Container closure systems

Container closure systems

Elemental Impurity Risk Assessment vs Confirmatory ICP-MS Testing: When Do You Need Both?

Elemental Impurity Risk Assessment vs Confirmatory ICP-MS Testing: When Do You Need Both?

Elemental impurities remain a critical consideration in pharmaceutical quality systems because trace metal contaminants can affect product safety, regulatory compliance, and overall product quality. To manage these risks, pharmaceutical manufacturers are expected to follow the principles outlined in ICH Q3D, which provides a risk-based framework for evaluating and controlling elemental impurities. However, one of the […]
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Nitrosamine Risk in Packaging and Storage: The Overlooked Source After Manufacturing

Nitrosamine Risk in Packaging and Storage: The Overlooked Source After Manufacturing

Nitrosamine impurities have become one of the most closely scrutinized classes of pharmaceutical contaminants due to their potential carcinogenic risk and increasing regulatory attention. Following several high-profile product recalls, pharmaceutical manufacturers have implemented extensive risk assessment and testing programs to identify and control potential sources of nitrosamine formation. Most discussions surrounding nitrosamines focus on manufacturing […]
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