Method Development, Qualification and Validation

Alliance Contract Pharma (ACP) has the necessary equipment and experience to perform validations of analytical methods in any formulation. This valuable experience will reduce your development time required to get to a validated method. This in turn helps accelerate your product to the marketplace.

Our phase appropriate validation protocols are developed closely with the client’s goals in mind. ACP’s Standard Operating Procedures for these validation methods is modeled after the guidelines in USP chapter of Validation of Compendial Procedures <1225>. Evaluation of key parameters are 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 in compliance, especially in a multi – product facility. ACP has 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 major equipment to ensure the cleanliness and removal of any active ingredient or cleaning agent.

Whether you need validation for your API, in-process or drug product testing, ACP is here to provide valuable expertise for your project.