Elemental Impurities FAQs

This FAQs section details frequently asked questions about the Elemental Impurities database.

List of available Elemental Impurities FAQs

How is the blinding process managed by Lhasa?

If a company participates in the data sharing, does Lhasa dictate which excipients to test, how many batches, and how many excipients to test?

If we are doing risk assessment on final drug product, is it required to obtain elemental impurities data on API and excipient?

Is the database approved and accessible by regulators? Will they refer to it when reviewing my DP risk assessment?

Is this database accepted by a European Authority of pharmaceutical products?

Manuf. location/country of origin is an important factor to this data, is it required to be included when data is submitted to the database?

What if the elemental impurities data in the database for a specific excipient changes after I’ve completed my DP risk assessment?

What is the risk that only excipients with low levels of elemental impurities data are submitted to the Lhasa database?

What is the typical cost to access the database?

Who can access the database?

Why is the data blinded for suppliers?

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