USFDA Regulations
- 21 CFR Part 211 Current Good Manufacturing Practice For Finished Pharmaceuticals
- 21 CFR Part 820 Quality System Regulation (Medical Devices)
- 21 CFR Part 11 Electronic Records; Electronic Signatures
- 21 CFR Part 610 General Biological Products Standards
USFDA Guidance Documents
- Pharmaceutical cGMPs for the 21st Century – A Risk-Based Approach
- Guidance for Industry Process Validation: General Principles and Practices
- Data Integrity and Compliance With CGMP Guidance for Industry
USFDA Drug Inspections
- Compliance Guidance Program Manual – Drug Manufacturing Inspections
- CPG Sec. 130.300 FDA Access to Results of Quality Assurance Program Audits and Inspections
- Inspection Guides
USFDA Enforcement
USFDA Education
- Drugs@ FDA Glossary of Terms
- Questions and Answers on Current Good Manufacturing Practices for Drugs
- Frequently Asked Questions about the FDA Drug Approval Process
US Trade Associations
- Parenteral Drug Association (PDA)
- Regulatory Affairs Professional Society (RAPS)
- American Association of Pharmaceutical Scientists (AAPS)
- International Society of Pharmaceutical Engineers (ISPE)