Division 3.1.3 Validation according to alternative models

When alternative validation procedures are applied, the underlying model and strategy with the respective prerequisites, assumptions and formulae shall be laid down in the validation protocol or at least references shall be given to their availability. In the following an example for an alternative approach is given. When applying e.g. the in-house validation model, the performance characteristics are determined in a manner that permits validation for major changes within the same validation procedure. This requires design of an experimental plan for validation.