BioCentury
ARTICLE | Clinical News

Dianeal regulatory update

October 3, 2011 7:00 AM UTC

EMA's CHMP completed its review of the manufacturing of Dianeal, Extraneal and Nutrineal peritoneal dialysis solutions at Baxter's Castlebar, Ireland, manufacturing plant and concluded that the undetected cracks in equipment allowed the growth of endotoxin-producing bacteria while the design and cleaning methods of the plant led to further contamination. CHMP said the plant will undergo improvements, including a redesign of the plant, new cleaning regimens and introduction of improved testing methods. CHMP said the plant will be inspected in October and go through a year long requalification period, under which the plant will carefully monitored and the products will undergo "rigorous testing" and increased surveillance. ...