The Changing Regulatory Environment Concerning Elemental Impurities and Container Closure Systems
Discusses compendia addressing elemental impurities in drug packaging, and West developed techniques to assess risks in elastomeric closures.
There are new industry and compendia guidance concerning drug product and elemental impurities. A risk-based approach with a holistic understanding of sources of impurities must be taken.
Please Signup/Login to see the full article.Click here