{"id":27171,"date":"2021-04-23T07:43:46","date_gmt":"2021-04-23T05:43:46","guid":{"rendered":"http:\/\/newwebir.recercasantpau.cat\/en\/?page_id=27171"},"modified":"2025-05-23T10:35:56","modified_gmt":"2025-05-23T08:35:56","slug":"quality-unit","status":"publish","type":"page","link":"https:\/\/www.recercasantpau.cat\/en\/support-services\/quality-unit\/","title":{"rendered":"Quality Assurance Unit (QA)"},"content":{"rendered":"<h3><img loading=\"lazy\" decoding=\"async\" class=\"alignnone  wp-image-55618\" src=\"https:\/\/www.recercasantpau.cat\/wp-content\/uploads\/2025\/05\/foto-qa-web_-1-300x182.png\" alt=\"\" width=\"402\" height=\"244\" srcset=\"https:\/\/www.recercasantpau.cat\/wp-content\/uploads\/2025\/05\/foto-qa-web_-1-300x182.png 300w, https:\/\/www.recercasantpau.cat\/wp-content\/uploads\/2025\/05\/foto-qa-web_-1-768x465.png 768w, https:\/\/www.recercasantpau.cat\/wp-content\/uploads\/2025\/05\/foto-qa-web_-1-580x351.png 580w, https:\/\/www.recercasantpau.cat\/wp-content\/uploads\/2025\/05\/foto-qa-web_-1.png 925w\" sizes=\"auto, (max-width: 402px) 100vw, 402px\" \/><\/h3>\n<h3><\/h3>\n<h3>Coordinator<\/h3>\n<p>Marta Mitj\u00e0 Ventura<br \/>\n<a href=\"mailto:mmitja@santpau.cat\">mmitja@santpau.cat<\/a><\/p>\n<h3>Team<\/h3>\n<p>Mar\u00eda Guadalupe Franco<\/p>\n<p>Javier Ferrando Mart\u00ednez<\/p>\n<h3>Functions<\/h3>\n<p>Establish mechanisms to assess Quality and Best Scientific Practices at IIB\u00a0Sant Pau, promoting continuous improvement and excellence goals.<\/p>\n<p>Establishment and monitoring of IIB\u00a0Sant Pau\u2019s Quality Assurance Program.<\/p>\n<p>Implement and follow-up of the Integrated Management System, including the establishment of improvement policies under the following standards:<\/p>\n<ul>\n<li>Good Manufacturing Practices, specific to Advanced Therapy Medicinal Products, at the Clean Room.<\/li>\n<li>Good Clinical Practices, at CIM Sant Pau Phase I Unit<\/li>\n<li>Good Clinical Practices, at Medical Oncology Phase I Unit.<\/li>\n<li>ISO 9001, Quality Management System, at Scientific and Technical Services.<\/li>\n<li>UNE 166002, R+D+i Management System, at Innovation and Transference Unit.<\/li>\n<li>Good Laboratory Practices.<\/li>\n<\/ul>\n<p>Quality Management in the different stages of Advanced Therapy Medicinal Product\u2019s production.<\/p>\n<p><a href=\"https:\/\/www.recercasantpau.cat\/en\/the-institute\/corporate-information\/certifications-of-the-institute\/\" target=\"_blank\" rel=\"noopener\">Certification link<\/a><\/p>\n<p>Perform internal audits:<\/p>\n<ul>\n<li>Batch documentation of Advanced Therapy Medicinal Products.<\/li>\n<li>Clinical Trial protocols, data bases, experimental phases, installations, processes and final reports.<\/li>\n<li>Scientific and Technical Services.<\/li>\n<li>Suppliers.<\/li>\n<\/ul>\n<p>Coordinate, oversee and follow up of the external\u00a0Inspections \/audits from:<\/p>\n<ul>\n<li>Public Administration (ex: Generalitat, Espa\u00f1ola de Medicamentos y Productos Sanitarios &#8230;).<\/li>\n<li>Clinical Trial Promoters.<\/li>\n<li>Certification Entities.<\/li>\n<\/ul>\n<p>Provide support for\u00a0Quality Management System\u2019s design and implementation in other areas.<\/p>\n<p>Coordinate the ISO\u00a0Quality Committee and the Good Manufacturing Practices Committee.<\/p>\n<p>Provide support at design stage of the new IR-HSCSP Clean Room.<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Coordinator Marta Mitj\u00e0 Ventura mmitja@santpau.cat Team Mar\u00eda Guadalupe Franco Javier Ferrando Mart\u00ednez Functions Establish mechanisms to assess Quality and Best Scientific Practices at IIB\u00a0Sant Pau, promoting continuous improvement and excellence goals. Establishment and monitoring of IIB\u00a0Sant Pau\u2019s Quality Assurance Program. Implement and follow-up of the Integrated Management System, including the establishment of improvement policies under &#8230; <br \/><a class=\"read-more\" href=\"https:\/\/www.recercasantpau.cat\/en\/support-services\/quality-unit\/\">Read More<\/a><\/p>\n","protected":false},"author":10,"featured_media":3580,"parent":3996,"menu_order":6,"comment_status":"closed","ping_status":"closed","template":"template-serveis.php","meta":{"footnotes":""},"class_list":["post-27171","page","type-page","status-publish","has-post-thumbnail","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.recercasantpau.cat\/en\/wp-json\/wp\/v2\/pages\/27171","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.recercasantpau.cat\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.recercasantpau.cat\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.recercasantpau.cat\/en\/wp-json\/wp\/v2\/users\/10"}],"replies":[{"embeddable":true,"href":"https:\/\/www.recercasantpau.cat\/en\/wp-json\/wp\/v2\/comments?post=27171"}],"version-history":[{"count":18,"href":"https:\/\/www.recercasantpau.cat\/en\/wp-json\/wp\/v2\/pages\/27171\/revisions"}],"predecessor-version":[{"id":55621,"href":"https:\/\/www.recercasantpau.cat\/en\/wp-json\/wp\/v2\/pages\/27171\/revisions\/55621"}],"up":[{"embeddable":true,"href":"https:\/\/www.recercasantpau.cat\/en\/wp-json\/wp\/v2\/pages\/3996"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.recercasantpau.cat\/en\/wp-json\/wp\/v2\/media\/3580"}],"wp:attachment":[{"href":"https:\/\/www.recercasantpau.cat\/en\/wp-json\/wp\/v2\/media?parent=27171"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}