
Principles of Parenteral Solution Validation
A Practical Lifecycle Approach
Description
Key Features
- 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
Readership
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
Table of Contents
1. Aseptic Process Validation, Part 1: Design and Planning
2. Aseptic Process Validation Design, Part 2: Aseptic Process Simulation Design
3. Quality Risk Management of Parenteral Process Validation, Part 1: Fundamentals
4. Equipment Cleaning Process
5. Quality Risk Management of Parenteral Process Validation, Part 2: A Risk-Based Quality Management System
6. Use of Statistics in Process Validation
7. Process Validation Stage 1: Parenteral Process Design
8. Process Validation Stage 2: Parenteral Process Performance Qualification
9. Process Validation Stage 3: Continued Process Verification
10. Preuse/Poststerilization Integrity Testing of Sterilizing Grade Filter
11. Environmental Monitoring
12. Isolators
13. Post Aseptic Fill Sterilization and Lethal Treatment
Product details
- No. of pages: 298
- Language: English
- Copyright: © Academic Press 2019
- Published: November 27, 2019
- Imprint: Academic Press
- Paperback ISBN: 9780128094129
- eBook ISBN: 9780128094464
About the Editors
Igor Gorsky
Affiliations and Expertise
Harold Baseman
Affiliations and Expertise
Ratings and Reviews
Latest reviews
(Total rating for all reviews)
Allan M. Sun Dec 12 2021
Great hands on book
Practical subjects of importance in current times