ISPE  has published a white paper, "Risk-Based Qualification for the 21st Century,"  to address the challenges of improving and streamlining qualification for cost and time savings, while meeting the new regulatory focus on process understanding and risk mitigation. Authored by a task team appointed by ISPE’s International Leadership Forum, the white paper is a direct response to the FDA’s request for the Society to be a "catalyst for change" in our industry. The FDA has recognized that qualification is an area whose main purpose is often lost: to ensure that equipment is fit for purpose. The FDA is emphasizing quality through systems of quality management, scientific application of process understanding, and controlling risks to the manufacturing process that could impact product quality. 

 Risk-Based Qualification for the 21st Century white paper

For excellent guidance on how to build a focused qualification program, check out ISPE’s Commissioning and Qualification Baseline® Guide.