{"id":369,"date":"2022-12-29T13:16:57","date_gmt":"2022-12-29T18:16:57","guid":{"rendered":"https:\/\/mivado.com\/mgp\/?page_id=369"},"modified":"2025-08-14T18:44:26","modified_gmt":"2025-08-14T22:44:26","slug":"gxp-compliance-auditing","status":"publish","type":"page","link":"https:\/\/mivado.com\/mgp\/solutions\/gxp-compliance-auditing\/","title":{"rendered":"GxP Compliance Auditing"},"content":{"rendered":"<div class=\"wpb-content-wrapper\"><p>[vc_row][vc_column width=&#8221;1\/2&#8243;][vc_column_text css=&#8221;&#8221;]<\/p>\r\n<p>It is a systematic, independent, and documented process for obtaining and objectively evaluating evidence to determine the extent to which audit criteria are met. The goal is to confirm that your supplier&#8217;s quality system is in place and effective, guaranteeing the quality of services and products.<\/p>\r\n<!-- \/wp:post-content -->\r\n<p><!-- wp:paragraph -->Our audit processes are highly structured, with a built-in qualitative or quantitative rating system. We can assess all aspects of your quality management program, including GxP requirements. At the initial consultation, we form an accurate understanding of your business, what you require, and what needs to be done. So, our intervention is tailored to your specific needs.<\/p>\r\n<p>[\/vc_column_text][\/vc_column][vc_column width=&#8221;1\/2&#8243;][vc_single_image image=&#8221;3851&#8243; img_size=&#8221;Large&#8221; alignment=&#8221;center&#8221; style=&#8221;vc_box_rounded&#8221; css=&#8221;&#8221;][\/vc_column][\/vc_row][vc_row][vc_column][vc_custom_heading text=&#8221;GxP System Auditing&#8221; css=&#8221;&#8221;][vc_empty_space][vc_column_text css=&#8221;&#8221;]<\/p>\r\n<p>Mivado Globalperformance can help you build a successful, resilient business in compliance with GxP requirements. Don\u2019t worry! Our auditors\u2019 in-depth knowledge of domestic and international regulations, combined with their hands-on GxP experience, can help alleviate the uncertainty associated with GMP compliance.<\/p>\r\n<!-- \/wp:paragraph -->\r\n<p><!-- wp:paragraph -->Mivado GlobalPerformance provides the following audit activities:<\/p>\r\n<p>[\/vc_column_text][\/vc_column][\/vc_row][vc_row css=&#8221;.vc_custom_1755206697011{background-color: #F6F4F4 !important;}&#8221;][vc_column width=&#8221;1\/4&#8243;][vc_custom_heading text=&#8221;Quality System Auditing&#8221; css=&#8221;&#8221;][vc_empty_space][vc_column_text css=&#8221;&#8221;]<\/p>\r\n<ul>\r\n<li>QMS Implementation Support<\/li>\r\n<li>Review Quality Systems components,<\/li>\r\n<li>Evaluate suppliers of raw materials, packaging and labeling components, and distribution of clinical trial materials<\/li>\r\n<li>Review CAPA programs<\/li>\r\n<li>Method validations (analytical and microbiological)<\/li>\r\n<li>Review submitted method validations<\/li>\r\n<li>Review Validation Package<\/li>\r\n<\/ul>\r\n<p>[\/vc_column_text][\/vc_column][vc_column width=&#8221;1\/4&#8243;][vc_custom_heading text=&#8221;Facility Compliance&#8221; css=&#8221;&#8221;][vc_empty_space][vc_column_text css=&#8221;&#8221;]<\/p>\r\n<ul>\r\n<li>Facility, Utilities, Equipment &amp; Systems Audit<\/li>\r\n<li>GMP Documentation Review<\/li>\r\n<li>Laboratory, Methods &amp; Specifications<\/li>\r\n<li>CAPA programs (Corrective Action\/ Preventive Action)<\/li>\r\n<li>Review Validation Lifecycle<\/li>\r\n<li>Assess Vendor Certification Programs<\/li>\r\n<li>Evaluate data integrity<\/li>\r\n<\/ul>\r\n<p>[\/vc_column_text][\/vc_column][vc_column width=&#8221;1\/4&#8243;][vc_custom_heading text=&#8221;Vendor GMP Audits&#8221; css=&#8221;&#8221;][vc_empty_space][vc_column_text css=&#8221;&#8221;]<\/p>\r\n<ul>\r\n<li>Perform routine and qualification audits<\/li>\r\n<li>Laboratories and suppliers of drug substance, raw materials, and packaging components<\/li>\r\n<li>Inspect facilities and equipment<\/li>\r\n<li>Assess the qualification and training of personnel<\/li>\r\n<li>Review the organization&#8217;s structure<\/li>\r\n<li>Assess Quality Systems and CGMP compliance<\/li>\r\n<\/ul>\r\n<p>[\/vc_column_text][\/vc_column][vc_column width=&#8221;1\/4&#8243;][vc_custom_heading text=&#8221;Inspection Readiness&#8221; css=&#8221;&#8221;][vc_empty_space][vc_column_text css=&#8221;&#8221;]<\/p>\r\n<ul>\r\n<li>Evaluate the preparedness of manufacturing facilities<\/li>\r\n<li>Assess the readiness of site personnel<\/li>\r\n<li>Prepare personnel for inspector interviews<\/li>\r\n<li>Review Chemistry, Manufacturing, and Control (CMC) submissions<\/li>\r\n<li>Assess technical transfer for manufacturing and test methods<\/li>\r\n<li>Review labeling for compliance<\/li>\r\n<\/ul>\r\n<p>[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column][vc_column_text css=&#8221;&#8221;]<\/p>\r\n<p>I am text block. Click edit button to change this text. Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo.<\/p>\r\n<p>[\/vc_column_text][vc_custom_heading text=&#8221;IT infrastructure and IT operation Inspection Readiness&#8221; css=&#8221;&#8221;][vc_column_text css=&#8221;&#8221;]<\/p>\r\n<p>Professional services for GMP (Good Manufacturing Practice) IT infrastructure and IT operation audits are essential for life sciences and regulated industries where data integrity, product quality, and regulatory compliance are critical.<\/p>\r\n<p>[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column][vc_empty_space][vc_column_text css=&#8221;&#8221;]<\/p>\r\n<div class=\"wp-block-columns\">\r\n<div class=\"wp-block-column\">\r\n<p><a class=\"wp-block-button__link has-luminous-vivid-amber-background-color has-background wp-element-button\" style=\"border-radius: 18px;\" href=\"https:\/\/mivado.com\/mgp\/contact\/\">Send a request now!<\/a><\/p>\r\n<\/div>\r\n<\/div>\r\n<div class=\"wp-block-buttons\"><!-- \/wp:paragraph --><\/div>\r\n<!-- \/wp:buttons -->\r\n<!-- wp:block {\"ref\":422} \/-->\r\n<!-- wp:spacer {\"height\":\"33px\"} -->\r\n<div class=\"wp-block-spacer\" style=\"height: 33px;\" aria-hidden=\"true\"><\/div>\r\n<!-- \/wp:spacer -->\r\n<!-- wp:heading -->\r\n<h2 class=\"wp-block-heading\">Awards &amp; Certifications<\/h2>\r\n<!-- \/wp:heading -->\r\n<!-- wp:columns -->\r\n<div class=\"wp-block-columns\"><!-- wp:column -->\r\n<div class=\"wp-block-column\"><!-- wp:image {\"lightbox\":{\"enabled\":false},\"id\":1859,\"width\":\"200px\",\"height\":\"200px\",\"scale\":\"contain\",\"sizeSlug\":\"thumbnail\",\"linkDestination\":\"custom\"} -->\r\n<figure class=\"wp-block-image size-thumbnail is-resized\"><a href=\"https:\/\/mivado.com\/mgp\/pressrelease\/mivado-globalperformance-wins-top-pharmaceutical-consultant-award-2024\/\"><img loading=\"lazy\" decoding=\"async\" width=\"624\" height=\"624\" class=\"wp-image-1859\" style=\"object-fit: contain; width: 200px; height: 200px;\" src=\"https:\/\/i0.wp.com\/mivado.com\/mgp\/wp-content\/uploads\/2024\/05\/badge_qualio-pharma-2024-1.png?resize=150%2C150&amp;ssl=1\" alt=\"\" srcset=\"https:\/\/i0.wp.com\/mivado.com\/mgp\/wp-content\/uploads\/2024\/05\/badge_qualio-pharma-2024-1.png?w=624&amp;ssl=1 624w, https:\/\/i0.wp.com\/mivado.com\/mgp\/wp-content\/uploads\/2024\/05\/badge_qualio-pharma-2024-1.png?resize=300%2C300&amp;ssl=1 300w, https:\/\/i0.wp.com\/mivado.com\/mgp\/wp-content\/uploads\/2024\/05\/badge_qualio-pharma-2024-1.png?resize=150%2C150&amp;ssl=1 150w\" sizes=\"auto, (max-width: 624px) 100vw, 624px\" \/><\/a><\/figure>\r\n<!-- \/wp:image -->\r\n<\/div>\r\n<p><!-- \/wp:column --><br \/>\r\n<!-- wp:column --><\/p>\r\n<div class=\"wp-block-column\"><\/div>\r\n<p><!-- \/wp:column --><br \/>\r\n<!-- wp:column --><\/p>\r\n<div class=\"wp-block-column\"><\/div>\r\n<!-- \/wp:column -->\r\n<\/div>\r\n<p><!-- \/wp:columns -->[\/vc_column_text][\/vc_column][\/vc_row]<\/p>\r\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_row][vc_column width=&#8221;1\/2&#8243;][vc_column_text css=&#8221;&#8221;] It is a systematic, independent, and documented process for obtaining and objectively evaluating evidence to determine the extent to which audit criteria are met. The goal is to confirm that your supplier&#8217;s quality system is in place and effective, guaranteeing the quality of services and products. Our audit processes are highly structured,<\/p>\n<div class=\"clearfix\"><\/div>\n<div class=\"pull-left padding-top-25\"><a href=\"https:\/\/mivado.com\/mgp\/solutions\/gxp-compliance-auditing\/\" class=\"btn btn-theme\">Continue Reading <span class=\"screen-reader-text\"> &#8220;GxP Compliance Auditing&#8221;<\/span> <i class=\"fa fa-fw fa-long-arrow-right\"><\/i> <\/a>  <\/div>\n","protected":false},"author":1,"featured_media":0,"parent":184,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"template\/full-container.php","meta":{"footnotes":""},"class_list":["post-369","page","type-page","status-publish","hentry"],"wps_subtitle":"Building a successful, resilience business in compliance with GxP requirements","_links":{"self":[{"href":"https:\/\/mivado.com\/mgp\/wp-json\/wp\/v2\/pages\/369","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mivado.com\/mgp\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/mivado.com\/mgp\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/mivado.com\/mgp\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/mivado.com\/mgp\/wp-json\/wp\/v2\/comments?post=369"}],"version-history":[{"count":22,"href":"https:\/\/mivado.com\/mgp\/wp-json\/wp\/v2\/pages\/369\/revisions"}],"predecessor-version":[{"id":3867,"href":"https:\/\/mivado.com\/mgp\/wp-json\/wp\/v2\/pages\/369\/revisions\/3867"}],"up":[{"embeddable":true,"href":"https:\/\/mivado.com\/mgp\/wp-json\/wp\/v2\/pages\/184"}],"wp:attachment":[{"href":"https:\/\/mivado.com\/mgp\/wp-json\/wp\/v2\/media?parent=369"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}