Transcription of Assay Qualification/Validation – a Reviewer’s Expectations
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Assay Qualification/Validation – a Reviewer’s Expectations
Assay Qualification/Validation . a Reviewer's Expectations Sarah Kennett Division of Monoclonal Antibodies Office of Biotechnology Products OPS/CDER/FDA. 1. October 20, 2010. Disclaimer The views and opinions expressed here are my own and should not be used in place of regulations, published FDA guidances or discussions with the Agency. These views reflect CDER/OPS/OBP. discussions. This talk is focused on analytical assays used to assess drug substance, drug product, and in-process materials. 2. Overview Why this subject? What does FDA say officially? What do we OBP product reviewers mean by qualification and validation ? Some Expectations 3. Person X: Someone told me assays need to be validated to start Phase 2 studies. Me: No, unless there is a scientific reason, submission of Assay validation isn't required until the BLA is submitted. However, you need to be using qualified assays from the beginning.
Validation vs. Qualification Are we speaking the same language? Lifecycle (borrowing from Process Validation) Stage 1 – Assay Design: The assay is defined during this stage based on knowledge gained through development activities. Stage 2 – Assay Qualification: During this stage, the assay design is confirmed as being capable of producing
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