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EDQM Guideline Published for the Implementation of ICH Q3D on Elemental Impurities in the Certification Procedure

Certification of suitability (CEP)
04 August 2016
Strasbourg, France

A document has been prepared to provide guidance on the implementation of ICH Q3D on elemental impurities in the context of Certificates of Suitability (CEP). The document is applicable to new requests for CEPs, as well as existing CEPs.

The date of implementation is September 2016, and the EDQM guideline may be revised in the future after experience has been gained.

Any comments concerning the EDQM guideline may be submitted through the EDQM Helpdesk.

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