Common use of Analytical Test Methods Clause in Contracts

Analytical Test Methods. 3 .1 Abbott shall be responsible for demonstrating the validity of all methodology used for in-process control, and release of all materials, Active Compound, components and the Product. This validation, or verification in the case of a compendial raw material item, will be demonstrated. This validation shall be established, through approved protocol and final report, based on the current ICH and FDA validation guidance documents. Method validation shall be performed consistent with Abbott-approved procedures. . Suitability of all compendia methodology will be demonstrated, and written in a report, prior to use for release of materials, Active Compound, components, or the Product(s).