Root Cause Investigation

Root Cause Investigation Support

Whatever the origin is of these events, they may lead to a serious impact on quality, production process and product release. This creates a high financial impact and pressure on QA/QC teams to quickly identify the root cause of the problem. Therefore, we offer Root Cause Investigation support. With our fast turn around, we can get you quickly back on track.

Why choose Eurofins Biopharma Product Testing for Root Cause Analysis

• Access to broad scope of analytical methods (FT-IR microscopy, SEM-EDX, XRF-microscopy, NMR, LC-MS, ICP-OES/MS, XRPD)
• Quality system in place and knowledge of production under a rigorous quality environment
• Combination of expertise and capability which can ensure a fast turn around time and with a high chance of a conclusive identification

Our solution

1. An unexpected particle or foreign matter is observed during production or in a controlled environment.
2. The customer communicates to our team the circumstance of the detection and exchange information (i.e., process description, photo).
3. In a matter of hours, our team of experts will assess the issue with the impacted customer, propose a rapid plan of action and budget.
4. Samples are sent to our facility immediately after. They are tested as a priority/rush and first test results are reported as soon as available.
5. Final conclusions are drafted, and a detailed report sent to the customer. In most cases, we typically provide data back to the customer in 2 to 5 working days, so the customer can already move ahead with their internal investigation process.

Typical Case Studies

• Particle identification, particles observed on filters in upstream/downstream production or floating in injectable vials
• Aggregates, crystals, precipitate observed in buffers, fermentation, intermediates, or end products
• Foreign matter, stain, unknown powder discovered in production area or in raw material containers
• High TOC level detected in bioprocessing vessels following sterilization and cleaning
• Chemical impurities detected in Drug Substance or Drug Product (requires longer lead time if compound isolation is required prior to identification)

Why choose Eurofins BioPharma Product Testing Netherlands?

• Single point of contact. Benefit from streamlined communication through a single local point of contact while leveraging the advantages of our extensive global network.
• Complete service portfolio. Leveraging our network of GMP product testing laboratories, we can offer a comprehensive testing service portfolio to our customers.
• Standard and custom solutions. If our standard methods do not meet your needs, our skilled technicians can develop customised testing methods tailored to your specific requirements.

Read our flyer 'Root Cause Investigation' to learn more about our services. Contact us for support.