The Food and Drug Administration (FDA or Agency) just announced today the availability of a draft guidance for industry entitled “Q3D(R2)—Guideline for Elemental Impurities.
IPEC-Americas has prepared a position paper on this issue to assist MAHs in Europe in meeting their risk assessment obligations as defined in the EU Guidelines.
Third party auditing and certification of excipient suppliers can assist in the development, manufacture and supply of safe and effective medicinal products.
