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Modern GMP Auditing in the Biotech Industry
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- FormatePub
- ISBN8233157288
- EAN9798233157288
- Date de parution19/02/2026
- Protection num.pas de protection
- Infos supplémentairesepub
- ÉditeurLinda Balsamo
Résumé
As biotechnology continues to transform modern medicine, Good Manufacturing Practice (GMP) auditing has become more complex, data-driven, and critical than ever before. Modern GMP Auditing in the Biotech Industry is a comprehensive, forward-looking guide designed to equip auditors, quality professionals, and industry leaders with the knowledge and tools needed to navigate today's rapidly evolving regulatory landscape.
This ebook goes beyond traditional checklist-based audits to explore risk-based auditing methodologies, data integrity and digital compliance, automation and artificial intelligence, and the growing role of remote and hybrid audits. With a strong emphasis on biotech-specific challenges-including biologics, cell and gene therapies, aseptic processing, and global supply chains-the book provides practical insight into how GMP principles are applied in real-world, high-risk manufacturing environments.
Readers will gain a clear understanding of current regulatory expectations from authorities such as the FDA, EMA, and ICH, along with actionable guidance on auditing computerized systems, ensuring ALCOA+ data integrity, validating digital tools, and assessing emerging technologies. Real-world case studies illustrate common failure modes, effective remediation strategies, and best practices drawn from biotech manufacturing, quality systems, and regulatory inspections.
Written for both experienced auditors and professionals expanding into GMP auditing roles, this guide also addresses auditor competency, ethics, communication skills, and continuous improvement, reinforcing the critical role auditors play in fostering a strong quality culture. By integrating science-based risk assessment with modern audit techniques, the book supports more meaningful audits that drive compliance, operational excellence, and patient safety.
Whether you are a GMP auditor, quality assurance professional, regulatory specialist, or biotech leader, Modern GMP Auditing in the Biotech Industry serves as an essential reference for conducting effective audits today-and preparing for the future of GMP oversight.
This ebook goes beyond traditional checklist-based audits to explore risk-based auditing methodologies, data integrity and digital compliance, automation and artificial intelligence, and the growing role of remote and hybrid audits. With a strong emphasis on biotech-specific challenges-including biologics, cell and gene therapies, aseptic processing, and global supply chains-the book provides practical insight into how GMP principles are applied in real-world, high-risk manufacturing environments.
Readers will gain a clear understanding of current regulatory expectations from authorities such as the FDA, EMA, and ICH, along with actionable guidance on auditing computerized systems, ensuring ALCOA+ data integrity, validating digital tools, and assessing emerging technologies. Real-world case studies illustrate common failure modes, effective remediation strategies, and best practices drawn from biotech manufacturing, quality systems, and regulatory inspections.
Written for both experienced auditors and professionals expanding into GMP auditing roles, this guide also addresses auditor competency, ethics, communication skills, and continuous improvement, reinforcing the critical role auditors play in fostering a strong quality culture. By integrating science-based risk assessment with modern audit techniques, the book supports more meaningful audits that drive compliance, operational excellence, and patient safety.
Whether you are a GMP auditor, quality assurance professional, regulatory specialist, or biotech leader, Modern GMP Auditing in the Biotech Industry serves as an essential reference for conducting effective audits today-and preparing for the future of GMP oversight.
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