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FDA Sterile Drug Products Produced By Aseptic Processing - Current Good Manufacturing Practice, September 2004
Internet:http://www.gmp-compliance.org/guidemgr/files/ASEPT_PROCESS_5882FNL.PDF
Origin/Publisher:Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA
Content:These FDA guidelines reveal certain methods and procedures which must be taken account of in the aseptic manufacture of sterile medicinal products in order to comply with the CGMP requirements.
Status:final
Document Type:FDA Guidelines

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