{"id":38,"date":"2022-11-01T12:46:17","date_gmt":"2022-11-01T12:46:17","guid":{"rendered":"https:\/\/operonstrategist.com\/costarica\/?page_id=38"},"modified":"2025-09-17T08:43:17","modified_gmt":"2025-09-17T08:43:17","slug":"iso-15378-certification-primary-packging-regulatory-consulting","status":"publish","type":"page","link":"https:\/\/operonstrategist.com\/en-br\/services\/turnkey-project-consultants\/iso-15378-certification-primary-packging-regulatory-consulting\/","title":{"rendered":"ISO 15378 CERTIFICATION | PRIMARY PACKAGING REGULATORY CONSULTING"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"38\" class=\"elementor elementor-38\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-63dcd5ff banner-sec elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"63dcd5ff\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-245e2be\" data-id=\"245e2be\" data-element_type=\"column\" data-e-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-28352313 banner-sec-heading elementor-widget elementor-widget-heading\" data-id=\"28352313\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">ISO 15378 Certification for Primary Packaging <\/h1>\t\t\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<section class=\"elementor-section elementor-top-section elementor-element elementor-element-aa56092 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"aa56092\" data-element_type=\"section\" data-e-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=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-2f9d4557\" data-id=\"2f9d4557\" data-element_type=\"column\" data-e-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-193e85f elementor-widget elementor-widget-heading\" data-id=\"193e85f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">What is ISO 15378 Certification? <\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-785c2b85 elementor-widget elementor-widget-text-editor\" data-id=\"785c2b85\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>ISO 15378:2017 specifies the requirements for a quality management system for organizations that manufacture primary packaging materials for medicinal products. It integrates Good Manufacturing Practices (GMP) with ISO 9001:2015 principles to ensure quality, safety, and traceability.\u00a0<\/p><p>This certification is applicable to all manufacturers of packaging materials that come into direct contact with medicinal products, such as glass, plastics, rubber, and aluminum. It ensures compliance with both international standards and Brazilian regulatory requirements, boosting market acceptance and customer trust.\u00a0<\/p><p><span class=\"TextRun SCXW118514072 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW118514072 BCX8\">Operon Strategist<\/span><\/span><span class=\"TextRun SCXW118514072 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW118514072 BCX8\"> provides end-to-end consulting services for <\/span><\/span><span class=\"TextRun SCXW118514072 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW118514072 BCX8\">ISO 15378 Certification in Brazil<\/span><\/span><span class=\"TextRun SCXW118514072 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW118514072 BCX8\">, ensuring compliance with global quality standards and regulatory requirements for primary packaging materials in the pharmaceutical and medical device industries. With our expertise, we help manufacturers implement GMP-based systems and achieve certification successfully.<\/span><\/span><span class=\"EOP SCXW118514072 BCX8\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:0,&quot;335551620&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\t\t\t\t\t\t\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=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-5e60eaec\" data-id=\"5e60eaec\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;none&quot;}\">\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-6d349b75 elementor-widget elementor-widget-heading\" data-id=\"6d349b75\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Let's Grow Your Business Together<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-124e987d elementor-widget elementor-widget-text-editor\" data-id=\"124e987d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\tLet&#8217;s have word about your next project\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3d0d6a1b elementor-widget elementor-widget-wpforms\" data-id=\"3d0d6a1b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"wpforms.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"wpforms-container wpforms-container-full wpforms-render-modern\" id=\"wpforms-2624\"><form id=\"wpforms-form-2624\" class=\"wpforms-validate wpforms-form wpforms-ajax-form\" data-formid=\"2624\" method=\"post\" enctype=\"multipart\/form-data\" action=\"\/en-br\/wp-json\/wp\/v2\/pages\/38\" data-token=\"ee7ec6fd45571d110b54016d080a59c1\" data-token-time=\"1775556733\"><noscript class=\"wpforms-error-noscript\">Please enable JavaScript in your browser to complete this form.<\/noscript><div id=\"wpforms-error-noscript\" style=\"display: none;\">Please enable JavaScript in your browser to complete this form.<\/div><div class=\"wpforms-field-container\"><div id=\"wpforms-2624-field_0-container\" class=\"wpforms-field wpforms-field-name\" data-field-id=\"0\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-2624-field_0\" aria-hidden=\"false\">Name <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"text\" id=\"wpforms-2624-field_0\" class=\"wpforms-field-large 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type=\"hidden\" name=\"wpforms[id]\" value=\"2624\"><input type=\"hidden\" name=\"page_title\" value=\"\"><input type=\"hidden\" name=\"page_url\" value=\"https:\/\/operonstrategist.com\/en-br\/wp-json\/wp\/v2\/pages\/38\"><input type=\"hidden\" name=\"url_referer\" value=\"\"><button type=\"submit\" name=\"wpforms[submit]\" id=\"wpforms-submit-2624\" class=\"wpforms-submit\" data-alt-text=\"Sending...\" data-submit-text=\"Submit\" aria-live=\"assertive\" value=\"wpforms-submit\">Submit<\/button><img decoding=\"async\" src=\"https:\/\/operonstrategist.com\/en-br\/wp-content\/plugins\/wpforms-lite\/assets\/images\/submit-spin.svg\" class=\"wpforms-submit-spinner\" style=\"display: none;\" width=\"26\" height=\"26\" alt=\"Loading\"><\/div><\/form><\/div>  <!-- .wpforms-container -->\t\t\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<section class=\"elementor-section elementor-top-section elementor-element elementor-element-358a23ca elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"358a23ca\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-3bb992b2\" data-id=\"3bb992b2\" data-element_type=\"column\" data-e-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-4f5ce714 elementor-widget elementor-widget-heading\" data-id=\"4f5ce714\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Key Requirements of ISO 15378 Certification <\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3711998 elementor-widget elementor-widget-text-editor\" data-id=\"3711998\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span data-contrast=\"auto\">To achieve certification, organizations must comply with:<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:0,&quot;335551620&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p><ul><li><b><span data-contrast=\"auto\">Good Manufacturing Practices (GMP):<\/span><\/b><span data-contrast=\"auto\"> Maintain consistent quality and prevent contamination.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:0,&quot;335551620&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/li><li><b><span data-contrast=\"auto\">Risk Management:<\/span><\/b><span data-contrast=\"auto\"> Identify and mitigate risks in packaging and production processes.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:0,&quot;335551620&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/li><li><b><span data-contrast=\"auto\">Documentation Control:<\/span><\/b><span data-contrast=\"auto\"> Ensure accurate, traceable records for compliance.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:0,&quot;335551620&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/li><li><b><span data-contrast=\"auto\">Supplier Management:<\/span><\/b><span data-contrast=\"auto\"> Work only with suppliers meeting ISO 15378 standards.<\/span><\/li><\/ul>\t\t\t\t\t\t\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=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-bc368a9\" data-id=\"bc368a9\" data-element_type=\"column\" data-e-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-272cf3c7 elementor-widget elementor-widget-image\" data-id=\"272cf3c7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"2500\" height=\"1246\" src=\"https:\/\/operonstrategist.com\/en-br\/wp-content\/uploads\/2025\/08\/ISO-15378-Certification-for-Primary-Packaging-01.jpg\" class=\"attachment-full size-full wp-image-3704\" alt=\"ISO 15378 certification for primary packaging\" srcset=\"https:\/\/operonstrategist.com\/en-br\/wp-content\/uploads\/2025\/08\/ISO-15378-Certification-for-Primary-Packaging-01.jpg 2500w, https:\/\/operonstrategist.com\/en-br\/wp-content\/uploads\/2025\/08\/ISO-15378-Certification-for-Primary-Packaging-01-300x150.jpg 300w, https:\/\/operonstrategist.com\/en-br\/wp-content\/uploads\/2025\/08\/ISO-15378-Certification-for-Primary-Packaging-01-1024x510.jpg 1024w, https:\/\/operonstrategist.com\/en-br\/wp-content\/uploads\/2025\/08\/ISO-15378-Certification-for-Primary-Packaging-01-768x383.jpg 768w, https:\/\/operonstrategist.com\/en-br\/wp-content\/uploads\/2025\/08\/ISO-15378-Certification-for-Primary-Packaging-01-1536x766.jpg 1536w, https:\/\/operonstrategist.com\/en-br\/wp-content\/uploads\/2025\/08\/ISO-15378-Certification-for-Primary-Packaging-01-2048x1021.jpg 2048w\" sizes=\"(max-width: 2500px) 100vw, 2500px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\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<section class=\"elementor-section elementor-top-section elementor-element elementor-element-058ad1b elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"058ad1b\" data-element_type=\"section\" data-e-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=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-67be720\" data-id=\"67be720\" data-element_type=\"column\" data-e-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-2330eed elementor-widget elementor-widget-heading\" data-id=\"2330eed\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Benefits of ISO 15378 Certification in Brazil <\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4808e4f elementor-widget elementor-widget-text-editor\" data-id=\"4808e4f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li>Assures the quality and safety of primary packaging materials.\u00a0<\/li><li>Reduces risks of contamination, errors, and mix-ups.\u00a0<\/li><li>Increases market access and competitiveness in Brazil and globally.\u00a0<\/li><li>Improves customer satisfaction and regulatory compliance.\u00a0<\/li><li>Supports cost reduction through process efficiency and waste minimization.<\/li><\/ul>\t\t\t\t\t\t\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<section class=\"elementor-section elementor-top-section elementor-element elementor-element-f591201 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"f591201\" data-element_type=\"section\" data-e-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=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-919a5a5\" data-id=\"919a5a5\" data-element_type=\"column\" data-e-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-30d7acf elementor-widget elementor-widget-heading\" data-id=\"30d7acf\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">ISO Training Services for Certification Success<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-89377aa elementor-widget elementor-widget-text-editor\" data-id=\"89377aa\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>We offer a range of ISO training services to support companies in their certification journey. Our training solutions include:<\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><p>ISO 15378 Training: Comprehensive training to help your team understand the requirements and implementation of ISO 15378.<\/p><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><p><a href=\"https:\/\/operonstrategist.com\/en-br\/services\/turnkey-project-consultants\/iso-13485-qms-medical-device\/\">ISO 13485<\/a> Certification Training: A detailed course to guide companies through the <a href=\"https:\/\/operonstrategist.com\/en-br\/services\/turnkey-project-consultants\/quality-management-system\/\">quality management system<\/a> requirements for medical devices.<\/p><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><p>ISO 13485 Internal Auditor Course: Equip your team with the skills to perform internal audits and ensure compliance with ISO 13485.<\/p><\/li><\/ul><p>Training is crucial to maintain standards and facilitate a smooth certification process.<\/p>\t\t\t\t\t\t\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<section class=\"elementor-section elementor-top-section elementor-element elementor-element-7eee8c85 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7eee8c85\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-2299988a\" data-id=\"2299988a\" data-element_type=\"column\" data-e-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-243d1978 elementor-widget elementor-widget-heading\" data-id=\"243d1978\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Application of ISO 15378<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cb385a1 elementor-widget elementor-widget-text-editor\" data-id=\"cb385a1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ol><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">ISO 15378:2017 is an application standard for the structure, manufacture and supply of primary packaging material for the medicinal product.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">It is additionally appropriate for certification purposes of primary packaging material for medicinal products in pharmaceuticals and medical device industries. This primary packaging standard discovers Good manufacturing practice (GMP) standards and Quality Management System relevant to primary packaging materials for medicinal products.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">ISO 15378 can be utilized for quality improvement, training, auditing and certification.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The ISO 15378 standard is assessed at every 5 years.<\/span><\/li><\/ol>\t\t\t\t\t\t\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<section class=\"elementor-section elementor-top-section elementor-element elementor-element-373a0473 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"373a0473\" data-element_type=\"section\" data-e-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=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-385e78bc\" data-id=\"385e78bc\" data-element_type=\"column\" data-e-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-89b8b75 elementor-widget elementor-widget-heading\" data-id=\"89b8b75\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Role of Operon Strategist in ISO 15378 Certification <\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-539e35c8 elementor-widget elementor-widget-text-editor\" data-id=\"539e35c8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span data-contrast=\"auto\">As an expert <\/span><b><span data-contrast=\"auto\">medical device and pharmaceutical packaging consultant<\/span><\/b><span data-contrast=\"auto\">, Operon Strategist helps manufacturers in Brazil with:<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:0,&quot;335551620&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p><ul><li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"50\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">GAP Analysis<\/span><\/b><span data-contrast=\"auto\"> of existing systems.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:0,&quot;335551620&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/li><\/ul><ul><li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"50\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">QMS Implementation<\/span><\/b><span data-contrast=\"auto\"> aligned with ISO 15378:2017 and GMP.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:0,&quot;335551620&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/li><\/ul><ul><li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"50\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"3\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Documentation Support<\/span><\/b><span data-contrast=\"auto\"> (procedures, manuals, records).<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:0,&quot;335551620&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/li><\/ul><ul><li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"50\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"4\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Training Programs<\/span><\/b><span data-contrast=\"auto\"> for staff and internal auditors.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:0,&quot;335551620&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/li><\/ul><ul><li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"50\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"5\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Audit Preparedness<\/span><\/b><span data-contrast=\"auto\"> to ensure smooth certification.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:0,&quot;335551620&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/li><\/ul><p><span data-contrast=\"auto\">We guide you through every step of certification, ensuring timely deliverables and error-free compliance.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:0,&quot;335551620&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p><p><span style=\"font-family: georgia, palatino; font-size: 12pt;\">We also provide medical device consultation for\u00a0<a href=\"https:\/\/operonstrategist.com\/\">India,<\/a>\u00a0<a href=\"https:\/\/operonstrategist.com\/en-sa\/\" target=\"_blank\" rel=\"noopener\">Saudi Arabia<\/a>, <a href=\"https:\/\/operonstrategist.com\/en-dz\/\">Algeria<\/a>,<a href=\"https:\/\/us.operonstrategist.com\/\" rel=\"nofollow noopener\">\u00a0the USA<\/a>,\u00a0<a href=\"https:\/\/operonstrategist.com\/en-gb\/\">the UK<\/a>,\u00a0<a href=\"https:\/\/operonstrategist.com\/en-za\/\">South Africa<\/a>,\u00a0<a href=\"https:\/\/operonstrategist.com\/en-om\/\">Oman<\/a>,\u00a0<a href=\"https:\/\/operonstrategist.com\/en-ir\/\">Iran<\/a>\u00a0&amp;\u00a0<a href=\"https:\/\/operonstrategist.com\/en-gb\/\">Egypt<\/a>. Feel free to <a href=\"https:\/\/operonstrategist.com\/en-cr\/contact-us\/\">contact us.<\/a><\/span><\/p>\t\t\t\t\t\t\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<section class=\"elementor-section elementor-top-section elementor-element elementor-element-df4eadb elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"df4eadb\" data-element_type=\"section\" data-e-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=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-ea7907a\" data-id=\"ea7907a\" data-element_type=\"column\" data-e-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-007f5bf elementor-widget elementor-widget-heading\" data-id=\"007f5bf\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">FAQs<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b43e262 elementor-widget elementor-widget-shortcode\" data-id=\"b43e262\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"shortcode.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-shortcode\"><div id=\"rank-math-rich-snippet-wrapper\"><div id=\"rank-math-faq\" class=\"rank-math-block\">\n<div class=\"rank-math-list \">\n<div id=\"faq-1\" class=\"rank-math-list-item\">\n<h3 class=\"rank-math-question \">What is ISO 15378 certification?<\/h3>\n<div class=\"rank-math-answer \">\n\n<p>ISO 15378 is an international standard that specifies Good Manufacturing Practices (GMP) for primary packaging materials used in medicinal products. It ensures quality, safety, and regulatory compliance in pharmaceutical packaging.<\/p>\n\n<\/div>\n<\/div>\n<div id=\"faq-2\" class=\"rank-math-list-item\">\n<h3 class=\"rank-math-question \">Who needs ISO 15378 certification?<\/h3>\n<div class=\"rank-math-answer \">\n\n<p>ISO 15378 certification is essential for manufacturers of primary packaging materials such as glass, plastic, rubber, and aluminum used in the pharmaceutical and medical device industries.<\/p>\n\n<\/div>\n<\/div>\n<div id=\"faq-3\" class=\"rank-math-list-item\">\n<h3 class=\"rank-math-question \">How does ISO 15378 help with GMP compliance?<\/h3>\n<div class=\"rank-math-answer \">\n\n<p>ISO 15378 incorporates GMP principles, ensuring that primary packaging materials meet pharmaceutical industry quality and safety requirements while complying with international regulations.<\/p>\n\n<\/div>\n<\/div>\n<\/div>\n<\/div><\/div><\/div>\n\t\t\t\t\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>ISO 15378 Certification for Primary Packaging What is ISO 15378 Certification? ISO 15378:2017 specifies the requirements for a quality management system for organizations that manufacture primary packaging materials for medicinal products. It integrates Good Manufacturing Practices (GMP) with ISO 9001:2015 principles to ensure quality, safety, and traceability.\u00a0 This certification is applicable to all manufacturers of [&hellip;]<\/p>\n","protected":false},"author":9,"featured_media":3704,"parent":18,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"site-sidebar-layout":"no-sidebar","site-content-layout":"page-builder","ast-site-content-layout":"full-width-container","site-content-style":"unboxed","site-sidebar-style":"unboxed","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"disabled","ast-breadcrumbs-content":"","ast-featured-img":"disabled","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"class_list":["post-38","page","type-page","status-publish","has-post-thumbnail","hentry"],"_links":{"self":[{"href":"https:\/\/operonstrategist.com\/en-br\/wp-json\/wp\/v2\/pages\/38","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/operonstrategist.com\/en-br\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/operonstrategist.com\/en-br\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/en-br\/wp-json\/wp\/v2\/users\/9"}],"replies":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/en-br\/wp-json\/wp\/v2\/comments?post=38"}],"version-history":[{"count":5,"href":"https:\/\/operonstrategist.com\/en-br\/wp-json\/wp\/v2\/pages\/38\/revisions"}],"predecessor-version":[{"id":3885,"href":"https:\/\/operonstrategist.com\/en-br\/wp-json\/wp\/v2\/pages\/38\/revisions\/3885"}],"up":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/en-br\/wp-json\/wp\/v2\/pages\/18"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/en-br\/wp-json\/wp\/v2\/media\/3704"}],"wp:attachment":[{"href":"https:\/\/operonstrategist.com\/en-br\/wp-json\/wp\/v2\/media?parent=38"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}