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Full Product Details

Author:   Steven Ostrove (Ostrove Associates, Inc. Elizabeth, NJ, USA)
Publisher:   Elsevier Science Publishing Co Inc
Imprint:   Academic Press Inc
Dimensions:   Width: 15.20cm , Height: 1.30cm , Length: 22.90cm
Weight:   0.360kg
ISBN:  

9780128041482

ISBN 10:   012804148
Pages:   218
Publication Date:   17 June 2016
Audience:   Professional and scholarly ,  Professional & Vocational
Format:   Paperback
Publisher's Status:   Active
Availability:   Manufactured on demand  
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Table of Contents

1. Introduction Section I What is Process Validation and Why do Process Validation? 2. Defining Process Validation 3. Brief Review of the Regulations and Guidelines 4. The Role of Change Control Section II Stage I – Process Development 5. Starting the Process Validation Program 6. Equipment and Utility Qualification 7. Dealing with Computers and Automation Validation 8. Process Development Section II Process Qualification 9. The Process Validation Protocol 10. Dealing with Deviations Section III Continued Process Verification 11. Collecting and Evaluating Production 12. Use of Statistical Process Control – pPk, Pk, cPk, cP Section IV Other Related Activities 13. Cleaning- Verification to Validation 14. Facility Qualification

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Author Information

Dr. Ostrove has over 30 years of experience in validation compliance, quality assurance, and regulatory affairs. In addition, he has developmental and process expertise in mammalian cell culture and separation technology. His general pharmaceutical experience includes sterile techniques (Aseptic processing), Process Validation, Cleaning and Sterilization Validation, Packaging Systems, Process Development and Process Scale-up. He also has industry experience with the development and validation of PC and PLC-based computer control systems for the biotech and pharmaceutical markets, guidance on system optimization for CIP/SIP and has led teams for the review of all GMP documents starting with their preparation (e.g., protocols, SOPs, and validation master plans). Dr. Ostrove has worked on several consent degree remediation and audit teams and his experience covers both EU and US regulations. He is the author of the Elsevier short format book How to Validate a Pharmaceutical Process (Jun 2016, 9780128041482).

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