{"id":89043,"date":"2023-10-24T15:12:57","date_gmt":"2023-10-24T08:12:57","guid":{"rendered":"https:\/\/techmaster.com.vn\/?page_id=89043"},"modified":"2023-10-24T15:12:57","modified_gmt":"2023-10-24T08:12:57","slug":"contamination-control-strategies-for-innovation-and-regulatory-compliance","status":"publish","type":"page","link":"https:\/\/techmaster.com.vn\/en\/contamination-control-strategies-for-innovation-and-regulatory-compliance\/","title":{"rendered":"Contamination Control Strategies for Innovation and Regulatory Compliance"},"content":{"rendered":" \t<section class=\"section\" id=\"section_443400774\">\n\t\t<div class=\"bg section-bg fill bg-fill  \" >\n\n\t\t\t\n\t\t\t\n\t\t\t\n\n\t\t<\/div>\n\n\t\t\n\n\t\t<div class=\"section-content relative\">\n\t\t\t <div class=\"row\"  id=\"row-297009525\"> \n\t<div id=\"col-801314594\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t \t<div id=\"text-3908019212\" class=\"text\">\n\t\t\r\n<h1 class=\"text-light\">Contamination Control Strategies for Innovation and <br \/>Regulatory Compliance<\/h1>\r\n\t\t\n<style>\n#text-3908019212 {\n  font-size: 1.5rem;\n  line-height: 1.2;\n  color: rgb(255,255,255);\n}\n#text-3908019212 > * {\n  color: rgb(255,255,255);\n}\n<\/style>\n\t<\/div>\n\t \t\t<\/div>\n\t\t\t\t\n<style>\n#col-801314594 > .col-inner {\n  padding: 0px 0px 0px 20px;\n  margin: -4px 0px -55px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t <\/div> \t\t<\/div>\n\n\t\t\n<style>\n#section_443400774 {\n  padding-top: 30px;\n  padding-bottom: 30px;\n}\n#section_443400774 .section-bg.bg-loaded {\n  background-image: url(https:\/\/techmaster.com.vn\/wp-content\/uploads\/2023\/06\/microbial-product-banners.jpg);\n}\n#section_443400774 .ux-shape-divider--top svg {\n  height: 150px;\n  --divider-top-width: 100%;\n}\n#section_443400774 .ux-shape-divider--bottom svg {\n  height: 150px;\n  --divider-width: 100%;\n}\n<\/style>\n\t<\/section>\n\t \t<section class=\"section\" id=\"section_1534543988\">\n\t\t<div class=\"bg section-bg fill bg-fill  bg-loaded\" >\n\n\t\t\t\n\t\t\t\n\t\t\t\n\n\t\t<\/div>\n\n\t\t\n\n\t\t<div class=\"section-content relative\">\n\t\t\t <div class=\"row\"  id=\"row-1265862808\"> \n\t<div id=\"col-1449816222\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\r\n<p>A Contamination Control Strategy (CCS) outlines a method to identify and analyze risk, review the mitigating opportunities and innovations, and ultimately define corrective and preventive action plans. Implementation of a CCS attempts to address the varied causes of contamination and compromised sterility.<\/p>\r\n<p>This paper addresses The 3 Steps of Developing a CCS: Assessment, Acceptance, and Remediation.<\/p>\r\n<ol>\r\n<li>Assessment: Outline the CCS<\/li>\r\n<li>\u00a0Acceptance: Compilation of CCS Documentation<\/li>\r\n<li>Remediation: CCS Evaluation<\/li>\r\n<\/ol>\r\n<p>Execution of a robust Contamination Control Strategy needs the support of subject matter experts in Manufacturing, Regulatory, Quality Control, Quality Assurance, and supporting departments.<\/p>\r\n<h2>Development of a CCS<a href=\"https:\/\/techmaster.com.vn\/wp-content\/uploads\/2023\/10\/contamination-control-strategies-for-innovation-and-regulatory-compliance.jpg\"><img loading=\"lazy\" decoding=\"async\" class=\"alignright wp-image-89045\" src=\"https:\/\/techmaster.com.vn\/wp-content\/uploads\/2023\/10\/contamination-control-strategies-for-innovation-and-regulatory-compliance.jpg\" alt=\"Contamination control strategies for innovation and regulatory compliance\" width=\"350\" height=\"350\" \/><\/a><\/h2>\r\n<p>The proposed elements to be considered for the CCS are listed in Annex 1:<\/p>\r\n<p><em>\u201c2.5 The development of the CCS requires detailed technical and process knowledge. Potential sources of contamination are attributable to microbial and cellular debris (e.g. pyrogen, endotoxin) as well as particulate (e.g. glass and other visible and sub-visible particles).<\/em><\/p>\r\n<p><em>Elements to be considered within a CCS should include (but are not limited to):<\/em><\/p>\r\n<p>i. Design of both the plant and processes including the associated documentation.<br \/>ii. Premises and equipment.<br \/>iii. Personnel.<br \/>iv. Utilities.<br \/>v. Raw material controls \u2013 including in-process controls.<br \/>vi. Product containers and closures.<br \/>vii. Vendor \u2026.<\/p>\r\n<p style=\"text-align: center;\"><span style=\"font-size: 110%;\"><strong>Interested in learning more? Complete the form <span style=\"text-decoration: underline;\"><em><a href=\"https:\/\/techmaster.com.vn\/en\/contact\/#request\">here<\/a><\/em><\/span> to receive expert consultation.<\/strong><\/span><\/p>\r\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1449816222 > .col-inner {\n  padding: 0px 0px 0px 20px;\n}\n<\/style>\n\t<\/div>\n\n\t <\/div> \t\t<\/div>\n\n\t\t\n<style>\n#section_1534543988 {\n  padding-top: 30px;\n  padding-bottom: 30px;\n  background-color: rgb(255,255,255);\n}\n#section_1534543988 .ux-shape-divider--top svg {\n  height: 150px;\n  --divider-top-width: 100%;\n}\n#section_1534543988 .ux-shape-divider--bottom svg {\n  height: 150px;\n  --divider-width: 100%;\n}\n<\/style>\n\t<\/section>\n\t ","protected":false},"excerpt":{"rendered":"","protected":false},"author":176,"featured_media":89073,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"page-blank.php","meta":{"footnotes":""},"class_list":["post-89043","page","type-page","status-publish","has-post-thumbnail","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.8 (Yoast SEO v26.8) - 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