Elemental Impurities FAQs
This FAQs section details frequently asked questions about the Elemental Impurities database.
Is the database approved and accessible by regulators? Will they refer to it when reviewing my DP risk assessment?
The elemental impurities consortium’s vision is to have the data accessible to industry and regulators. Six regulatory bodies have been introduced to the database and the consortium is keen to continue regulatory engagement. One regulator and two pharmacopeias have access to and are using the database.
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