The impact of continuous manufacturing (CM) on the ability of pharma to fully implement quality by design (QbD) and realize its benefits is becoming clear as the technology moves into full operation. The potential for QbD to come to fruition in the process understanding- and data-rich environment of continuous manufacturing was highlighted by both FDA and industry experts in the discussions at a conference on "Advancing Product Quality," cosponsored by the agency and the Product Quality Research Institute (PQRI) in October in Bethesda, Maryland.
展开▼
