blueski推荐 [2015/10/7]

Reminder for applicants – water mentioned on a CEP


The EDQM would like to remind holders of certificates of suitability (CEP) and their customers about the policy to be applied when water is used in the manufacturing process of a pharmaceutical substance.


When water is used in the final steps of the manufacture of a substance, this is mentioned on the CEP. By default the required quality is potable water as defined in the CPMP/CVMP Note for Guidance on quality of water for pharmaceutical use (CPMP/QWP/158/01 Revision & EMEA/CVMP/115/01 Revision).


Users are reminded that the Certification procedure does not consider the final use of a substance. Assessment is performed taking into account the general use, although in some cases further requirements with regards the quality of water are applicable, depending on the intended use of the active substance, which need to be considered in the context of the evaluation of the marketing authorisation application (MAA) for the finished medicinal product.


Only in special situations where the CEP holder claims the grade “sterile” for an active substance or the grade “to be used in parenteral preparations” (and provided it is foreseen by the Ph. Eur monograph), the quality of water will be assessed accordingly and declared on the CEP.


Therefore, for an active substance which is not sterile but is intended to be used in a sterile medicinal product, and when water is mentioned on the CEP, suitable evidence should be submitted in the MAA to confirm compliance of the water with the corresponding requirements. CEP holders should therefore provide the necessary data to their customers, for inclusion in the concerned MAA or variations.