Regulatory Reference Page
IPEC'S REGULATORY REFERENCE GUIDANCE
Section 4-Regulatory Information Compendia/Regulations
USP/NF Food Chemical Codex EUROPEAN PHARMACOPOEIA EDQM Certificate of Suitability Chinese Pharmacopoeia
United States: Drug Master Files FDA CDER Inactive Ingredient Search
United States European Union
Residual Solvents (ICH Q3C) Residual Solvents Tables and List Kosher OU Kosher Star-K Halal ifanca-Islamic Food and Nutritional Council of America National Organic Standards Board
EMEA/ICH California Proposition 65
Kosher Certification
Muslim Consumer Group
GMP IPEC GMP Guide
ISO International Organization for Standardization IPEA International Pharmaceutical Excipients Auditing
AIB American Institute of Baking
FPA Food Products Association
IPEC GMP Guide & IPEC Audit Guide for Bulk Pharmaceuticals
HAACP
Statistical Process Control/Process Analytical Technology (PAT)
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Bio-Terrorism Act
C-TPAT
HM232
ISO 14000 ISO Standards ACC RESPONSIBLE CARE
Australia Therapeutic Goods Administration Australia Belgium - Ministry of Social Affairs, Public Health and Environmental Brazil - Ministry of Health Bulgaria - National Drug Institute Canada (Drug and Health Products) China State Food and Drug Administration Czech Republic - State Institute for Drug Control Denmark: National Board of Health Estonia - Ravimiamet State Agency of Medicines EU Agency for Evaluation of Medicinal Products European Department for the Quality of Medicines-EP Finland: National Agency for Medicines Germany - Federal Institute for Drug and Medicinal Devices Greece - National Drug Organization Hong Kong - Department of Health Hungary - National Institute of Pharmacy International Conference on Harmonization Ireland - Irish Medicines Board Italy - Direzione Generale del Ministero della Sanita Japan MHW - links to International sites Latin America - Panamerican Health Organization Latvia - State Agency of Medicines Luxembourg - Ministere de la Sante Lithuania - State Medicines Control Agency Malta - Ministry of Health The Netherlands - Medicines Evaluation Board New Zealand - Medicine Standard New Zealand Ministry of Health Pan American Health Organization Poland - Drug Institute Portugal-National Institute for Pharmaceutics and Medicinal Products Singapore - Ministry of Health Slovak Republic - State Institute for Drug Control Spain - Ministerio Sanidad y Consumo Direction Sweden - Medicinal Products Agency Taiwan-Pharmaceutical Affair Act Thailand Thailand FDA United Kingdom - Medicines Control Agency United States-Food and Drug Administration WHO
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