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Analytical method validation is a process of performing several tests designed to verify that an analytical test system is suitable for its intended purpose and is capable of providing useful and valid analytical data. A validation study involves testing multiple attributes of a method to determine that it can provide useful and valid data when used routinely.
To accurately assess method parameters, the validation test must include normal test conditions, such as product excipients. Therefore, a method validation study is product-specific.
A method validation study requires:
Established method requirements
- Establishing firm requirements is a critical first step is study design. The purpose of the method must be understood, and the accuracy limits must be set.
Well-characterized reference materials
- These may include reference standards, placebo and/or individual excipients, or samples with known concentrations. ASI can provide some of these materials, but some may be required from the client.
A method suitable for the intended purpose
- A method that has previously been used may be provided and validated during this process, or a new method may be developed before the validation process starts. Method development activities are separate from a validation study.
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