The following links relating to the U.S. Food and Drug Administration (FDA) may be of interest to readers.
FDA Home Page: http://www.fda.gov/default.htm
FDA GMP Regulations (CFR21): http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr211_ 01.html
FDA Inspections Operation Manual: http://www.fda.gov/ICECI/Inspections/IOM/default.htm
FDA Inspection Guides: http://www.fda.gov/ora/inspect_ref/igs/iglist.html
FDA CBER Guidance / Guidelines / Points to Consider: http://www.fda.gov/cber/guidelines.htm
FDA Guidance on Drugs: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInfor mation/Guidances/default.htm
Posted by Dr. Tim Sandle,
Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)
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Pharmaceutical Microbiology Resources