From: Michael.Gross@aventis.com Sent: Monday, November 03, 2003 12:24 PM To: fdadockets@oc.fda.gov Subject: Docket No. 2003D-0382: comments submitted electronically; hard co py to follow by mail <<...OLE_Obj...>> <<...OLE_Obj...>> November 3, 2003 Division of Dockets Management (HFA-305) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane; Room 1061 Rockville, MD 20857. Docket No. 2003D-0382 Re: Draft Guidance for Industry on ``Sterile Drug Products Produced by Aseptic Processing'' To Whom It May Concern: Aventis Behring is pleased to provide comments on FDA's recently issued draft guidance entitled, "Sterile Drug Products Produced by Aseptic Processing,'' which was announced in the Federal Register, Volume 68, Number 172, page 52782-52783, on September 5, 2003. Aventis Behring is a manufacturer of plasma derived protein therapeutic products with manufacturing operations in the United States and Europe. The information provided herein represents a consensus of comments provided by these manufacturing sites and our corporate quality assurance department. The enclosed table contains 94 comments and/or suggestions for alternative wording of portions of the guidance text. We hope that you find our comments useful. We appreciate the opportunity to provide feedback to FDA on this important guidance document and we wish to provide encouragement to FDA on its drug quality initiative. Sincerely, Michael Gross Vice President, Worldwide Compliance <>