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FDAnews Drug Daily Bulletin
Sept. 26, 2012 | Vol. 9 No. 189
Continuity, Accuracy Key to Effective Environmental Monitoring, Expert Says
Environmental monitoring programs, increasingly under scrutiny by FDA investigators, require continuous, top-level oversight and procedural accuracy to be effective, compliance experts say. While GMP regulations on environmental monitoring are written in general terms and leave it up to each company to develop its own techniques and methods, the agency expects drugmakers’ manufacturing systems to allow for continuous monitoring of temperature, humidity, pressure differentials and airflows, Kenneth Christie, chief operating officer of VTS Consultants, said.
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