How to Validate a Pharmaceutical Process

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. 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