Principles of Parenteral Solution Validation

Principles of Parenteral Solution Validation: A Practical Lifecycle Approach covers all aspects involved in the development and process validation of a parenteral product. By using a lifecycle approach, this book discusses the latest technology, compliance developments, and regulatory considerations and trends, from process design, to divesting. As part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin, this 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.

• Discusses international and domestic regulatory considerations in every section
• Features callout boxes that contain points-of-interest for each segment of the audience so readers can quickly find their interests and needs
• Contains important topics, including risk management, the preparation and execution of properly designed studies, scale-up and technology transfer activities, problem-solving, and more

Pharmaceutical and associated industry professionals involved in process development and qualification of parenteral products, including R&D personnel involved in manufacturing, technology transfer and quality assurance, as well as process engineers and regulatory officials

Update of new developments, regulatory trends/citations
Stage 1. Process Design
Stage 2. Process Qualification
Stage 3. Continued Process Verification