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Exciting Updates
Stay Informed with Latest News
01
Global Regulatory Harmonization (ICH Q3E)
The International Council for Harmonisation (ICH) introduced draft guideline Q3E, standardizing requirements for assessing, screening, and controlling Extractables and Leachables (E&L) across global regulatory bodies like the FDA and EMA.
02
nforcement of Mandatory USP <665> Standards
Standardized requirements for evaluating polymeric components and single-use systems (SUS) in biopharmaceutical manufacturing are officially taking effect, making E&L testing mandatory for production-line equipment.
03
Transition to High-Resolution Mass Spectrometry (HRMS)
Regulatory agencies are expecting trace-level detection and characterization of unknown compounds using advanced LC-MS/MS and GC-MS platforms to satisfy strict Analytical Evaluation Thresholds (AET).
04
Focus on Advanced Biologics & Medical Devices
Growth in complex drug modalities, novel container-closure systems (CCS), and combined drug-device products has driven regulators to demand full lifecycle risk assessments to prevent toxicological migration into formulations.