Regulatory References

This page provides links, for example, to documents, lists, policies, programs, and statements relating to regulatory references used by various government organizations.

FDA

U.S. Food and Drug Administration (FDA) web site:  http://www.fda.gov

• Food and Drug Administration Organizations and Mailing Address
  
  
• Center for Drug Evaluation and Research List of NEW Guidance Documents:
  http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm121568.htm
  
  
• FDA Compliance References used by FDA personnel: 
  www.fda.gov/ora/compliance_ref/part11/FRs/background/pt11finr.pdf
  
  
• FDA Pharmaceutical cGMPS for the 21st Century - A Risk-Based Approach: Second Progress Report & Implementation Plan
  
  
• Guidance for Industry on Part 11, Electronic Records, Electronic Signatures – Scope and Application, 2003
  
  
• CFR 21 Part 11 Warning Letters
  
  
• General Principles of Software Validation; Final Guidance for Industry and FDA Staff, 2002
  
  
• Guidance for Industry: Computerized Systems Used in Clinical Trials, 1999
  
  
• A Risk-Based Approach to Pharmaceutical Current Good Manufacturing Practices (cGMP) for the 21st Century:A Progress Report
  
  
• Electronic Submissions (CDER):
  http://www.fda.gov/cder/regulatory/ersr/default.htm
  
  
• Guidance for Industry: Providing Regulatory Submissions in Electronic Format – General Considerations, October 2003
  
  
• Providing Regulatory Submissions in Electronic Format — Content of Labeling; Draft Guidance, 2004
  
  
• Electronic Common Technical Document (eCTD):
  http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM129624.pdf
  
  
• ICH Guidance Documents: 
  http://www.fda.gov/RegulatoryInformation/Guidances/ucm122049.htm
  
  
• ICH Guideline for Good Clinical Practice:
  www.ich.org/MediaServer.jser?@_ID=482&@_MODE=GLB

Other Regulations & Standards

• The Rules Governing Medicinal Products in the European Union: 
  http://ec.europa.eu/enterprise/sectors/pharmaceuticals/documents/eudralex/index_en.htm
  
  
• Good Practices for Computerized Systems in Regulated “GXP” Environments, PIC/S Guidance, 2003:
   http://www.gmp-compliance.org/eca_guideline_1438.html
  
  
• Health Insurance Portability and Accountability Act of 1996:
  http://www.hhs.gov/ocr/hipaa
  
  
• Sarbanes-Oxley Act of 2002: http//www.sarbanes-oxley-forum.com
  
  
• COSO framework: www.coso.org
  
  
• NIST Special Publication SP800-30: Risk Management Guide for Information Technology Systems, 2002
  
  
• ISO 14971:2000 – Medical devices - Application of risk management to medical devices, 2000: http://www.iso.org
  
  
• NIST Special Publication SP 800-53A: Guide for Assessing the Security Controls in Federal Information Systems Building Effective Security Assessment Plans
  
  
• ISO/IEC 17799:2000 (BS 7799:2000) Information Technology –
  Code of practice for information security management (ISO/IEC, 2000): http://www.ansi.org
  
  
• The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems,
  GAMP 4 (ISPE/GAMP Forum, 2001) requires registration and login:     www.ispe.org/gamp
  
  
• Department of Defense Best Practices for Data Quality Oversight of Environmental Sampling and Testing Activities – Improving Laboratory Oversight
  
  
• EPA Directive 2185: Good Automated Laboratory Practices:
  http://www.epa.gov/irmpoli8/irm_galp
  
  
• No. 10 in OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring:
  The Application of the Principles of GLP to Computerised Systems, 1995
  
  
• Legal Considerations in Designing and Implementing Electronic Processes: A Guide for Federal Agencies, U.S. Department of Justice, 2000.
  
  
• Records Management Guidance for Agencies Implementing Electronic Signature Technologies, National Archives and Records Administration, 2000. http://www.archives.gov/records_management/pdf/electronic_signiture_technology.pdf
  
  
• IVT Network Infrastructure Qualification Proposed Standard:
  http://www.gxpandjvt.com/IVTNews/pdf/committee.pdf

Other Resources

• Society of Quality Assurance: www.sqa.org/
  
  
• Part 11 forum: http://tech.groups.yahoo.com/group/21cfrpart11
  
  
• San Diego Regulatory Affairs Network: www.sdran.org
  
  
• Orange County Regulatory Affairs Discussion Group: www.ocra-dg.org
  
  
• Reference for GLP systems: www.labcompliance.com