Sufficient Evidence

摘要

Quality professionals make decisions based on evidence that is reliable, relevant and sufficient. The International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH Q9 guide provides guidance for applying quality risk management to supplier evaluation systems. With regard to the consideration of sufficient audit evidence, it may be helpful to begin with the evaluation of a contract manufacturing organization (CMO). For many organizations, a CMO supplier may represent the greater risk and challenge for obtaining sufficient evidence. You begin managing risk by identifying and documenting your quality requirements and clearly communicating them to the supplier.