Specification of Drug Substances and Products

Dr. Christopher Riley is the President of Riley and Rabel Consulting Services. He received a bachelor’s degree in Pharmacy (1977) and PhD degree in Pharmaceutical Chemistry (1980) from the University of Bath, UK. He taught Pharmaceutical Chemistry, at the Universities of Florida (1983-6) and the University of Kansas (1986-94), and was a Vice President at DuPont Merck (1994-2001) and ALZA (a division of J&J) (2001-7). He has coauthored more than 140 book chapters and papers in peer-reviewed journals, as well as 5 books. He has extensive experience in CMC regulatory affairs and the development of all types of dosage forms. 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 1 INTRODUCTION 1. Introduction 2. General Principles and Regulatory Considerations: Specifications and Shelf Life Setting 3. General Principles and Regulatory Considerations: Method Development and Validation 4. Application of Quality by Design (QbD) to the Development and Validation of Analytical Methods 5. Analytical Methods in the Clinical Phase of Development 6. Method Transfer 7. Process Analytical Technology

PART 2 UNIVERSAL TESTS 8. Description and Identification 9. Assay and Impurities: Specifications 10. Assay and Impurities: Method Development and Life-Cycle Management 11. Assay and Impurities: Method Validation 12. Mutagenic Impurities 13. Residual Solvents 14. Inorganic Impurities (Elemental Impurities)

PART 3 SPECIFIC TESTS: DRUG SUBSTANCES 15. Solid State Characterization 16. Chiral Methods 17. Water Determination

PART 4 SPECIFIC TESTS DRUG PRODUCT 18. Drug Release: Oral Products 19. Topical Products 20. Extractables and Leachables

PART 5 BIOTECHNOLOGY PRODUCTS 21. Regulatory Requirements for Setting Drug Substance and Drug Product Specifications  22. Validation of Analytical Methods for Biotechnology Products

PART 6 PHARMACOPEIAL METHODS 23. Pharmacopeial Methods and Test (Updated)

PART 7 BIOLOGICAL FLUIDS 24. Biological Fluids