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COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS …

Note For guidance on Quality of Water for Pharmaceutical Use GE022a gggmmmpppeeeyyyeee 1 2002 5 CPMP/QWP/158/01 Revision EMEA/CVMP/115/01 Revision COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS (CVMP) (NOTE FOR guidance ON QUALITY OF WATER FOR PHARMACEUTICAL USE) Discussion in the Quality Working Party October 2000, January 2001 Transmission to the CPMP/CVMP February 2001 Release for Consultation February 2001 Deadline for Comments August 2001 Discussion in the Quality Working Party October 2001 Transmission to CPMP/CVMP November 2001 Adoption by CPMP/CVMP November 2001 Discussion in QWP Following Industry Representation Modification to Tables 3 and 5 April 2002 Adoption by CPMP/CVMP May 2002 Date for Coming into Operation 1 June 2002 Changes are in.

Note For Guidance on Quality of Water for Pharmaceutical Use GE022A ggmmppeeyyee www.gmpeye.co.kr 6 bacterial endotoxins (not more than (nmt) 0.25 IU of endotoxin per ml),

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