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Article: Unrealistic risk management, vague terms plague FDA's aseptic processing paper, industry says. (Aseptic processing).
- Article from:
- Validation Times
- Article date:
- December 1, 2002
- Author:
CopyrightCOPYRIGHT 2002 Washington Information Source, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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NEW ORLEANS -- Risk management prescriptions suggested by FDA in its new aseptic processing concept paper are "unrealistic" according to industry critics speaking at the Parenteral Drug Assn's (PDA) annual meeting held here Dec. 9.
"FDA recently announced a risk-based process evaluation program," said James Akers, Ph.D., of Akers, Kennedy and Associates. "This paper does not adequately emphasize risk management. It exaggerates risk rather than proposing a scientific basis for process control and validation."
The preliminary concept paper in question, "Sterile Drug Products Produced by Aseptic Processing," was released by FDA on Sept. 27. The final ...