| Other Laboratory Operations 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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