Method Validation


Method Validation

Regulatory agencies expect to see some level of validation for non-compendial methods. Whether your submission is an IND, NDA, IMPD, MAA, CTA, ANDA we can provide the appropriate level of validation for test methods in your CMC section. All relevant guidelines, such as the ICH guidelines are followed.

We typically validate test methods for API, drug products, and drug product containers. The usual validation process involves a validation protocol that is signed by both the client and Pharmaffiliates. We complete the laboratory work in agreement with the protocol made for the test method that is being validated.

We can summarize validation results in the final version of the test method and/or describe the results in detail in a stand-alone validation report. Some typical test method validation parameters are ruggedness, linearity and range, limit of detection and limit of quantitation, accuracy, precision, specificity, robustness and solution stability.

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