<?xml version="1.0" encoding="ISO-8859-1"?><article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance">
<front>
<journal-meta>
<journal-id>1815-5936</journal-id>
<journal-title><![CDATA[Ingeniería Industrial]]></journal-title>
<abbrev-journal-title><![CDATA[Ing. Ind.]]></abbrev-journal-title>
<issn>1815-5936</issn>
<publisher>
<publisher-name><![CDATA[Facultad de Ingeniería Industrial, Instituto Superior Politécnico José Antonio Echeverría, Cujae.]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S1815-59362021000100029</article-id>
<title-group>
<article-title xml:lang="es"><![CDATA[Sistema de Validación para el proceso de fabricación del Ingrediente Farmacéutico Activo Furvina]]></article-title>
<article-title xml:lang="en"><![CDATA[Validation System for the manufacturing process of the Active Pharmaceutical Ingredient Furvina]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Alonso-Rodríguez]]></surname>
<given-names><![CDATA[Heidy L]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Cuellar-de la Cruz]]></surname>
<given-names><![CDATA[Mirta E.]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Calvo-Alonso]]></surname>
<given-names><![CDATA[Amalia M.]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Universidad Central &#8220;Marta Abreu&#8221; de Las Villas  ]]></institution>
<addr-line><![CDATA[Villa Clara ]]></addr-line>
<country>Cuba</country>
</aff>
<aff id="Af2">
<institution><![CDATA[,Instituto Superior de Ingeniería Mecánica Automotriz  ]]></institution>
<addr-line><![CDATA[Toluca de Lerdo ]]></addr-line>
<country>México</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>04</month>
<year>2021</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>04</month>
<year>2021</year>
</pub-date>
<volume>42</volume>
<numero>1</numero>
<fpage>29</fpage>
<lpage>49</lpage>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_arttext&amp;pid=S1815-59362021000100029&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_abstract&amp;pid=S1815-59362021000100029&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_pdf&amp;pid=S1815-59362021000100029&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="es"><p><![CDATA[RESUMEN En este trabajo se diseñó un Sistema de Validación para el proceso de fabricación del Ingrediente Farmacéutico Activo, Furvina, obtenido a partir de síntesis química en la planta de producción del Centro de Bioactivos Químicos. Para lograr este objetivo y tener un conocimiento previo de dicho proceso de fabricación, se confeccionaron los diagramas de flujo de los procesos de producción y control de la calidad. Se realizó un diagnóstico sobre el estado de los estudios de validación. Se hizo una planeación del sistema a través del análisis 5W y H (what, why, when, where, who y how) y se confeccionó un procedimiento para identificar los objetos a validar en la fabricación de la Furvina. Como principales resultados se obtuvieron el sistema de validación para el proceso de fabricación de la Furvina y una metodología para realizar los estudios de validación, basada en el ciclo Deming (planificar- hacer-verificar-actuar).]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[ABSTRACT In this work, a Validation System was designed for the manufacturing process of the Active Pharmaceutical Ingredient, Furvina, obtained from chemical synthesis in the production plant of the Center for Chemical Bioactives. To achieve this objective and have a prior knowledge of that manufacturing process, the flowcharts of the production and quality control processes were prepared. A diagnosis was made on the status of the validation studies. A system planning was carried out through the 5W and H analysis and a procedure was prepared to identify the objects to be validated in the Furvina manufacturing. The main results were the validation system for the Furvina manufacturing process and a methodology to carry out the validation studies, based on the Deming cycle (plan-do-verify-act).]]></p></abstract>
<kwd-group>
<kwd lng="es"><![CDATA[sistema]]></kwd>
<kwd lng="es"><![CDATA[validación]]></kwd>
<kwd lng="es"><![CDATA[ingrediente farmacéutico activo]]></kwd>
<kwd lng="en"><![CDATA[System]]></kwd>
<kwd lng="en"><![CDATA[Validation]]></kwd>
<kwd lng="en"><![CDATA[Active Pharmaceutical Ingredient]]></kwd>
</kwd-group>
</article-meta>
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