ICH Q9: Quality Risk Management (2005)
ICH Q10: Pharmaceutical Quality System (2008)
ICH M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential (2017)
WHO TR Series, No. 908, 2003, Annex 4, Good Manufacturing Practices for pharmaceutical products: main principles
WHO TR Series, No. 908, 2003, Annex 7, Application of Hazard Analysis and Critical Control Point (HACCP) methodology to pharmaceuticals
WHO TR Series, No. 908, 2003, Annex 9, Guide to good storage practices for pharmaceuticals
WHO TR Series No. 917, 2003, Annex 2, Good trade and distribution practices for pharmaceutical starting materials
WHO TR Series No. 929, 2005, WHO Guidelines for sampling of pharmaceutical products and related materials
WHO TR Series No. 937, 2006, Annex 4, Supplementary guidelines on good manufacturing practices: validation
WHO TR Series No. 937, 2006, Annex 6, A model quality assurance system for procurement agencies
EXCiPACT® Certification Standards for Pharmaceutical Excipients, 2017
WHO TR Series No. 937, 2006, Annex 7, Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability
WHO TR Series No. 885, 1999, Annex 5, Good manufacturing practices: supplementary guidelines for the manufacture of pharmaceutical excipients
WHO TR Series No. 966, 2016, Annex 5, Guidance on good data and record management practices
WHO TR Series No. 981, 2013, Annex 2, WHO guidelines on quality risk management
Aflatoxins - US FDA Miscellaneous Term
Allergens - US FDA Miscellaneous Term
Animal Sourced - US FDA Miscellaneous Term
Bioterrorism Act - US FDA Miscellaneous Term
Bovine Spongiform Encephalopathy - US FDA Miscellaneous Term
DMF US FDA DMF Guidance - US FDA Miscellaneous Term
PDA Technical Report No. 54-6 (TR 54-6) Formalized Risk Assessment for Excipients
Genetically Modified Organism (GMO) - US FDA Miscellaneous Term
Nutritional Information US FDA DMF Guidance
KOSHER
Pedigree
Responsible Care
Transmissible Spongiform Encephalopathy (TSE)
IPEC EIP
IPEC TUPP Guide
ICH Q1A(R2): Stability Testing of New Drug Substances and Products (Second Revision) (2003)
ICH Q3A(R2): Impurities in New Drug Substances (2006)
ICH Q3C(R6): Impurities: Guideline for Residual Solvents (2016)
ICH Q3D(R1): Guideline for Elemental Impurities (2019)
ICH Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances (1999)
ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (20000
ICH Q8: (R2) Pharmaceutical Development (2009)
