Pharma Manufacturing: A Practical Guide
商品資訊
ISBN13:9798287251208
出版社:Independently published
作者:Mirela Gorjanu
出版日:2025/06/07
裝訂:平裝
規格:27.9cm*21.6cm*0.6cm (高/寬/厚)
商品簡介
商品簡介
Pharma Manufacturing: A Practical Guide is an essential resource for pharmaceutical professionals, quality experts, and students seeking a clear and structured understanding of modern drug manufacturing. This comprehensive guide bridges scientific principles with real-world application, offering insights grounded in Good Manufacturing Practices (GMP), regulatory expectations, and industry best standards.
Covering the full manufacturing lifecycle, from raw material sourcing and formulation to scale-up, batch release, and post-market control, this book brings clarity to complex pharmaceutical processes through practical examples, workflows, and compliance checklists.
Inside, you'll discover:
Empower your pharmaceutical expertise with practical tools and insights, crafted for today's fast-evolving regulatory landscape.
Covering the full manufacturing lifecycle, from raw material sourcing and formulation to scale-up, batch release, and post-market control, this book brings clarity to complex pharmaceutical processes through practical examples, workflows, and compliance checklists.
Inside, you'll discover:
- Step-by-step walkthroughs of manufacturing unit operations
- Key GMP requirements for equipment, facilities, and personnel
- Validation strategies for processes, cleaning, and analytical methods
- Risk management, CAPA, and audit-readiness tools
- Practical approaches to documentation, change control, and deviation handling
Empower your pharmaceutical expertise with practical tools and insights, crafted for today's fast-evolving regulatory landscape.
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