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 purposeIn 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".
Typical validation characteristics are:
- Accuracy
- Precision
- Specificity
- Detection limit
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- Quantitation limit
- Linearity
- Range
- Robustness
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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. A checklist is supplied to assist with the collection of this information:
- Reason for method to be validated
- Customer experience of the method
- Type/ range of sample(s) to be tested
- Type of analytical procedure
- Identification
- Testing for impurities - quantitative or limit
- Assay - content/ potency or dissolution
- Stability indicating
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- Hazards associated with sample(s)
- Parameter(s) to be addressed in validation plan
- Specific customer in-house QC requirements
- Reference standards available/ required
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Butterworth Laboratories have the relevant facilities to undertake stress testing as outlined in the relevant ICH guidelines for the development of stability indicating methods.
Following development of a method, prior to analysing samples the laboratory, we require the method to be validated to a level agreed with the client.
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