Baseline Guide Vol 7: Risk-Based Manufacture of Pharma Products 2nd Edition

Published: July 2017
Pages: 182

• Table of Contents
• Special Pricing for Emerging Economies
• FAQs

Executive Summary

This second edition of the ISPE Baseline® Guide on Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP) offers a structured approach for managing cross contamination risk in pharmaceutical manufacturing. Aligned with ICH Q9 quality risk management principles, it provides essential guidance for implementing science-based, health-based exposure limits (HBELs) and risk control strategies in shared facilities.

What You'll Learn

The Risk-MaPP Guide presents a systematic method for evaluating and controlling cross contamination risks in multiproduct facilities. Designed for real-world implementation, this resource assists manufacturers in:

• Applying pharmaceutical risk assessment methodologies in accordance with ICH Q9 quality risk management frameworks
• Defining acceptable exposure limits using health-based exposure metrics such as PDE and ADE
• Selecting appropriate risk control strategies, ranging from administrative controls to full facility dedication
• Supporting compliance with evolving global regulatory expectations, including EMA and FDA requirements
• Maintaining product quality and ensuring operator safety through validated, lifecycle-based cleaning processes

New in This Edition

The second edition builds on the foundational principles of the original Risk-MaPP Guide while incorporating critical regulatory and scientific updates:

• Updated EU GMP guidance on using ICH Q9 quality risk management to control cross contamination
• EMA guidance on setting HBELs in shared facilities, equating PDE and ADE
• Integration of ICH M7 guidelines on mutagenic impurities and their toxicological thresholds
• Adoption of lifecycle approaches to process validation, with an emphasis on ongoing cleaning validation
• Reorganization of content to align more closely with the ICH Q9 quality risk management process
• A new application example based on enhanced industry experience with cross contamination risk assessments

Who Should Use This Guide

This Guide is essential for professionals engaged in pharmaceutical risk management within shared manufacturing environments, including:

• Quality assurance and quality control personnel
• Regulatory affairs professionals
• Process engineers and validation experts
• Facility and operations managers responsible for multiproduct plant design or operation

Conclusion

The ISPE Risk-MaPP Guide provides a scientifically rigorous and regulatory-aligned framework for managing the risk of cross contamination in pharmaceutical manufacturing. With updated methodologies and practical examples, this resource helps companies implement effective control strategies while supporting global compliance.

Available in Russian
Базовое Руководство ISPE: Производство лекарственных средств на основе оценки рисков
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