Bioassay qualification and validation survey 2019
The survey assumes that qualification describes activities which demonstrate suitability of a method for use in early stages of product development while full method validation using a pre-approved protocol with acceptance criteria is performed prior to using a method for later stages of development and commercialization.Assay Qualification & Validation Definition.
The survey questions cover matters such as:
- Guidelines do you use for your validation experimental design
- Qualification parameters and levels used
- Acceptance criteria
- Personal and functions involved
- Provision and preparation of samples
- Potency levels and linearity considered
- Use of DoE and QbD and how these change in development phases
- Specification ranges
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