Quality Digest recently featured Inorganic Ventures in the article, "Trace-Level Testing, Validation Pressure, and the New Demands on Pharma Labs," examining how pharmaceutical labs are adapting to tighter impurity thresholds and faster development timelines. (qualitydigest.com)
The article explores how sample preparation, digestion, calibration alignment, traceability, and method validation all influence whether elemental impurity data can withstand regulatory scrutiny — and why laboratories rely heavily on certified reference materials and calibration standards to establish traceable instrument response. (qualitydigest.com)
Featuring insights from Brian Alexander, PhD, president of Inorganic Ventures, the piece discusses how sample preparation, digestion, and calibration alignment can shape whether elemental impurity results hold up to regulatory scrutiny — noting that instrumentation alone can't compensate for an uncontrolled prep workflow. (qualitydigest.com)
The article also highlights how validated methods depend on consistency over the product lifecycle, and why traceability and documentation are central to pharmaceutical elemental analysis — since laboratories may need to demonstrate traceability to recognized standards and show that methods remain stable and repeatable over time during regulatory filings and inspections. (qualitydigest.com)
Read the full article here:
Trace-Level Testing, Validation Pressure, and the New Demands on Pharma Labs