Active pharmaceutical ingredients : development, manufacturing, and regulation

✍ Scribed by Stanley Nusim

Publisher: Informa Healthcare
Year: 2010
Tongue: English
Leaves: 452
Series: Drugs and the pharmaceutical sciences, v. 205
Edition: 2
Category: Library

No coin nor oath required. For personal study only.

✦ Table of Contents

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

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