Active pharmaceutical ingredients
Subtitle: development, manufacturing, and regulation
By: edited by Stanley Nusim.
Contributors: Nusim, Stanley.
Edition: 2nd ed.
Series: Drugs and the pharmaceutical sciences -- 205; Drugs and the pharmaceutical sciences -- v. 205.
Publisher: Informa Healthcare
Published: 2009
Place of publication: New York
Language: eng
ISBN-13: 9781439803363
Subjects: Drug development; Pharmaceutical technology; Drugs -- Law and legislation; Pharmaceutical industry; Drug Industry -- organization & administration; Chemistry, Pharmaceutical; Drug Compounding; Legislation, Drug; Legislation, Pharmacy
Notes: Includes bibliographical references and index.
Table of contents: title: Process development, scaleup & design / Carlos B. Rosas; title: Technology transfer & first manufacture / Carlos B. Rosas; title: Plant design & construction / Steven Mongiardo; title: Regulatory requirements? : requirements and expectations / John Curran; title: Regulatory requirements : guidelines and evolving strategies / John Curran; title: Process validation / James Agalloco, Phil DeSantis; title: Quality assurance & control / Michael J. Vander Zwan, Carlos Yuraszeck; title: Environmental control / Bruce Wallington; title: Thermochemical process safety / Carlos B Rosas; title: Design and operating practices for safety / Stanley Grossel; title: Plant operations / Stanley H Nusim; title: Sterile bulk manufacturing / James Agalloco, Phil DeSantis; title: Biological manufacturing / Stephen Drew, Max J. Kennedy, Randolph L. Greasham; title: Supply management / Victor Catalano; title: Plant maintenance / Kaizad Sunavala.