robust controls in place to ensure full workflow traceability and accountability. For many pharmaceutical companies, the most effective solution will be an integrated informatics platform, comprising a chromatography data system (CDS) and laboratory information management system (LIMS).

With a CDS and LIMS managing chromatography workflows, it’s not just sequence data, method parameters and chromatograms that are securely recorded and archived, but also every user-interaction that’s made along the way.

More advanced CDS platforms, such as Thermo Scientific Chromeleon, offer powerful audit trail search functionality for all events, as well as object versioning for easy inspection of additions, deletions and modifications. This allows users to quickly recall data required for review, incorporate audit trails into reports, and conveniently demonstrate compliance with GxP. And, with lab managers able to perform targeted searches of detailed audit trails, ‘unofficial’ or unusual analysis workflows (such as sequences that involve just a few injections or those that have been aborted) can be rapidly identified and investigated.

No time like the present

Other common data integrity issues relate to not recording data at the time of measurement or not keeping original documents. In a particularly serious recent case, an Indian manufacturer was issued an FDA warning letter for destroying original copies of weight measurements once the data had been transcribed into official worksheets. Worse still, an inspector also noted one employee recording measurements in a packaging area before the product batch had even been weighed.

If records aren’t created when the data is measured, measurements are vulnerable to honest errors or even deliberate manipulation. And, while archiving original print-outs or creating official copies may be inconvenient, these documents are the evidence to demonstrate that measurements are genuine.

Because CDS and LIMS platforms securely record measurements as and when they’re made, they eliminate paper copies and leave very little room for non-compliant behavior. Modern LIMS packages such as Thermo Scientific SampleManager are able to collect data from a wide range of instruments, including balances and pH meters, with all measurements fully supported with time and date stamps as well as user identification. And, by using a LIMS with an integrated scientific data management system (SDMS), instrument data can be automatically archived and linked to results, ensuring data integrity across the laboratory.

With regulatory authorities continuing to hold the pharmaceutical industry to the highest standards of data custodianship, the most prepared laboratories are adopting integrated informatics solutions based on CDS, LIMS and SDMS as part of their wider data integrity strategies.