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Pharmaceutical Computer Systems Validation: Quality Assurance, Risk Management and Regulatory Compliance de Guy Wingate

Pharmaceutical Computer Systems Validation: Quality Assurance, Risk Management and Regulatory Compliance: Drugs and the Pharmaceutical Sciences

Editat de Guy Wingate
en Limba Engleză Paperback – 14 oct 2024

Manualul Pharmaceutical Computer Systems Validation, aflat la a treia ediție substanțial revizuită, reprezintă o resursă fundamentală pentru profesioniștii din industriile farmaceutică și a dispozitivelor medicale. Observăm o tranziție clară de la metodele tradiționale de validare către abordări moderne, adaptate la dinamica actuală a dezvoltării software. Subliniem integrarea noilor capitole dedicate metodologiilor agile și inteligenței artificiale, elemente care reflectă maturizarea tehnologică a sectorului. Cartea este organizată riguros în 23 de capitole, urmărind progresia logică a unui proiect: de la managementul organizațional și capturarea cerințelor, la codare, testare și, în final, mentenanță și retragere.

Comparabil cu Validating Pharmaceutical Systems de John Andrews în ceea ce privește rigoarea explicării cerințelor GCP, GLP și GMP, prezentul volum se distinge prin actualizarea masivă pentru era digitală, incluzând ghiduri recente despre integritatea datelor de la FDA, EU și MHRA. Notăm cu interes modul în care editorul Guy Wingate a reușit să echilibreze teoria cu practica prin cele 20 de studii de caz detaliate. Acestea oferă soluții concrete pentru sisteme complexe, de la LIMS la tehnologii blockchain și cloud. Față de lucrarea sa anterioară, Validating Corporate Computer Systems, unde accentul cădea pe sistemele corporative mari precum ERP sau MRP II, această ediție extinde spectrul către dispozitive mobile și sisteme activate de AI, oferind o viziune holistică asupra conformității de reglementare în contextul digitalizării accelerate.

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Specificații

ISBN-13: 9781032917511
ISBN-10: 1032917512
Pagini: 798
Ilustrații: 320
Dimensiuni: 178 x 254 x 46 mm
Greutate: 0.45 kg
Ediția:2
Editura: CRC Press
Colecția CRC Press
Seria Drugs and the Pharmaceutical Sciences

Locul publicării:Boca Raton, United States

Public țintă

Academic and Professional Practice & Development

De ce să citești această carte

Această lucrare este esențială pentru specialiștii în asigurarea calității și inginerii de sistem care activează în domenii reglementate. Cititorul câștigă acces la metodologii practice de implementare a ghidului GAMP 5 și strategii de gestionare a inspecțiilor regulatorii. Este un instrument indispensabil pentru alinierea proceselor interne la cele mai noi cerințe globale privind integritatea datelor și validarea software-ului bazat pe inteligență artificială.

Despre autor

Guy Wingate este un expert recunoscut la nivel internațional în domeniul validării sistemelor computerizate și al conformității de reglementare în industria Life Sciences. În calitate de editor și autor, a coordonat numeroase lucrări de referință în seria Drugs and the Pharmaceutical Sciences, fiind o voce influentă în interpretarea ghidurilor ISPE și GAMP. Experiența sa vastă în managementul riscului și auditarea sistemelor informatice se reflectă în abordarea pragmatică a volumelor sale, care servesc drept standard de bune practici pentru companiile farmaceutice globale.

Cuprins

Foreword to the Second Edition, Foreword to the First Edition, Preface, Contributor Biographies, Abbreviations, Contributors, 1. Introduction, 2. Organization and Management, 3. Supporting Processes, 4. Prospective Verification and Validation, 5. Project Initiation and Compliance Determination, 6. Requirements Capture and Supplier (Vendor) Selection, 7. Design and Development, 8. Coding, Configuration, and Build, 9. Development Testing, 10. User Qualification and Authorization to Use, 11. Operation and Maintenance, 12. Phaseout and Withdrawal, 13. Electronic Records and Electronic Signatures, 14. Regulatory Inspections, 15. Compliance Strategies, 16. Capabilities, Measures, and Performance, 17. Practical Troubleshooting, 18. Concluding Remarks, 19. Case Study 1: Computerized Analytical Laboratory Systems, 20. Case Study 2: Chromatography Data Systems, 21. Case Study 3: Laboratory Information Management Systems, 22. Case Study 4: Clinical Systems, 23. Case Study 5: Control and Monitoring Instrumentation, 24. Case Study 6: Process Control Systems, 25. Case Study 7: Manufacturing Execution Systems and Electronic Batch Records, 26. Case Study 8: Building Management Systems, 27. Case Study 9: Engineering Management Systems, 28. Case Study 10: Desktop Applications Including Spreadsheets, 29. Case Study 11: Databases, 30. Case Study 12: Electronic Document Management Systems, 31. Case Study 13: Enterprise Resource Planning Systems, 32. Case Study 14: Marketing and Supply Applications, 33. Case Study 15: IT Infrastructure and Associated Services, 34. Case Study 16: Internet/Intranet Applications, 35. Case Study 17: Medical Devices and Their Automated Manufacture, 36. Case Study 18: Blood Establishment Computer Systems, 37. Case Study 19: Process Analytical Technology, 38. Case Study 20: Computer Applications Supporting the Supply of Biotechnology Products, Glossary, Index

Descriere scurtă

Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. Ensuring that organizations transition smoothly to the new system, this guide explains how to implement the new GMP paradigm while maintaining continuity with current practices. In addition, all 24 case studies from the previous edition have been revised to reflect the new system. Key topics in Pharmaceutical Computer Systems Validation, Second Edition include:
  • GAMP5, ASTM 2500, EU GMP (Annex 11), and US GMP revisions to regulatory requirements for electronic records and signatures that should be published in 2008
  • ICH Guidance Q8, Q9, and Q10 expectations
  • FDA cGMPs for the 21st Century Initiative and associated guidance
  • PIC/S Guidance on Good Practice for Computerized Systems in GxP Environments
  • WK9864 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
  • the indirect developments from FDA/EU/Japan regulators and industry
  • the role of QA department, and internal and external suppliers
  • the integration of computer systems validation into single overall approach for wider system
  • practical guidance on handling common high, medium, and low risk issues that can occur during the life cycle of a computer system
  • managing outsource partners and handling legacy systems
  • topical issues uncovered by regulatory authorities including US FDA

Notă biografică

Guy Wingate, PhD, was Vice President & Compliance Officer and before that Director Global Computer Validation at GlaxoSmithKline until his recent retirement. A well‑known speaker on computer validation, he has over 30 years of experience in the pharmaceutical industry. He has been a visiting lecturer at the University of Manchester’s M.Sc. in Pharmaceutical Engineering Advanced Training program and the Dublin Institute of Technology’s accredited M.Sc. in Validation Science program. He is an active member of the ISPE and served as Chair of the GAMP Council for 10 years, which is responsible for the internationally recognized suite of GAMP® Guides on computer compliance. Guy led the teams who produced the original GAMP®5 Guide: A Risk Based Approach to Compliant GxP Computerized Systems and the GAMP® Good Practice Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures. His extensive list of published work also includes the books Validating Automated Manufacturing and Laboratory Applications, Validating Corporate Computer Systems and previous editions of this book Pharmaceutical Computer Systems Validation.