Publication Details (including relevant citation information):
Journal of PAT, 2006, 3(6), 14-19.
Active pharmaceutical ingredients (APIs) are a key input variable for the drug product. Unquestionably, the control of API chemical and physical quality is paramount to product performance. Historically, API production implements the quality-by-testing (QbT) approach that involves the manufacture of the product using batch processes, followed by laboratory testing and analysis to verify its quality and rejecting those lots that fail to meet its stated specification. This approach results in a great deal of waste and thus is costly to the manufacturer and in turn the consumer. In August 2002, the FDA announced a significant new initiative, Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century. This risk-based quality review and assessment system is intended to ensure the risk is mitigated while facilitating innovation and continuous improvement. Since quality cannot be tested into products, the FDA is looking specifically at the quality-by-design approach (QbD), which shifts the emphasis from testing the final product to building quality into the manufacturing process from the beginning.