Recommended Links

Click on the section to jump to those links

FDA WEBPAGES:

FDA Home Page
http://www.fda.gov

FDA Office of Regulatory Affairs for Compliance Policy Guides, Inspection Guides, Recalls
http://www.fda.gov/ora

FDA Freedom of Information for Warning Letters, Import Alerts, Investigators Operations Manual
http://www.fda.gov/foi

FDA CDER Home Page
http://www.fda.gov/cder

FDA cGMP Division of Mfg & Product Quality for cGMPs 21CFR210-211, First Party Audit Program
http://www.fda.gov/cder/dmpq

FDA Human Drug cGMP Notes
http://www.fda.gov/cder/dmpq/cgmpnotes.htm

Comprehensive List of Current FDA Guidance Documents
http://www.fda.gov/opacom/morechoices/industry/guidedc.htm

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PROFESSIONAL ORGANIZATIONS WEB PAGES:

American Society for Quality
http://www.asqc.org

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

PDA-Parenteral Drug Association
http://www.pda.org

AOAC International Home Page
http://www.aoac.org

American Chemical Society Home Page
http://www.acs.org

Nu-Genesis Website Home Page
www.21cfrpart11.com

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INTERNATIONAL WEB PAGES:

EMEA-European Agency for Evaluation of Medicinal Products
http://www.eudra.org/en_home.htm

Regulatory Affairs Information
http://www.rainfo.com

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COMPENDIAL SUBCOMMITTEE WEB PAGES:

USP Home Page
http://www.usp.org

USP Division of Standards Development
http://www.usp.org/dsd

EDQM-European Department for the Quality of Medicines (European Pharmacopoeia)
http://www.pheur.org

BP-British Pharmacopoeia
http://www.pharmacopoeia.co.uk

The Regulatory Affairs Information Home Page
http://www.rainfo.com