Principles of Parenteral Solution Validation: A Practical Lifecycle Approach

Written by Igor Gorsky, this comprehensive guide covers all aspects of developing and process validating parenteral products, from design to divestment. As part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin, this book provides a lifecycle approach to addressing the latest technology, compliance developments, and regulatory considerations and trends.

International and Domestic Regulatory Considerations

This book covers regulatory considerations from around the world, ensuring that readers are well-versed in the regulations and guidelines that govern the development and validation of parenteral solutions.

Real-World Examples and Case Studies

The book incorporates numerous case studies and real-world examples that address timely problems and offer solutions to the daily challenges facing practitioners in this area. These examples provide valuable insights and practical guidance for overcoming obstacles and achieving success.

Key Topics Covered

• Risk management and mitigation strategies
• Preparation and execution of properly designed studies
• Scale-up and technology transfer activities
• Problem-solving techniques and best practices

With its focus on practical applications and real-world examples, Principles of Parenteral Solution Validation: A Practical Lifecycle Approach is an essential resource for pharmaceutical professionals, regulatory affairs specialists, and quality control experts.

Publisher: Elsevier Science

Publication Date: November 27, 2019