Equipment Qualification in the Pharmaceutical Industry

Name: Equipment Qualification in the Pharmaceutical Industry
Price: 224.95 AUD
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ISBN: 9780128175682

Steven Ostrove, PhD (Ostrove Associates, Inc. Elizabeth, NJ, USA)

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English

Academic Press Inc
14 June 2019

Production & quality control management; Pharmaceutical industries; Epidemiology & medical statistics; Pharmacology; Pharmacy & dispensing

Series: Aspects of Pharmaceutical Manufacturing

Equipment Qualification in the Pharmaceutical Industry

By: Steven Ostrove PhD (Ostrove Associates Inc. Elizabeth NJ USA)
Imprint: Academic Press Inc
Country of Publication: United States
Dimensions: Height: 229mm, Width: 152mm,
Weight: 360g
ISBN: 9780128175682
ISBN 10: 0128175680
Series: Aspects of Pharmaceutical Manufacturing
Pages: 234
Publication Date: 14 June 2019
Audience: Professional and scholarly , College/higher education , Undergraduate , Further / Higher Education
Format: Paperback
Publisher's Status: Active

1. Introduction2. Documentation - Getting Ready 3. Quality Systems4. Equipment Design Considerations5. Equipment Controls and Automation6. Preparing the Protocols - General Approach7. Commissioning & Decommissioning8. Equipment Qualification Protocols9. Equipment Checklist10. Protocol Execution11. Protocol Reports AppendixA. DefinitionsB. ExamplesC. References

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).