Understanding Process Validation

About the Course

This eLearning module on Process Validation and Life Cycle Approach offers a comprehensive overview of validation principles, regulatory expectations, and industry best practices. It explores the evolution of validation, the shift to a life cycle approach, and the critical stages—Process Design, Performance Qualification, and Continued Process Verification. With emphasis on ICH Q8, equipment qualification, PPQ execution, and ongoing process monitoring, the module equips learners to ensure product quality, process control, and compliance with Schedule M and WHO guidelines.

Content

• Understanding Validations
  • What all needs to be validated?
  • Evolution of process validation
• Process Validation: Life Cycle Approach
  • Expectations from a drug and drug manufacturing process
  • Past approaches to validation
  • Process validation failures: limited understanding of the process
  • Process validation guidelines & Underlying principles of PV guidance
  • PV: Leveraging design and control
  • Stages of Validation: Life cycle approach
• Stage 1: Process Design
  • ICHQ8 – Process Development and Quality by Design
  • Process design: control of variation and its examples
• Stage 2: Performance Qualification
  • Process design, and process qualification elements
  • Equipment and utility qualification: Lifecycle approach and V Model
  • Factory Acceptance Test
  • Equipment qualification stages including IQ, OQ, PQ and periodic verification
  • Determining the importance of Process Performance Qualification Batches
  • PPQ batches: Sampling plan and protocol, execution, reporting & release
• Stage 3: Continued Process Validation and regulatory aspects of PV
  • CPV activities: Data collection, and benefits
  • Regulatory focus and observations
  • Key PV requirements in Schedule M and WHO

Summary and Conclusion: Key takeaways, Stages of PQ and process overview

Final Evaluation: 3 attempts to achieve the passing score in the evaluation