North America

Canadian HPFB Inspectorate
http://www.hc-sc.gc.ca/hpfb-dgpsa/inspectorate/index_e.html

Food and Drug Administration (FDA)
http://www.fda.gov

FDA CBER Guidance / Guidelines / Points to Consider
http://www.fda.gov/cber/guidelines.htm

FDA GMP Regulations (CFR21)
http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr211_01.html

FDA Human Drugs GMP notes
http://www.fda.gov/cder/dmpq/cgmpnotes.htm

FDA Inspections Operations Manual
http://www.fda.gov/ora/inspect_ref/iom/iomtc.html

FDA Inspection Guides
http://www.fda.gov/ora/inspect_ref/igs/iglist.html

FDA portal providing access to the different parts of their website
http://www.fda.gov/oc/industry/default.htm

Health Canada Compliance
http://www.hc-sc.gc.ca/dhp-mps?compli-conform/index-eng.php

Pharmaceutical and Research Manufacturers of America (PhRMA)
http://www.phrma.org

Therapeutic Products Directorate - Canada
http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt

United States Pharmacopoeia (USP)
http://www.usp.org

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