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Tags: Risk analysis

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  1. USP's first TG - Control Strategies for Solid Oral Drug Product

    Forum › defaultsection › technical-guides

    USP is excited to share our first technical guide (TG) on PCM, focusing on solid oral drug product manufacturing control strategies. As we all know, the concept of control strategy is well...

    https://cmkc.usp.org/forum/defaultsection/technical-guides/69

  2. A Systematic Framework for Process Control Design and Risk Analysis in Continuous Pharmaceutical Solid-Dosage Manufacturing

    09 Jun 2023 | Contributor(s):: Su, Qinglin, Moreno, Mariana, Giridhar, Arun, Reklaitis, Gintaras, Nagy, Zoltan

    The paradigm shift in the pharmaceutical industry to continuous manufacturing, which has recently progressed from conceptual demonstration to pilot production, has stimulated the development and application of process systems engineering (PSE) tools for implementing efficient and robust control...