Analytical chemistry : an introduction to pharmaceutical GMP laboratory / Kim Huynh-Ba.

By: Huynh-Ba, Kim [author.]
Language: English Publisher: Hoboken, NJ : John Wiley & Sons, Inc., 2022Copyright date: ©2022Description: 1 online resource (xxx, 386 pages) : illustrationsContent type: text Media type: computer Carrier type: online resourceISBN: 9781119120919 ; 9781119680437; 1119680433; 9781119680468; 1119680468; 9781119680475; 1119680476Subject(s): Pharmaceutical industry -- Quality control | Analytical chemistry | Drugs -- Testing | Drug development | Pharmaceutical chemistry | Chemistry, PharmaceuticalGenre/Form: Electronic books.DDC classification: 615/.19 LOC classification: RS189 | .H89 2022Online resources: Full text is available at Wiley Online Library Click here to view Summary: "Analytical testing in the pharmaceutical industry is necessary to establish drug quality based on science and regulatory compliance. It requires analysts to acquire a solid understanding of analytical chemistry and also a thorough appreciation of pharmaceutical regulatory requirements to address day-to-day challenges and maintain a compliant state. Pharmaceutical laboratories are operated under Good Manufacturing Practices (GMP), thus a knowledge of this regulations is necessary to perform pharmaceutical testing of drug substance and drug products"-- Provided by publisher.
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Includes bibliographical references and index.

"Analytical testing in the pharmaceutical industry is necessary to establish drug quality based on science and regulatory compliance. It requires analysts to acquire a solid understanding of analytical chemistry and also a thorough appreciation of pharmaceutical regulatory requirements to address day-to-day challenges and maintain a compliant state. Pharmaceutical laboratories are operated under Good Manufacturing Practices (GMP), thus a knowledge of this regulations is necessary to perform pharmaceutical testing of drug substance and drug products"-- Provided by publisher.

About the Author
Kim Huynh-Ba, M.Sc., PMP, FAAPS, is the Chief Executive Officer and Managing Director of Pharmalytik LLC, where she provides consulting and training services to leading pharmaceutical companies and global organizations. She has decades of experience in strategic analytical development, risk management, strategic drug development, and stability sciences. She is an Adjunct Professor at Temple University School of Pharmacy and Illinois Institute of Technology (IIT) teaching GMPs and various regulatory compliance subjects.

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