New: EMEA concept paper on water

GMP-News Nr. 70

GMP-News
September 27, 2000

New: EMEA concept paper on water
 

On July 27, 2000 EMEA (European Agency for the Evaluation of Medicinal Products) published the document CPMP/QWP/1676/00 Draft and EMEA/CVMP/510/00 Draft Concept Paper on the Development of a CPMP/CVMP Note for Guidance on the Quality of Water for Pharmaceutical Use.

This concept paper formulated the target that a guideline is to be completed by January 2002 which defines when in pharmaceutical manufacturing what Ph.Eur. water quality is to be used. This is particularly important also in view of the new Ph.Eur. monograph “Highly Purified Water”. This concept paper also addresses once again the discussion about water treatment using reverse osmosis. The tables at the end of the document, which show which requirements exist for water quality for various dosage forms or individual manufacturing steps in the individual EU member states, are very helpful. You can find the document at http://www.eudra.org/humandocs/humans/QWP.htm

 

Author: Dr. G. Brendelberger, CONCEPT HEIDELBERG

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