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.