Discussion Papers

Lifecycle Approach to Biotech Process Validation
Guidance Documents

Lifecycle Approach to Biotech Process Validation

This discussion paper proposes ideas for answering the questions about the application of the lifecycle approach to PV to Biotech product...
Stage 3 Process Validation: Applying Continued Process Verification Expectations
Guidance Documents

Stage 3 Process Validation: Applying Continued Process Verification Expectations

This discussion paper proposes ideas for answering the questions “How is Stage 3 monitoring and testing following PPQ determined, as part of the...