Cleaning and cleaning validation rely extensively on the risk assessments and scientific rationales that are prepared for equipment and products. It is imperative to ensure that the scientific rationales that are prepared in support of the cleaning program are identifiable, referenceable, and current. As programs age, it is easy to lose track of the foundational decision-making that guided the initial program. Maintaining scientific rationales as current is a major challenge for many firms as processes and facilities mature.
