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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 Inspection of Bulk Pharmaceuticals Chemicals, May 1994 |
| Internet: | http://www.fda.gov/ora/inspect_ref/igs/bulk.html |
| 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 are not addressed to the industry but to the inspectors of FDA. The Guides to Inspection are, however, a useful aid. You will find here guidelines for the inspection of active ingredients and excipients enterprises. Meanwhile there are more current publications of FDA for active ingredients manufacturers (1996 and 1998 as draft), and the ICH document Q7A but the guideline mentioned here also refers to excipients and is still listet as FDA document on the FDA webside. |
| Document Type: | FDA Guide to Inspection |
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