Steven Ostrove,
Steven (Ostrove Associates, Inc. Elizabeth, NJ, USA) Ostrove
How to Validate a Pharmaceutical Process
Paperback Engels 2016 9780128041482
Verwachte levertijd ongeveer 9 werkdagen
Samenvatting
How to Validate a Pharmaceutical Process provides a “how to approach to developing and implementing a sustainable pharmaceutical process validation program. The latest volume in the Expertise in Pharmaceutical Process Technology Series, this book illustrates the methods and reasoning behind processes and protocols. It also addresses practical problems and offers solutions to qualify and validate a pharmaceutical process. Understanding the “why is critical to a successful and defensible process validation, making this book an essential research companion for all practitioners engaged in pharmaceutical process validation.
Specificaties
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Inhoudsopgave
<p>1. Introduction</p> <p>Section I What is Process Validation and Why do Process Validation?2. Defining Process Validation3. Brief Review of the Regulations and Guidelines4. The Role of Change Control</p> <p>Section II Stage I – Process Development5. Starting the Process Validation Program6. Equipment and Utility Qualification7. Dealing with Computers and Automation Validation8. Process Development</p> <p>Section II Process Qualification 9. The Process Validation Protocol 10. Dealing with Deviations</p> <p>Section III Continued Process Verification 11. Collecting and Evaluating Production12. Use of Statistical Process Control – pPk, Pk, cPk, cP</p> <p>Section IV Other Related Activities13. Cleaning- Verification to Validation14. Facility Qualification</p>
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