Equipment Qualification in the Pharmaceutical Industry

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).

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