Principles of Parental Solution Validation: A Practical Lifecycle Approach

Principles of Parental Solution Validation: A Practical Lifecycle Approach covers all aspects of the activities required in the development and process validation of a parenteral product. By using a lifecycle approach, this book discusses the latest technology, compliance developments, regulatory considerations and recent 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 in order to address and offer solutions to the daily challenges facing practitioners in this area. Discusses international and domestic regulatory considerations in every sectionFeatures 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 design studies, scale-up and technology transfer activities, problem-solving, and more INDICE: IntroductionUpdate of new developments, regulatory trends/citationsStage 1 - Process DesignStage 2 - Process Qualification Stage 3 - Continued Process VerificationConclusion

• ISBN: 978-0-12-809412-9
• Editorial: Academic Press
• Encuadernacion: Rústica
• Páginas: 208
• Fecha Publicación: 01/11/2017
• Nº Volúmenes: 1
• Idioma: Inglés