{"id":3039,"date":"2023-06-06T08:33:47","date_gmt":"2023-06-06T08:33:47","guid":{"rendered":"https:\/\/divineanalyticalconsultancy.com\/?page_id=3039"},"modified":"2023-08-07T14:51:50","modified_gmt":"2023-08-07T14:51:50","slug":"gap-assessment-glp-audit","status":"publish","type":"page","link":"https:\/\/divineanalyticalconsultancy.com\/index.php\/gap-assessment-glp-audit\/","title":{"rendered":"GAP ASSESSMENT \/ GLP AUDIT"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"3039\" class=\"elementor elementor-3039\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-b7e206b elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"b7e206b\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"aux-parallax-section elementor-column elementor-col-33 elementor-top-column elementor-element elementor-element-548904c\" data-id=\"548904c\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"aux-parallax-section elementor-column elementor-col-33 elementor-top-column elementor-element elementor-element-ea0828e\" data-id=\"ea0828e\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-10b736c elementor-widget elementor-widget-aux_image\" data-id=\"10b736c\" data-element_type=\"widget\" data-widget_type=\"aux_image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<section class=\"widget-container aux-widget-image aux-alignnone aux-parent-au3e5d882f\">\n    <div class=\"aux-media-hint-frame \">\n        <div class=\"aux-media-image \" >\n        \n            \n\n            \n            <img fetchpriority=\"high\" decoding=\"async\" width=\"1814\" height=\"553\" src=\"https:\/\/divineanalyticalconsultancy.com\/wp-content\/uploads\/2023\/06\/GAP-ASSESMENT.jpg\" class=\"aux-attachment aux-featured-image aux-attachment-id-4407 aux-img-dynamic-dropshadow\" alt=\"GAP ASSESMENT\" data-ratio=\"3.28\" data-original-w=\"1814\" \/>            \n                <\/div>\n    <\/div>\n\n<\/section><!-- widget-container -->\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"aux-parallax-section elementor-column elementor-col-33 elementor-top-column elementor-element elementor-element-25c955b\" data-id=\"25c955b\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-340dca4 elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"340dca4\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"aux-parallax-section elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-49dfc8d\" data-id=\"49dfc8d\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-928d387 elementor-widget__width-initial elementor-widget elementor-widget-aux_modern_heading\" data-id=\"928d387\" data-element_type=\"widget\" data-widget_type=\"aux_modern_heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<section class=\"aux-widget-modern-heading\">\n            <div class=\"aux-widget-inner\"><h3 class=\"aux-modern-heading-primary\"><\/h3><div class=\"aux-modern-heading-description\"><ul><li>Audit and confirm compliance of Active substance and starting materials are in line with ICH Q7.\u00a0<\/li><li>Review of OOS\/OOT report and assess the effectiveness of the proposed CAPA<\/li><li>Post approval surveillance audits as per risk assessment. Establish robust key performance index to evaluate, track record and rating for suppliers.<\/li><li>Support Purchase team to evaluate new suppliers.<\/li><li>Support R&amp;D for development of robust API by setting up analytical controls at appropriate stages and in Starting\/raw materials.<\/li><\/ul><\/div><\/div>\n        <\/section>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Audit and confirm compliance of Active substance and starting materials are in line with ICH Q7.\u00a0 Review of OOS\/OOT report and assess the effectiveness of the proposed CAPA Post approval surveillance audits as per risk assessment. Establish robust key performance index to evaluate, track record and rating for suppliers. Support Purchase team to evaluate new [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v20.13 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>GAP ASSESSMENT \/ GLP AUDIT -<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/divineanalyticalconsultancy.com\/index.php\/gap-assessment-glp-audit\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"GAP ASSESSMENT \/ GLP AUDIT -\" \/>\n<meta property=\"og:description\" content=\"Audit and confirm compliance of Active substance and starting materials are in line with ICH Q7.\u00a0 Review of OOS\/OOT report and assess the effectiveness of the proposed CAPA Post approval surveillance audits as per risk assessment. 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