Modern Validation - Case Studies

Programme

History of Validation with regard to Annex 15

• Validation in the 70´s – focus on sterile production
• FIP Validation Guideline
• PIC Validation Conference 1982
• The mother guideline of Validation: FDA´s Process Validation Guideline 1987
• PIC/PH 1/96
• Annex 15 2001
• EMEA Note for Guidance on Process Validation
• FDA Guidance CPG 7132.c08
• WHO Process Validation Guideline
• FDA Process Validation: Guidance for Industry
• EMA Guideline on Process Validation
• Annex 15 Revision
• WHO revision of Validation Guidelines
• EMA: Biotech Process Validation Guideline

• History of Annex 15 and FDA Process Validation Guidance
• Role of EMA Process Validation Guideline vs. Annex 15
• Similarities Annex 15 vs FDA Process Validation Guidance
• Differences Annex 15 and FDA Process Validation Guidance

• Annex 15´s 8-stage Qualification
• ASTM 2500 as an alternative
• Case Study Qualification regarding ASTM 2500

• ICH Q 8
• Continuous Process Verification
• Case Study: Design Space, PAT Application, Design Space Verification, Process Governance during DP lifecycle

• Ongoing Process Verification vs. Continued Process Verification
• Case Study
• Outlook

• Qualification, Validation, Verification
• Requirements of Annex 15
• Guideline Good Transportation Practice
• Case Study

• Requirements of Annex 15
• Qualification of packaging lines
• The valiation of primary vs secondary packaging processes
• Case Study

• Requirements of Annex 15
• EMA guidance on PDE: PDE and ADE similarities and difference, Setting cleaning limit – risk assessment approach