Weaving the Qualification Maze and Why should Consumers care

This is a great topic discussing FDA requirements for method, process and equipment qualification in pharmaceutical and neutriceutical manufacturing. Safeguards and parameters established during these studies are key for ensuring sound and reproducible manufacturing and testing processes. But FDA has deliberately left the definition of these steps vague, instead leaving it to the industries to define it in their own terms. Is this the best approach to safeguard publich health?