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Discussion Papers
Discussion Papers
Lifecycle Approach to Biotech Process Validation
Lifecycle Approach to Biotech Process Validation
1 August 2014
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
Stage 3 Process Validation: Applying Continued Process Verification Expectations
1 August 2012
This discussion paper proposes ideas for answering the questions “How is Stage 3 monitoring and testing following PPQ determined, as part of the...