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Pharma Manufacturing: A Practical Guide

by Gorjanu, Mirela

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Description

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:
  • 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
Whether you're starting your journey in pharma or looking to strengthen operational and regulatory mastery, this guide will empower you to navigate pharmaceutical manufacturing with confidence and compliance.
Empower your pharmaceutical expertise with practical tools and insights, crafted for today's fast-evolving regulatory landscape.

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Product Details

  • Jun 7, 2025 Pub Date:
  • 9798287251208 ISBN-10:
  • 9798287251208 ISBN-13:
  • English Language