Method Validation

ISO 17025 states: "Validation is the confirmation by examination and the provision of objective evidence that the particular requirements for a specific intended use are fulfilledThe validation shall be extensive as is necessary to meet the needs of the given application".

The ICH guidelines state: "The objective of validation of an analytical procedure is to demonstrate that it is suitable for its intended purpose". In practice, it is usually possible to design the experimental work such that the appropriate validation characteristics can be considered simultaneously to provide a sound, overall knowledge of the capabilities of the analytical procedure".

Unless otherwise agreed with the customer, methods are validated by Butterworth in accordance with the ICH requirements. In addition, the uncertainty of measurement is also calculated as required by ISO17025. Where methods have been developed in-house, the data obtained from the validation process is then used to establish system suitability criteria for the routine application of the method.

Butterworth are happy to validate methods developed in-house, client supplied methods or published methods, such as pharmacopoeia monographs. As with method development, the staff at Butterworth need as much information from our customer as it is reasonably practicable.

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