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Good Manufacturing Practices for Pharmaceuticals, Seventh Edition -

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    Brand new, In English, Fast shipping from London, UK; Tout neuf, en anglais, expédition rapide depuis Londres, Royaume-Uni;ria9781032178387_dbm

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        Présentation Good Manufacturing Practices For Pharmaceuticals, Seventh Edition de Format Broché

         - Livre Médecine, Pharmacie, Paramédical, Médecine vétérinaire

        Livre Médecine, Pharmacie, Paramédical, Médecine vétérinaire - 01/09/2021 - Broché - Langue : Anglais

        . .

      • Editeur : Crc Press
      • Langue : Anglais
      • Parution : 01/09/2021
      • Format : Moyen, de 350g à 1kg
      • Nombre de pages : 388
      • Expédition : 671
      • Dimensions : 25.4 x 17.8 x 2.1
      • ISBN : 1032178388



      • Résumé :
        This book provides insight into the world of pharmaceutical quality systems and the key elements that must be in place to change the business and organizational dynamics from task-oriented procedure-based cultures to truly integrated quality business systems that are self-detecting and correcting. Chapter flow has been changed to adopt a quality

        Biographie:

        Graham P. Bunn is the president of GB Consulting LLC, in Pennsylvania, a company providing regulatory compliance, quality systems, regulatory action remediation, training and technical consulting services for pharmaceutical, biotechnology and other FDA and European Medicines Agency (EMA)-related industries. Before founding GB Consulting LLC, Graham experienced broad good manufacturing practices (GMP) and FDA inspection experience through his work in the pharmaceutical industry, including working for SmithKline Beecham PLC (GlaxoSmithKline PLC), Wyeth Pharmaceuticals (Pfizer), and Astra Merck Inc. (AstraZeneca PLC). His career experience includes management positions and responsibilities as a corporate quality auditor and in quality assurance, validation, and clinical trials manufacturing and packaging. He has developed and facilitated numerous highly interactive learning and training workshops worldwide. Graham is also the author of several book chapters and journal articles. A member of the Regulatory Affairs Professional Society (RAPS). Graham received a BSc in pharmacy from Brighton University, England, and an MSc in quality assurance and regulatory affairs from Temple University, in Philadelphia.

        Sommaire:

        Preface

        Editor

        Contributors

        1. Status and Applicability of U.S. Regulations: CGMP

        Graham P. Bunn

        2. Quality Management Systems and Risk Management

        Joseph C. Near

        3. Management Responsibility and Control

        John E. Snyder

        4. Organization and Personnel

        Graham P. Bunn and Joanna B. Gallant

        5. Finished Pharmaceuticals: General Provisions

        Graham P. Bunn

        6. Production and Process Controls

        Jocelyn A. Zephrani

        7. Records and Reports

        Graham P. Bunn

        8. Clinical Trial Supplies

        David Stephon

        9. Contracting and Outsourcing

        Joseph C. Near

        10. Buildings and Facilities

        Robert Del Ciello

        11. Equipment

        Robert Del Ciello and Joseph T. Busfield

        12. Control of Components and Drug Product Containers and Closures

        Graham P. Bunn

        13. Holding and Distribution

        Andrew Acker

        14. Returned and Salvaged Drug Products

        Graham P. Bunn

        15. Active Pharmaceutical Ingredients

        Joseph C. Near

        16. Pharmaceutical Excipient Good Manufacturing Practices

        Irwin Silverstein

        17. Packaging and Labeling Control

        Graham P. Bunn

        18. Laboratory Controls

        Alex M. Hoinowski

        19. Microbiological Aspects of Pharmaceutical Aseptic Processing in the Compounding Pharmacy

        Dawn McIver

        20. CGMP Enforcement Alternatives in the United States

        Daniel G. Jarcho and Cathy L. Burgess

        21. FDA Inspection Process

        Cathy L. Burgess and Daniel G. Jarcho

        22. FDA Pre-approval Inspections

        Cathy L. Burgess, Justin Mann, and Seth Olson

        23. Worldwide Good Manufacturing Practices

        Dominic Parry

        24. Data Integrity and Fundamental Responsibilities

        Randy Hightower and Michele Pruett

        Index

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