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Food and Drug Administration

DOCUMENT NO.:

III-05

VERSION NO.:1.2

Section 5 - Analysts on Inspection

EFFECTIVE DATE: 10/01/2003 REVISED: 06/06/2008

5.8 Helpful References Pages on the Internet or Intranet

ORA Inspection References
http://www.fda.gov/ora/inspect_ref/default.htm

Weblern 
http://bioscilib.fda.gov/weblern/  (link to the USP, EP, JP, PDR, and other publications)

Investigations Operations Manual
http://www.fda.gov/ora/inspect_ref/iom/iomtc.html        (link to the IOM)

21 CFR Part 11
http://www.21cfrpart11.com/

CDER Guidance Page
http://www.fda.gov/cder/guidance/index.htm        (link to CDER & ICH Guidance Docs) 
http://www.fda.gov/cder/dmpq/          (link to the Preamble for 21CFR210 & 211)

CVM Guidance Page
http://www.fda.gov/cvm/guidance/guidance.html      (link to CVM Guidance Documents)
http://www.fda.gov/cvm/RuminantFeedInspections.htm  (BSE inspections)

CFSAN Guidance Page
http://www.cfsan.fda.gov/~dms/guidance.html (link to CFSAN Guidance Documents)

CBER Guidance Page 
http://www.fda.gov/cber/guidelines.htm             (link to CBER Guidance Documents)

CDRH Guidance Page
http://www.fda.gov/cdrh/guidance.html  (link to CDRH Guidance Documents)
http://www.fda.gov/cdrh/comp/gmp.html  (link to CDRH Quality Systems Documents)

CGMP Notes
http://cdernet.cder.fda.gov/dmpq/hdn/           (2001 to Current CGMP Notes)
http://www.fda.gov/cder/dmpq/cgmpnotes.htm  (1995 through 2000 CGMP Notes) 

International Conference on Harmonization (ICH) Homepage
http://www.ich.org/

Veterinary International Conference on Harmonization (VICH) Homepage
http://www.fda.gov/cvm/vich.html

http://www.fda.gov/oia/pharmgmp.html  (Lists of Documents Describing U.S. Pharmaceutical GMP Regulatory System) 

Product Code Builder
http://www.accessdata.fda.gov/scripts/ora/pcb/pcb.cfm

TurboEIR
https://oeapps.ora.fda.gov/turboeir/    (TurboEIR Webpage)

 

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