Specification of Drug Substances and Products

SECTION 1: INTRODUCTION 1. Introduction SECTION 2: REGULATORY CONSIDERATIONS AND STATISTICAL APPROACHES 2. General Principles and Regulatory Considerations: Specifications and Shelf-Life Setting 3. Specifications and Expiry Dates based on Accelerated Stability Studies 4. Analytical Procedure Life Cycle Management 5. Analytical Target Profiles for Quality Attributes 6. Process Analytical Technology 7. Pharmacopeial Methods and Tests ER 8. USP Monographs 9. British Pharmacopoeia 10. Submission, Review and Approval of Specifications and Analytical Procedures: Pre-Clinical and Clinical Phases 11. Submission, Review and Approval of Specifications and Analytical Procedures: Marketing Authorization Applications 12. Special Regional Requirements: ASEAN, ANVISA and WHO SECTION 3: Critical Quality Attributes 13. Description and Identification 14. Assay and Impurities: Specifications 15. Assay and Impurities: Method Development as Part of Analytical Life Cycle Management 16. Assay and Impurities: Validation 17. Mutagenic Impurities 18. Residual Solvents 19. Elemental and Inorganic Impurities 20. Extractables and Leachables 21. Microbiological Testing 22. Solid-State Characterization 23. Chiral Methods 24. Water Determination SECTION 4: DOSAGE FORMS AND PRODUCT TYPES 25. Orally Administered Dosage Forms 26. Topical Products 27. Transdermal Products 28. Inhalation Products and Nasal Sprays 29. Ophthalmic Products 30. General Parenteral Products 31. Specification of Biotechnology Products 32. Biotechnology Products 33. Antibodies and Antibody-Drug Conjugates 34. Oligonucleotides and m-RNA and DNA Delivery Systems 35. Liposomes 36. Vaccines 37. Gene Therapy 38. Nanoparticles 39. Digital Drug Delivery Systems 40. Natural Products Section 5: Biological Fluids 41 Bioanalysis of Biological Matrix Samples using Liquid Chromatography