METHOD DEVELOPMENT, QUALIFICATION, AND VALIDATION
We have the necessary equipment and experience to perform validations of analytical methods in any formulation, valuable to reduce the development time required to get you to a validated method. This helps accelerate your product to the marketplace.
Our phase-appropriate validation protocols are developed closely with your goals in mind. Our Standard Operating Procedures for validation methods are modeled after the guidelines in the USP chapter of Validation of Compendial Procedures <1225>. Evaluation of key parameters is essential to a robust validation. Accuracy, precision, specificity, detection limit, quantification limit, linearity, range, and robustness are evaluated in each validation procedure.
Cleaning validations are also critical to remain compliant, especially in a multi-product facility. We have years of experience in cleaning validation and can help on- or off-site for your projects. At completion of any campaign, cleaning verifications are performed on all equipment to ensure the cleanliness and removal of any active ingredient and cleaning agent.
Whether you need validation for your API, in-process, or drug product testing, we are here to provide valuable expertise for your project.