SERVICES
Method Validation
There are various stages in the life of an analytical method from early stage development to the monitoring of final product. It may take several years to get this far and it is unlikely that the method will survive unscathed even if the product does.
At each stage the requirements of the method and the validation that is required varies. When those changes occur and when it is appropriate to move to the next stage of validation is not an exact science.
The regulatory bodies, and in particular the FDA, have provided a unifying approach to acceptable standards which has enabled all companies working within the auspices of Good Practices to speak the same language and be universally understood.
However, this area is still one that is poorly understood despite excellent guidance documents. So working with an experienced partner that has a good working knowledge of the standards and a pragmatic approach to method validation can be enormously beneficial.