Quality Engineering


The American Society for Quality. A world leader in quality standards and professional certifications.



The International Society of Pharmaceutical Engineers. A wealth of resources for pharmaceutical manufacturing professionals.



The Institute of Validation Technology. Resources for Validation and Compliance professionals in FDA related industries.


Six Sigma

A wealth of online resources for Six Sigma projects and impelmentation

FDA Resources

(21 CFR Part 11)

The most current information on Electronic Records and Electronic Signatures from the source of the rule.


Guidance Documents Web Page

These FDA CDERGuidance documents represent the Agency's current thinking on a particular subject.


FDA's Electronic Reading Room

Read current FDA Warning Letters and responses

FDA Regulatory Procedures Manual

The Regulatory Procedures Manual is a reference manual for FDA personnel. It provides FDA personnel with information on internal procedures to be used in processing domestic and import regulatory and enforcement matters.


International Resources


Current information from the European Medicines Agency


Ministry of Health, Labor and Welfare

Current information from the Japanese authorities


Intl. Conference on Harmonisation

Information on Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)


World Health Organization GMPs

Information on WHO Quality Assurance standards for pharmaceuticals