How to Validate a Pharmaceutical Process
Part of the Expertise in Pharmaceutical Process Technology Series
Published on 17. June 2016
Book
Paperback/Softback
218 pages
978-0-12-804148-2 (ISBN)
Description
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.
More details
Series
Language
English
Place of publication
San Diego
United States
Publishing group
Elsevier Science Publishing Co Inc
Target group
Professional and scholarly
Pharmaceutical personnel, including research and development professionals, pharmaceutical consultants, team leaders and department heads
Dimensions
Height: 229 mm
Width: 152 mm
Weight
360 gr
ISBN-13
978-0-12-804148-2 (9780128041482)
Copyright in bibliographic data and cover images is held by Nielsen Book Services Limited or by the publishers or by their respective licensors: all rights reserved.
Schweitzer Classification
Other editions
Additional editions
Steven Ostrove
How to Validate a Pharmaceutical Process
E-Book
06/2016
Academic Press
€35.95
Available for download
Person
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).
Content
1. Introduction
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
Section II Stage I - Process Development5. Starting the Process Validation Program6. Equipment and Utility Qualification7. Dealing with Computers and Automation Validation8. Process Development
Section II Process Qualification 9. The Process Validation Protocol 10. Dealing with Deviations
Section III Continued Process Verification 11. Collecting and Evaluating Production12. Use of Statistical Process Control - pPk, Pk, cPk, cP
Section IV Other Related Activities13. Cleaning- Verification to Validation14. Facility Qualification
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
Section II Stage I - Process Development5. Starting the Process Validation Program6. Equipment and Utility Qualification7. Dealing with Computers and Automation Validation8. Process Development
Section II Process Qualification 9. The Process Validation Protocol 10. Dealing with Deviations
Section III Continued Process Verification 11. Collecting and Evaluating Production12. Use of Statistical Process Control - pPk, Pk, cPk, cP
Section IV Other Related Activities13. Cleaning- Verification to Validation14. Facility Qualification