The last few years have seen several major "names" in drugs and devices stumble over cGMP issues, resulting in multi-million dollar fines, recalls, lawsuits, and even possible criminal prosecution beyond the corporate "veil". This indicates an on-going, major shift in the emphasis of the U.S. FDA cGMP compliance expectations and resulting audits, also affecting clinical trial expectations, product submissions and company response requirements.
This change in focus has a major impact on interpretation of individual compliance objectives, cGMP objectives, and measurements of success. The major failures of key industry "players" in pharmaceuticals, devices, as well as events in unrelated industries have caused the Agency to "get tougher on compliance / enforcement". The cGMP compliance audit, validations, 510(k) submissions / data, "better science", lifecycles, closed-loop CAPA, outsourcing / globalization and supply