1. Introduction / Stanley H. Nusim -- 2. Bulk drugs : the process development task / Carlos B. Rosas -- 3. Bulk drugs : process design, technology transfer, and first manufacture / Carlos B. Rosas -- 4. Design and construction of API manufacturing facilities / Steven Mongiardo -- 5. Regulatory affairs : requirements and expectations / John Curran -- 6. Regulatory affairs : guidelines, evolving strategies, and issues / John Curran -- 7. Validation of active pharmaceutical ingredients / James Agalloco and Phil DeSantis -- 8. Quality of active pharmaceutical ingredients / Michael C. Vander Zwan and Carlos Yuraszeck -- 9. Environmental control / Bruce Wallington -- 10. Thermochemical process safety : an introduction / Carlos B. Rosas -- 11. Design and operating practices for safety / Stanley S. Grossel -- 12. Plant operations / Stanley H. Nusim -- 13. Sterile bulk active pharmaceutical ingredient production / James Agalloco and Phil DeSantis -- 14. Biological production of active pharmaceutical intermediates / Max J. Kennedy, Randolph L. Greasham, and Stephen W. Drew -- 15. Supply management / Victor J. Catalano -- 16. Equipment maintenance and reliability / Kaizad P. Sunavala.