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Understanding and Implementing CGMPs
- 1st Edition - January 1, 2029
- Author: Steven Ostrove
- Language: English
- Paperback ISBN:9 7 8 - 0 - 1 2 - 8 2 4 4 7 4 - 6
- eBook ISBN:9 7 8 - 0 - 3 2 3 - 8 5 9 9 9 - 8
Understanding and Implementing CGMPs present the current Good Manufacturing Practices (GMPs) in a new manner designed to help practical application and understanding. Each sect… Read more
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Request a sales quoteUnderstanding and Implementing CGMPs present the current Good Manufacturing Practices (GMPs) in a new manner designed to help practical application and understanding. Each section of Part 211 of the GMPs are presented as a whole entity, not just individual requirements, allowing the reader to understand the reasoning behind them. The specific regulations are also presented, but they are integrated into the manufacturing process to ensure comprehension and enforcement. The volume in the Aspects of Pharmaceutical Manufacturing series covers all of the subsections of Part 211 (GMPs for Finished Pharmaceuticals). Understanding and Implementing CGMPs is essential reading for new employees working in the industry, employees changing positions or looking to advance their carriers in QA, production or other pharma area of manufacturing as well as university graduate classes in Pharmaceutical Engineering.
- Discusses GMPs from the ‘ground up’ to present them in a wholistic manner
- Applies GMPs to specific manufacturing steps or procedures
- Explains GMPs with examples to demonstrate application and reason for implementation
Those starting out in the pharmaceutical industry as well as those primarily in the first few years of work in the industry. The book can be used for more advanced personnel as a review or source of ideas in improving compliance to the CGMP requirements and thus make the process more compliant or more effective.
Can be used in classroom settings such as CGMP classes at the graduate and undergraduate level
Section 1 - INTRODUCTION 1. Introduction – Understanding the basis for the GMPs 2. Flow of the GMPs 3. PART 210
Section 2 - PART 211 4. Subpart A – Scope & Definitions 5. Subpart B – Personnel 6. Subpart J – Records & Reports 7. Subpart I – Laboratory Control 8. Subpart C - Facilities 9. Subpart D Equipment 10. Subpart E – Container Closure 11. Subpart F – Production Control 12. Subpart G – Package & Label Control 13. Subpart H – Holding & Distribution 14. Subpart K – Return & Salvage
Section 3 - OTHER CONSIDERATIONS 15. Integrating Part 11 16. GMPs and Process Validation 17. Basic GMP Audit form
- No. of pages: 270
- Language: English
- Edition: 1
- Published: January 1, 2029
- Imprint: Academic Press
- Paperback ISBN: 9780128244746
- eBook ISBN: 9780323859998
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Steven Ostrove
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).
Affiliations and expertise
Ostrove Associates, Inc. Elizabeth, NJ, USA