Coda Corp USA has compiled the following links that may be helpful to industries manufacturing under the Federal Food Drug and Cosmetic Act. Resources include, but are not limited to, US FDA Title 21 CFR, ASQ, PDA, ISPE, IVT/GAMP, ORA, etc.
If you identify a resource that you feel should be listed, please Contact Us.
FDA Offices and Divisions
- U.S. FDA Center for Drug Evaluation and Research
- Division of Manufacturing and Product Quality
- U.S. FDA Center for Biologics Evaluation and Research
- U.S. FDA Office of Regulatory Affairs
FDA Reference Room
- Guide to Inspections Oral Solutions and Suspensions
- Federal Food, Drug, and Cosmetic Act
- ORA FOIA Electronic Reading Room (Frequently Requested Documents)
- Guide to Inspections of Bulk Pharmaceutical Chemicals
- Guide to Inspections of Oral Solid Dosage Forms Pre/Post Approval Issues for Development and Validation
- Warning Letters and Responses
- Enforcement Policy: 21 CFR Part 11, Sec. 160.850; 05/13/1999, (CPG 7153.17)
- Guide to Inspections of Microbiological Pharmaceutical Quality Control Laboratories
- Federal Register
- Legal Considerations in Designing & Implementing Electronic Processes: A Guide for Federal Agencies, US Department of Justice
- Guide to Inspections of Topical Drug Products
- USSC Federal Sentencing Guidelines
- Biotechnology Inspection Guide Reference Materials and Training Aids
- Guide to Inspections of Dosage Form Drug Manufacturer's - CGMPR'S
- Public Use Forms and How to Obtain Them
- FDA/ORA Compliance Policy Guides Manual
- Managing the Risks from Medical Product Use: Creating a Risk Management Framework
- Milestones in U.S. Food and Drug Law History
- Regulatory Procedures Manual - Updated 2009
- Guide to Inspections of High Purity Water Systems
- Guide to Inspections of Sterile Drug Substance Manufacturers
- U.S.C. TITLE 18 - OCI Investigate Jurisdiction
- List of Venders Claiming 21CFR11 Compliance Services & Products Compiles by Serentec Inc for FDA, 03/06/01
- Guide to Inspections Validation of Cleaning Processes
- Dockets Management
- FDA/ORA Regulatory Procedures Manual, August 1997
United States and/or Multi-National Organizations
- American Society for Testing and Materials
- Institute of Environmental Sciences and Technology
- Association for the Advancement of Medical Instrumentation
- Active Pharmaceutical Ingredients Committee
- International Society for Pharmaceutical Engineering (ISPE)
- The Food and Drug Law Institute
- International Organization for Standardization
- American Biological Safety Association
- Institute of Electrical and Electronic Engineers
- American National Standards Institute
- National Institue of Standards and Technology (NIST)
- PDA (the Parenteral Drug Association)
- National Conference on Standards Laboratories
- American Association of Pharmaceutical Sciences
- International Federation of Pharmaceutical Manufacturers and Associations
- Institue of Validation Technology
- The US Pharmacopeia
International Organizations
- European Directorate for the Quality of Medicine
- Japan's Ministry of Health, Labour, and Welfare
- European Federation of Pharmaceutical Industries and Association
- EU National Authorities for Medicinal Products for Human Use
- Brazil's Sanitary Surveillance Agency
- Pan American Health Organization
- Association of the British Pharmaceutical Industry
- ICH Quality Guidelines and Concept Papers
- European Medicines Agency
- Icelandic Medicines Control Agency
- European Center for Pharmaceutical Medicine
- Australian Drug Evaluation Committee (ADEC)
- British Standards Institute
- Swiss Pharmaceutical Industry (Site in French and German only)
Guidance For FDA Staff and Industry
- Guidance for Industry: General Principles of Software Validation, June 1, 1997
- Guidance Documents Index
- 21 CFR Part 11; Electronic Records; Electronic Signatures Validation, August 2001
- Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance, April 1996
- Guide to Inspection of Computerized Systems in Drug Processing, February, 1983
- General Principles of Software Validation; Final Guidance for Industry and FDA Staff, 2002
- Validation of Computerized Liquid Chromatographic Systems, August 31, 1993
- Guidances and Information Sheets on Good Clinical Practice in FDA-Regulated Clinical Trials
- Glossary of Computerized System and Software Development Terminology, 8/95
- Process Validation Requirements for Drug Products and Active Pharmaceutical Ingredients Subject to Pre-Market Approval
- ORA Guide to Inspections of: Computer Issues; Updated April 2001
- Guidance for Off-the-Shelf Software Use in Medical Devices; Final 1999
- Guide To Inspections Of Pharmaceutical Quality Control Laboratories, July, 1993
- Guide to Inspections of Computerized Systems in the Food Processing Industry, Post 1997
- Proposed Regulations and Draft Guidances on Good Clinical Practice and Clinical Trials
FDA/ORA Compliance Policy Guides for Industry
- Computerized Drug Processing; Source Code for Process Control Application Programs
- Computerized Drug Processing; Input/Output Checking
- Computerized Drug Processing; CGMP Applicability to Hardware and Software
- Computerized Drug Processing; Vendor Responsibility
- Consistent Application of CGMP Determinations
- Computerized Drug Processing; Identification of "Persons" on Batch Production and Control Records
Code of Federal Regulations
- 21 CFR Part 210--Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General
- 21 CFR PART 111 Current Good Manufacturing Practice For Dietary Supplements
- 21 CFR Part 606--Current Good Manufacturing Practice for Blood and Blood Components
- 21 CFR Part 110--Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food
- Search CFR Title 21 - Food and Drugs: parts 1 - 1499
- 21 CFR Part 211--Current Good Manufacturing Practice for Finished Pharmaceuticals
- 21 CFR Part 11--Electronic Records; Electronic Signatures
- 40 CFR PART 160 Environmental Protection Agency, Good Laboratory Practice Standards
- 21 CFR Part 820--Quality System Regulation (Medical Devices)
Federal Register