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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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| Guide to Inspections of Oral Solutions and Suspensions, August 1994 |
| Internet: | http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074935.htm |
| 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 guidelines of ORA within FDA are not addressed to the industry but to the inspectors of FDA. The Guides to Inspection are, however, a useful aid. Here you will find guidelines for the inspection of manufacturers of liquid oral preparations and suspensions. The following topics are addressed therein: premises and equipment, requirements for starting materials, manufacturing methods, microbial quality, homogeneity of suspensions, specifications, stability, packaging and process validation. |
| Document Type: | FDA Guide to Inspection |
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