Key steps in the validation of the pharmaceutical manufacturing process per US FDA Guidance Document:

Process Validation Guidance Document (Pharma), US FDA,  Jan 2011

• Stage 1 – Process Design
• Stage 2 – Qualification
  • Part 1 – Facility Design
  • Part 2 – Qualification of Utilities & Equipment
    • Subsection 1 – Installation Qualification
    • Subsection 2 – Operational Qualification
    • Subsection 3 – Performance Qualification
  • Part 3 – Process Performance Qualification (PPQ)  
• Stage 3 – Continued Process Verification (ongoing)

John E. Lincoln, jel@jelincoln.com