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  <front>
    <journal-meta>
      <journal-id journal-id-type="iso-abbrev">Pharmacophore</journal-id>
      <journal-id journal-id-type="publisher-id">pharmacophorejournal.com</journal-id>
      <journal-id journal-id-type="publisher-id">Pharmacophore</journal-id>
      <journal-title-group>
        <journal-title>Pharmacophore</journal-title>
      </journal-title-group>
      <issn pub-type="epub">2229-5402</issn>
    </journal-meta>
    <article-meta>
      <article-id pub-id-type="publisher-id">pharmacophorejournal.com-6985</article-id>
      <article-id pub-id-type="doi">10.51847/seUdqQzQtP</article-id>
      <article-categories>
        <subj-group subj-group-type="heading">
          <subject>Original research</subject>
        </subj-group>
      </article-categories>
      <title-group>
        <article-title>Tanaka Y. Maintaining Pharmaceutical Quality When Algorithms and Processes Change Together: A Lifecycle Framework for Artificial Intelligence–Enabled Process Control, Model Updating, and Knowledge Transfer in Pharmaceutical Manufacturing</article-title>
      </title-group>
                    <contrib-group>
                      <contrib contrib-type="author">
              <name>
                <surname>Chen</surname>
                <given-names>David</given-names>
              </name>
                              <xref rid="aff1" ref-type="aff">1</xref>
                                                            <xref rid="cor1" ref-type="corresp" />
                          </contrib>
                      <contrib contrib-type="author">
              <name>
                <surname>Papadopoulou</surname>
                <given-names>Maria</given-names>
              </name>
                              <xref rid="aff2" ref-type="aff">2</xref>
                                        </contrib>
                      <contrib contrib-type="author">
              <name>
                <surname>Boateng</surname>
                <given-names>Kwame</given-names>
              </name>
                              <xref rid="aff3" ref-type="aff">3</xref>
                                        </contrib>
                      <contrib contrib-type="author">
              <name>
                <surname>Tanaka</surname>
                <given-names>Yuki</given-names>
              </name>
                              <xref rid="aff4" ref-type="aff">4</xref>
                                        </contrib>
                  </contrib-group>
                  <aff id="aff1">
            <label>1</label>Department of Pharmaceutical Manufacturing and AI Process Control, National University of Singapore, Singapore.
          </aff>
                  <aff id="aff2">
            <label>2</label>Department of Quality Assurance and Pharmaceutical Engineering, Athens University of Economics and Business, Athens, Greece.
          </aff>
                  <aff id="aff3">
            <label>3</label>Department of Pharmaceutical Quality and Regulatory Science, University of Ghana, Accra, Ghana.
          </aff>
                  <aff id="aff4">
            <label>4</label>Department of Pharmaceutical Engineering and Smart Manufacturing, Waseda University, Tokyo, Japan.
          </aff>
                          <author-notes>
            <corresp id="cor1">
              <bold>Address for correspondence:</bold> Prof. Wael Abu Dayyih, Department of
              Pharmaceutical Chemistry, Faculty of Pharmacy, Mutah University, Al-Karak 61710, Jordan.
                              E-mail: <email xlink:href="david.chen@nus.edu.sg">david.chen@nus.edu.sg</email>
                          </corresp>
          </author-notes>
                    <pub-date pub-type="epub">
        <day>28</day>
        <month>10</month>
        <year>2026</year>
      </pub-date>
      <volume>17</volume>
      <issue>5</issue>
      <fpage>26</fpage>
      <lpage>35</lpage>
      <permissions>
        <copyright-statement>
          Copyright: &#x000a9; 2026 Pharmacophore
        </copyright-statement>
        <copyright-year>2026</copyright-year>
        <license>
          <ali:license_ref xmlns:ali="http://www.niso.org/schemas/ali/1.0/"
            specific-use="textmining" content-type="ccbyncsalicense">
            https://creativecommons.org/licenses/by-nc-sa/4.0/</ali:license_ref>
          <license-p>This is an open access journal, and articles are distributed under the terms of
            the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows
            others to remix, tweak, and build upon the work non-commercially, as long as appropriate
            credit is given and the new creations are licensed under the identical terms.</license-p>
        </license>
      </permissions>
      <abstract>
        <title>A<sc>BSTRACT</sc></title>
        <p>Artificial intelligence is entering pharmaceutical manufacturing through process models, soft sensors, adaptive process analytical technologies, digital twins, and increasingly direct links to advanced process control. These applications create a lifecycle problem that is insufficiently described when manufacturing-process change and algorithmic change are governed as separate maintenance events. A process may move beyond the conditions under which a model was calibrated or validated even when the algorithm itself is unchanged, while a model update may alter state estimation, predicted quality attributes, diversion decisions, or control actions despite unchanged equipment. This article develops a lifecycle account of pharmaceutical quality under such coupled change. It synthesizes evidence from continuous manufacturing, process analytical technology, digital twins, model-predictive control, machine-learning process models, and quality-system digitalization to examine how model applicability, measurement validity, control meaning, validation status, and process knowledge evolve together. The central argument is that the relevant object of lifecycle governance is the joint process–model state: the combination of the physical manufacturing condition, analytical interface, data lineage, model version, applicability domain, control linkage, and evidence supporting quality-relevant decisions.  Quality is threatened when one component changes while the others are treated as stationary. The framework therefore treats revalidation and comparability as impact-based questions concerning whether a transition changes a quality-critical inference, action, or evidentiary assumption.  This approach also makes knowledge transfer a quality function because process engineers, data scientists, quality units, and regulatory actors must preserve the reasoning that connects process evidence to model behavior and product disposition.</p>
      </abstract>
      <kwd-group>
                <kwd>Artificial intelligence</kwd>
                <kwd>Pharmaceutical manufacturing</kwd>
                <kwd>Process control</kwd>
                <kwd>Model lifecycle management</kwd>
                <kwd>Process analytical technology</kwd>
                <kwd>Knowledge transfer</kwd>
              </kwd-group>
    </article-meta>
  </front>
</article>
