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FDA Guidance for Industry: Sterile Drug Products Produced By Aseptic Processing - Current Good Manufacturing Practice, September 2004


Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA,

Document Type:
FDA Guidelines
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.

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