Our staff are experienced at planning and undertaking method validation and method verification studies and, unless otherwise agreed with the client, we will work in accordance with the ICH requirements.
Our objective in the validation of an analytical procedure is to demonstrate that it is suitable for its intended purpose. We are usually able to compose the experimental work so that the appropriate validation characteristics can be considered simultaneously, providing a robust overall knowledge of the capabilities of the analytical procedure. This could apply to specificity, linearity, range, accuracy and precision.
We understand that companies have different requirements and so our aim is to work with our clients to meet their validation needs, and in accordance with published guidelines, to ensure that we demonstrate that each method is fit for purpose.
The staff at Butterworth Laboratories are experienced in performing method verification for both compendial and supplied client methods.
We will work with you and your company’s requirements, and in accordance with published guidelines, to ensure that an appropriate verification protocol is designed to assess the performance characteristics of a method under the actual conditions of use.
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