Specification of Drug Substances and Products

Dr Riley is President, Riley and Rabel Consulting Services, Inc. He received a bachelor’s degree in pharmacy (1977) and PhD degree in Pharmaceutical Chemistry (1980) from the University of Bath, England. He was a post-doctoral fellow at the University of Kansas in the Department of Pharmaceutical Chemistry (1981-1982) before joining the faculty of the Department of Pharmaceutics at the University of Florida. He returned to the University of Kansas as faculty member in 1986 where he remained until 1994. He was Vice President and Head of Analytical R&D at Dupont Pharmaceuticals (previously Dupont Merck) from 1994 to 2001. He joined ALZA 2001, a subsidiary of Johnson & Johnson, where he had positions of increasing responsibility up to Vice President and West Coast Site Head ChemPharm Development. He left ALZA in May 2007 to form Riley and Rabel Consulting Services, Inc., which provides consulting services to the Pharmaceutical and Biotechnology Industries, specializing in Analytical and Pharmaceutical Development, CMC Strategy, Organizational and Managerial Effectiveness and Patent Litigation. He has co-authored more than 140 book chapters and papers in peer-reviewed journals, as well as five books. He was awarded the Conference Science Award of the Royal Pharmaceutical Society of Great Britain and the Jubilee Medal of the Chromatographic Society. He was elected Fellow of the American Association of Pharmaceutical Scientists (AAPS) and served as the chair of the Analysis and Pharmaceutical Quality Section of AAPS and a Member of the AAPS Executive Committee. Dr. Riley has served as member and chair of the PhRMA Analytical Technical Committee (ATC), as well as a member and chair of the PhRMA Technical Leadership Committee (TLC). Dr. Riley represented PhRMA on the ICH Expert Working Group on Impurities in Drug Substances (Q3A) and Drug Products (Q3B) and was Chair of the PhRMA Working Group on Genotoxic Impurities. Former Director of Business Development at Acceleration Laboratory Services, Incorporated. He has previously held scientific and senior management positions at The Upjohn Company, Marion Laboratories, Marion Merrell Dow, Hoechst Marion Roussel, Quintiles, Eli Lilly, Beckloff Associates, and PPD. He currently serves on a Small Molecule USP Expert Committee.

Part One: Basic Concepts and Definitions 1. Introduction 2. General Principles and Regulatory Considerations: Specifications 3. Application of Quality by Design (QbD) to the Development and Validation of Analytical Methods 4. General Principles and Regulatory Considerations: Method Validation

Part Two: Universal Tests 5. Description and Identification 6. Assay, and Impurities 7. Residual Solvents 8. Inorganic Impurities (Heavy Metals)

Part Three: Specific Tests: Drug Substances 9. Solid-State Characterization 10. Chiral Methods 11. Water Determination

Part Four: Specific Tests: Drug Products 12. Dissolution and Disintegration 13. Extractables and Leachables 14. Potency Assays for Biomolecules 15. Host Cell Protein Assays

Part Five: Pharmacopeial Methods 16. Pharmacopeial Methods and Tests

Part Six: Microbial Methods 17. Sterile and Non-Sterile Products

Part Seven: Biological Fluids 18. Biological Fluids