Is it possible to use the results of collaborative trials for analytical methods to prove the laboratory- and product-specific validation of a method? From the perspective of this EMA reflection paper the concrete specifications are missing. These will be developed in the future. Find out more in this news.
GMP News: EMA publishes Document on the Validation of analytical Methods
On 26 June 2014, the European Medicines Agency (EMA) published the concept paper “Transferring quality control methods validated in collaborative trials to a product/laboratory specific context”.
To accept a method an authority always requires a scientific validation. The same applies when existing methods are to be replaced, reduced or to be optimized (3R = replacement, reduction, refinement). Many of these new methods principally represent an improvement compared to the old “standard” methods and therefore are acceptable from a regulatory perspective.
The scientific proof of validation also includes the evidence of the…
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