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The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
In cases in which you can order through the Internet we have established a hyperlink.
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| Sterile Drug Products Produced By Aseptic Processing - Current Good Manufacturing Practice, September 2004 |
| Internet: | http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070342.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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