Regulatory Roadmap: Navigating Compliance in the Pharmaceutical Industry

By Mirela Gorjanu

In the ever-evolving world of pharmaceutical manufacturing, staying compliant isn't optional; it's mission-critical.
Regulatory Roadmap: Navigating Compliance in the Pharmaceutical Industry is a must-have guide for professionals navigating the complex terrain of Good Manufacturing Practices (GMP), FDA/EMA regulations, and quality assurance in the pharmaceutical industry. Drawing from years of hands-on experience, the author breaks down global regulatory expectations and translates them into actionable strategies that ensure inspection readiness and sustainable compliance.
This book delivers clear guidance on: Building a compliant pharmaceutical quality systemMastering GMP documentation and data integrityHandling inspections, audits, and CAPAs with confidenceImplementing risk-based thinking and continuous improvementBridging the gaps between regulatory theory and production floor realitiesWhether you're a QA/QC expert, regulatory affairs professional, GMP auditor, or manufacturing leader, this book equips you with the tools to streamline compliance, avoid costly missteps, and foster a culture of excellence.

• Format: Paperback
• Language: English
• ISBN: B0FB48PKXS
• ISBN13: 9798285590583
• Release Date: May 2025
• Publisher: Independently Published
• Length: 80 Pages
• Weight: 0.26 lbs.
• Dimensions: 0.2" x 6.0" x 9.0"