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Validation of active pharmaceutical ingredients

Berry, Ira R., 1942-

Validation of active pharmaceutical ingredients

Berry, Ira R., 1942-

9781420025972

9780367801205

2nd ed.

1 online resource (xxix, 594 pages) : illustrations

1. Introduction / Daniel Harpaz -- 2. The legal framework for the regulation of active pharmaceutical ingredients / David F. Weeda [and others] -- 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 [and others] -- 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.

Much has happened in the area of bulk pharmaceutical good manufacturing practice (GMP) and validation since the first publication of Validation of Active Pharmaceutical Ingredients. Revised, updated, and expanded, this second edition includes new chapters addressing postapproval changes, technology transfer, international cGMP guidelines/FDA guidance progress, and facility inspection issues. The basic philosophy and principles of GMP and validation have not changed, but new terminology had been introduced, and old terminology had been better defined, improving the understanding of related concepts and principles. The book gives you a working knowledge of the regulatory process that will facilitate your organization's compliance with regulations.

Pharmaceutical industry -- Quality control.

Drugs -- Standards -- United States.

MEDICAL / Pharmacology

Berry, Ira R., 1942-

Harpaz, Daniel.

Taylor & Francis https://www.taylorfrancis.com/books/9781420025972

Taylor & Francis https://www.taylorfrancis.com/books/9780367801205

OCLC metadata license agreement http://www.oclc.org/content/dam/oclc/forms/terms/vbrl-201703.pdf