1. Introduction / Daniel Harpaz -- 2. The legal framework for the regulation of active pharmaceutical ingredients / David F. Weeda ... [et al.] -- 3. The legal basis for validation / Irving L. Wiesen -- 4. Drug master files / Arthur B. Shaw -- 5. The FDA's perspectives on active pharmaceutical ingredient manufacturing, cGMP controls, and validation / Edwin Rivera Martn̕ez -- 6. Domestic and foreign API manufacturing facility audits and findings / Peter D. Smith -- 7. Validation of APIs : a case study / Nirmal Khanna -- 8. Active pharmaceutical ingredient validation : an overview and comparative analysis / Max S. Lazar -- 9. Impurities in drug substances and drug products / Stephen R. Byrn and Joseph G. Stowell -- 10. Investigating process deviations / Frank J. Golden -- 11. Technology transfer : active pharmaceutical ingredients / B.J. Evanoff and K.L. Hofmann, Jr. -- 12. Postapproval changes to bulk drug substances / Eric Sheinin ... [et al.] -- 13. Vendor qualification and certification / Ira R. Berry -- 14. Quality assurance systems / Fred C. Radford -- 15. Cleaning for active pharmaceutical ingredient manufacturing facilities / William E. Hall -- 16. Validation of sterile APIs / Robert V. Kasubick -- 17. Validation of biotechnology active pharmaceutical ingredients / Rob Murphy and Robert J. Seely -- 18. Microbiological attributes of active pharmaceutical ingredients / Karen Zink McCullough and John Shirtz -- 19. Excipients : facility, equipment, and processing changes / Irwin Silverstein -- 20. API terminology and documentation / Robert A. Nash.