<?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>1729-519X</journal-id>
<journal-title><![CDATA[Revista Habanera de Ciencias Médicas]]></journal-title>
<abbrev-journal-title><![CDATA[Rev haban cienc méd]]></abbrev-journal-title>
<issn>1729-519X</issn>
<publisher>
<publisher-name><![CDATA[Universidad de Ciencias Médicas de la Habana]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S1729-519X2022000500015</article-id>
<title-group>
<article-title xml:lang="es"><![CDATA[La seguridad de las placentas humanas utilizadas como materia prima farmacéutica desde el enfoque bioético]]></article-title>
<article-title xml:lang="en"><![CDATA[Human placenta safety used as pharmaceutical raw material based on the bioethical approach]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Trujillo-Alfonso]]></surname>
<given-names><![CDATA[Maydelín]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Vega-Almeida]]></surname>
<given-names><![CDATA[Rosa Lidia]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Centro de Histoterapia Placentaria (Hisplacen)  ]]></institution>
<addr-line><![CDATA[La Habana ]]></addr-line>
<country>Cuba</country>
</aff>
<aff id="Af2">
<institution><![CDATA[,Grupo Empresarial BioCubaFarma Empresa de Tecnologías de la Información (ETI) ]]></institution>
<addr-line><![CDATA[La Habana ]]></addr-line>
<country>Cuba</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>10</month>
<year>2022</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>10</month>
<year>2022</year>
</pub-date>
<volume>21</volume>
<numero>5</numero>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_arttext&amp;pid=S1729-519X2022000500015&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_abstract&amp;pid=S1729-519X2022000500015&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_pdf&amp;pid=S1729-519X2022000500015&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="es"><p><![CDATA[RESUMEN  Introducción: El uso de la placenta humana como materia prima farmacéutica se debe al contenido de sustancias biológicamente activas. El Centro de Histoterapia Placentaria -HISPLACEN- investiga, desarrolla, produce y comercializa productos de origen placentario.  Objetivo:  Analizar el proceso de aseguramiento y control para certificar la calidad de las placentas humanas como materia prima farmacéutica, desde el enfoque bioético en HISPLACEN.  Material y Métodos:  Se realizó un estudio descriptivo y analítico. Se definió como objeto de investigación: el proceso de aseguramiento y control para certificar la calidad de las placentas humanas en HISPLACEN, y su implantación en el período (2017-2021). Fueron revisados en el estudio, los documentos del Sistema de Gestión de la Calidad institucional, las regulaciones sobre Buenas Prácticas del CECMED, y la literatura científica sobre Bioética.  Resultados: Las etapas del proceso de aseguramiento y control de la calidad para la certificación de las placentas se describieron y analizaron, destacándose la aplicación del enfoque bioético en su implantación. Se identificó la correspondencia de una ética humana y ambientalista de interrelación multidisciplinaria y entre los actores del ecosistema empresarial. Todo ello centrado en las dimensiones relativas a la ciencia y la tecnología para la fabricación de medicamentos.  Conclusiones: Se evidenció el cumplimiento de los principios bioéticos en la certificación de las placentas humanas lo que potenció el desarrollo de un proceso tipificado por la integralidad, funcionalidad, eficacia y robustez. Este órgano biológico empleado como materia prima se abordó desde la multidimensionalidad -científica, tecnológica y bioética- del proceso descrito en sus tres etapas, lo que impacta positivamente, al focalizarse en un objetivo común: garantizar la salud y el bienestar de las personas, unido a la protección medioambiental.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[ABSTRACT  Introduction: The use of human placenta as pharmaceutical raw material is due to the content of biologically active substances. The Placental Histotherapy Center (HISPLACEN) researches, develops, produces, and markets products of placental origin.  Objective:  to analyze the assurance and control process to certify the quality of the human placenta as a raw material in the biopharmaceutical industry, based on the bioethical approach.  Material and Methods:  A descriptive and analytical study was carried out. The process of quality assurance and control of the human placenta in HISPLACEN, and its implementation in the period 2017-2021 was defined as the research object. The documentation of the institutional Quality Management System, Good Practices regulations of the CECMED, and the scientific literature on Bioethics were reviewed.  Results:  The stages of the quality assurance and control of the placenta process and its derived products were described and analyzed, highlighting the application of the bioethical approach in its implementation. The correspondence of a human and environmental ethics of multidisciplinary interrelation and between the actors involved in the entrepreneurial ecosystem was identified. All this focused on the dimensions related to science and technology in the manufacture of medicines.  Conclusions:  The compliance of bioethical principles in the certification of human placentas was evidenced, which promoted the development of a process typified by comprehensiveness, functionality, efficacy, and robustness. This biological organ used as raw material was approached from multidimensionality -scientific, technological and bioethical - of the process focused on a common objective: guaranteeing human health and well-being, together with environmental protection.]]></p></abstract>
<kwd-group>
<kwd lng="es"><![CDATA[Bioética]]></kwd>
<kwd lng="es"><![CDATA[placenta humana]]></kwd>
<kwd lng="es"><![CDATA[aseguramiento de la calidad]]></kwd>
<kwd lng="es"><![CDATA[histoterapia placentaria]]></kwd>
<kwd lng="es"><![CDATA[HISPLACEN]]></kwd>
<kwd lng="es"><![CDATA[BioCubaFarma]]></kwd>
<kwd lng="en"><![CDATA[Bioethics]]></kwd>
<kwd lng="en"><![CDATA[human placenta]]></kwd>
<kwd lng="en"><![CDATA[quality assurance]]></kwd>
<kwd lng="en"><![CDATA[quality control]]></kwd>
<kwd lng="en"><![CDATA[placental histotherapy]]></kwd>
<kwd lng="en"><![CDATA[HISPLACEN]]></kwd>
<kwd lng="en"><![CDATA[BioCubaFarma]]></kwd>
</kwd-group>
</article-meta>
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