Discussion Papers

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Read the latest discussion papers on Process Validation and give us your feedback!

Let the authors know about process validation approaches that have worked for you and your company and lessons learned from proposed approaches. Your industry examples and direction could be used to create an ISPE Good Practice Guide.

Topic 1 – Stage 2 Process Validation: Determining and Justifying the Number of Process Performance Qualification Batches

This discussion paper proposes ideas for answering the question “How many process performance qualification batches (PV stage 2) are needed to demonstrate a high degree of assurance in the manufacturing process and that the control strategy is sufficiently robust to support commercial release of the product?” The purpose of this paper is to stimulate further discussion and suggest potential practical application.

Note: Version 1 of this document has been replaced to correct a statistical calculation error.

Topic 2 – Stage 3 Process Validation: Applying Continued Process Verification Expectations to New and Existing Products

This discussion paper proposes ideas for answering the questions “How is Stage 3 monitoring and testing following PPQ determined, as part of the lifecycle approach to PV?” “What is the impact of the lifecycle approach to monitoring and testing of existing/legacy products?” The purpose of this paper is to stimulate further discussion and suggest potential practical application.

Last Update: 28 February 2014

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