Sterilization Process Validation in Pharmaceutical Manufacturing

Outline

• Introduction to Sterilization in Pharma – Objectives and principles
• Sterilization Methods – Steam, dry heat, filtration, gas, and radiation
• Regulatory Requirements – EU GMP, WHO GMP, and ISO 11135/11137 standards
• Validation Stages – IQ, OQ, PQ for sterilization systems
• Biological Indicators and Process Monitoring
• Risk Assessment and Documentation
• Common Issues and Best Practices

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