Regulatory References

General Regulatory Links

United States

• Questions about the UNII
• Corrections and questions about the IID
• DMF: The Common Technical Document
• FDA CDER Inactive Ingredient Search (IID)
• FDA Inspection Classification Database
• FDA's Guidance for Industry: Testing of Glycerin for Diethylene Glycol
• Food and Drug Administration Safety and Innovation Act (FDASIA)
• Generic Drug User Fee Amendments of 2012
• Generic Drugs: Information for Industry (IPEC-FDA meeting minutes and relevant IID information
• GRAS
• Guidance for Industry Non-Clinical Studies for the Safety Evaluation of Pharmaceutical Excipients
• Guidance, Compliance, & Regulatory Information
• Questions about excipients in development of generic products: Controlled Correspondence
• UNII
• United States: Drug Master Files
• US Rule making gateway

Europe

• EU Falsified Medicines Directive, EMEA Q&A
• EMA Guidelines for Excipients

Product Regulatory Data Sheet
Regulatory Information Compendia/Regulations

Compendia/Regulations

• British Pharmacopoeia
• Chinese Pharmacopoeia
• EDQM Certificate of Suitability
• EU EudraLex
• European Pharmacopoeia
• Food Chemical Codex
• Japanese Pharmacopoeia 16
• Japanese Pharmacopoeia JPE
• The International Pharmacopoeia
• US 21CFR
• USP/NF

Regulatory Information - BSE/TSE

• China
• European Union
• Japan
• United States

Allergens

• European Union
• Japan
• United States

Regulatory information – GMOs

• China (English version of the Ministry Of Health site is under construction)
• European Union
• Japan
• United States

Miscellaneous

• EMEA:
  • Impurities - Harmonisation of Potentially Genotoxic Impurities, Heavy metal Catalysts Residues and Class 1 Solvents Residues
• Elemental Impurities, ICH Q3D:
  • ICH Q3D Guideline
  • US FDA
  • EU EMA
• Halal:
  • IFANCA-Islamic Food and Nutritional Council of America
  • Muslim Consumer Group
• Kosher:
  • Kosher Certification
  • OU Kosher
  • Star-K
• Other:
  • National Organic Standards Board
  • California Proposition 65
• Residual Solvents - ICH Q3C:
  • ICH Guidelines
  • US FDA Version
  • US FDA Version Tables and List
  • EMEA Version
  • ICH Guidance Documents

Site Quality Overview

IPEC Excipient GMP Related Guidance Documents (Guides are available in the Document Depot, inside the Reference Center)

Compliance evidence:

• AIB American Institute of Baking
• GMA Grocery Manufacturers Association
• Pharmaceutical Excipients Auditing
  • ​NSF International
  • EXCiPACT
• ISO International Organization for Standardization

IPEC GMP compliance details

• IPEC-PQG GMP Audit Guide for Pharmaceutical Excipients (this guide is available in the Document Depot, inside the Reference Center)

Miscellaneous site information

• HACCP - Hazard Analysis & Critical Control Points
• Statistical Process Control/Process Analytical Technology (PAT) – Guidance
• Statistical Process Control/Process Analytical Technology (PAT) – Initiative

Site and Supply Chain Security Overview 

Site and supply chain security

• Bio-Terrorism Act
• CFATS Chemical Facility Anti-Terrorism Standards
• C-TPAT (Customs - Trade Partnership Against Terrorism) 
• Rx-360

Security information

• Hazardous Materials

Safety and environmental information

• ACC Responsible Care
• ISO 14000
• ISO Standards