Specification of Drug Substances and Products

Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Second Edition, presents a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development, validation of analytical methods, and their application in practice. This thoroughly revised second edition covers topics not covered—or not substantially covered—in the first edition, including method development and validation in the clinical phase, method transfer, process analytical technology, analytical life cycle management, special challenges with generic drugs, genotoxic impurities, topical products, nasal sprays and inhalation products, and biotechnology products.

The book's authors have been carefully selected as former members of the ICH Expert Working Groups charged with developing the ICH guidelines, and/or subject-matter experts in the industry, academia and in government laboratories.

• Presents a critical assessment of the application of ICH guidelines on method validation and specification setting
• Written by subject-matter experts involved in the development and application of the guidelines
• Provides a comprehensive treatment of the analytical methodologies used in the analysis, control and specification of new drug substances and products
• Covers the latest statistical approaches (including analytical quality by design) in the development of specifications, method validation and shelf-life prediction

Scientists, managers, educators and consultants involved in the development and regulation of pharmaceutical products, especially those concerned with the Chemistry, Manufacturing and Controls (CMC) aspects of drug development. Includes analytical chemists, preformulation scientists, formulation scientists, process chemists, process engineers, and pharmaceutical microbiologists as well as those involved in regulatory affairs, quality control and quality assurance. Academic researchers involved in drug research and development, particularly those who collaborate with industry or serve as consultants; faculty and students pursuing post-graduate degrees in Pharmaceutical Analysis, Pharmaceutics or Pharmaceutical Chemistry and certificates in Regulatory Affairs or Quality Assurance

PART 1 INTRODUCTION
1. Introduction
2. General Principles and Regulatory Considerations: Specifications and Shelf Life Setting
3. Application of Quality by Design (QbD) to the Development and Validation of Analytical Methods
4. General Principles and Regulatory Considerations: Method Development and Validation
5. Analytical Methods in the Clinical Phase of Development
6. Method Transfer
7. Process Analytical Technology
8. Analytical Procedure Life Cycle Management
9. Challenges of Analytics in Generic Products

PART 2 UNIVERSAL TESTS
10. Description and Identification
11. Assay and Impurities
12. Genotoxic 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. Nasal Sprays and Inhalation Products
21. Extractables and Leachables

PART 5 BIOTECHNOLOGY PRODUCTS
22. Regulatory Requirements for Setting Specifications
23. Specifications for Drug Substance
24. Specifications for Drug Product
25. Validation of Analytical Methods
26. Complex Biological Products

PART 6 PHARMACOPEIAL METHODS
27. Pharmacopeial Methods and Test

PART 7 BIOLOGICAL FLUIDS
28. Biological Fluids

PART 8 STERILE PRODUCTS
29. Microbial Methods and Endotoxin Testing