Our team recently cracked a very complex investigation where we had an unknown contaminant from the product packaging, generating out of specification results for multiple trial batches on stability for one of our key products. Significant analytical work was performed to deconvolute the source of the contaminant along with multiple conversations with the vendor to aid in the tracing of contaminant. Third party confidentiality was a significant impediment to the investigation, so analytical work was performed partially blinded, making the investigation more difficult than usual. Ultimately the contaminant was identified, its relative response factor was determined, and the accurate quantitation of impacted batches was recalculated. This enabled a safety and toxicological assessment which concluded that the unknown was within permissible limits and there is no impact or risk to patients.
Learning Objectives:
Gain insight to how to deconvolute complex investigations to get to the root cause
Better understand the finer details of blister packaging design for pharmaceuticals and how they contribute to overall stability pitfalls
See how to interpret unusual and difficult patterns in mass spectra data to identify compounds that may be blinded due to confidentiality
