“The amount of work we performed up front was incredibly valuable.”
“We scheduled special meetings with their QA people and analytical team who would gain approval of our method, submit our data to regulatory and approve the subsequent testing. Our goal was to develop a high degree of confidence with a broad range of stakeholders, including the executives from the manufacturing side.
“In a demonstration of the data we recovered pre-test, we showed the teams”…
- All the pesticides from the USP list that we would be looking for
- A reproduction of each pesticide in a matrix highly similar to lanolin
- All the recoveries we got off our custom GPC column, as specified
After review, the client team concurred that the method is accurate, precise, linear, reproducible and suitable for intended purpose. They agreed that the change from USP standard devices to a single mass spectrometer would most likely be approved. The team presented the data to the regulators and gained approval for the optimized method.