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USP Proposes Risk-Based Metal Impurity Limits for Drug Products, Components

This article was originally published in The Gold Sheet

Executive Summary

USP applies risk-based approach to heavy metals, AKA elemental impurities.

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Pharma Gets More Time to Control Elemental Impurities

Delays in application of new USP and ICH limits on lead, mercury and other elemental impurities give industry more time to do the risk analysis and prepare to use new ICP-AES and ICP-MS test methods. The old heavy metals method was fine for yesterday’s lead-tainted water supply issues; the new methods are better for today’s global supply chain concerns.

As ICH Q3D Metal Impurity Limits Near, Industry Worries What New Tests May Find

With ICH planning to propose Q3D metal impurity limits in June and USP requiring new metals test methods soon thereafter, pharmaceutical companies are wondering whether any of their ingredients might fail the tests, perhaps requiring them to reformulate products or suspend production. Early indications from FDA and industry testing are largely reassuring, while highlighting some areas for further inquiry.

USP Tightens Supply Chain Controls with Risk-Based Vendor Qualification

USP biologics supply chain standards focusing on vendor qualification, not just testing - and a risk-based approach to both. Ancillary materials chapter four years ago set new ground rules with four risk tiers, now being applied in specific chapters for vaccines, Protein A, cytokines and more. Life Technologies' global sourcing and risk mitigation strategies explained. How BD Biosciences qualifies vendors. Building culture media relationships. Third revision of heparin monograph under way as USP seeks to further tighten controls against economically motivated adulteration.

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