Ann Newman - "PAT -; Process Understanding and Control of Active Pharmaceutical Ingredients" S. R. Byrn, J. K. Liang, S. Bates, Ann W. Newman

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      Publication Details (including relevant citation   information):

      Journal of PAT, 2006, 3(6),  14-19.

      Abstract:

     

      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.

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