Analytic method development, validation, and transfer are key elements of any pharmaceutical development program.
Cerbios’ long-term experience in product development and manufacturing is reflected by a straight forward validation strategy to be performed at the right moment of the development
Analytical method validation is the process of demonstrating that an analytical procedure is suitable for its intended purpose. The methodology and objective of the analytical procedures has to be clearly defined and understood before initiating validation studies.
The validation of an analytic method demonstrates the scientific soundness of the measurement or characterization. It is required to varying extents throughout the regulatory submission process.
The path to validation begins in the early phases of drug development as a set of informal experiments that establish the soundness of the method for its intended purpose.
It is expanded in intensity and extent throughout the regulatory submission process into a fully-documented report that is required by NDA submission at Phase III and in support of commercial production.
In order to perform method validation, the QC department is also involved, following written standard operating procedure (SOP) that describes the process of conducting method validation and using qualified and calibrated instrumentation with a corresponding operating SOP.
The service is offered only in connection with the production of pre-clinical, clinical and/or commercial batches.