[et_pb_section fb_built=”1″ _builder_version=”4.16″ custom_margin=”-3px|||||” custom_padding=”30px|||||” global_colors_info=”{}”][et_pb_row _builder_version=”4.16″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” min_height=”954.1px” custom_padding=”3px|||||” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_image src=”https:\/\/cadtech.es\/wp-content\/uploads\/2026\/05\/ISO-15378-como-garantizar-calidad-3DEXPERIENCE.jpg” title_text=”ISO 15378 c\u00f3mo garantizar calidad 3DEXPERIENCE” _builder_version=”4.27.6″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_image][et_pb_text _builder_version=”4.27.6″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” min_height=”117.1px” custom_padding=”||3px|||” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n
Pharmaceutical packaging is already a critical compliance element<\/strong><\/span><\/p>\n Today, the pharmaceutical industry requires much stricter control over materials, traceability, quality, and GMP processes. Primary packaging is no longer just a packaging element but has become a key component of safety and regulatory compliance.<\/p>\n In this context, ISO 15378 has become the leading international standard for pharmaceutical packaging manufacturers, as it combines ISO 9001 quality requirements with Good Manufacturing Practices (GMP).<\/p>\n Its objective is to ensure that manufacturers have robust systems for document control, traceability, and risk management capable of meeting current regulatory requirements.<\/p>\n [\/et_pb_text][et_pb_text _builder_version=”4.27.6″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” min_height=”209.1px” custom_padding=”||3px|||” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n ISO 15378 defines the quality requirements applicable to manufacturers of primary pharmaceutical packaging and packaging components used in medicinal products.<\/p>\n The standard focuses on essential aspects such as:<\/p>\n In practice, it requires companies to implement much more controlled and auditable processes throughout the entire packaging manufacturing chain.<\/p>\n [\/et_pb_text][et_pb_text _builder_version=”4.27.6″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” min_height=”143.1px” custom_padding=”||3px|||” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n Manufacturers in the sector must face increasing regulatory and operational pressure. Among the main challenges are continuous audits, process validation, supplier control, and document management associated with GMP.<\/p>\n Added to this is a common problem: many companies still work with disconnected systems across quality, production, documentation, and supply chain, making it difficult to maintain complete and reliable traceability.<\/p>\n Dassault Syst\u00e8mes specifically highlights the importance of having secure, accessible, and consistent data to ensure regulatory integrity and facilitate compliance.<\/p>\n [\/et_pb_text][et_pb_text _builder_version=”4.27.6″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” min_height=”209.1px” custom_padding=”||3px|||” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n Dassault Syst\u00e8mes<\/a> identifies the 3DEXPERIENCE platform<\/a> as a solution designed to support Life Sciences regulations such as ISO 15378 thanks to its integrated approach to quality, traceability, and document management.<\/p>\n Centralized GMP document management<\/strong><\/p>\n The platform makes it possible to centralize all critical documentation related to quality and compliance. This includes SOPs, procedures, approvals, version control, and audit trails, while also ensuring secure access and full traceability of implemented changes.<\/p>\n Integrated CAPA and deviation management<\/strong><\/p>\n One of the most relevant aspects of ISO 15378 is the ability to manage incidents in a structured way.<\/p>\n 3DEXPERIENCE connects non-conformities, CAPAs, audits, deviations, and change control processes within the same digital environment. This way, all information remains linked to the corresponding product and process, facilitating audits and investigations.<\/p>\n Risk management and Quality Risk Management<\/strong><\/p>\n The standard requires the implementation of a continuous risk management approach. The platform makes it possible to identify risks, assess impact, automate corrective actions, and connect quality controls with critical processes.<\/p>\n Dassault highlights the risk-based thinking approach as one of the pillars of modern Quality Management and the digitalization of pharmaceutical compliance.<\/p>\n Complete traceability of pharmaceutical packaging<\/strong><\/p>\n Another key aspect is the full traceability of materials, production, and quality.<\/p>\n 3DEXPERIENCE connects raw materials, suppliers, production processes, supply chain, and audits within the same platform, facilitating recalls, regulatory investigations, and GMP audits in a much more agile way.<\/p>\n [\/et_pb_text][et_pb_text _builder_version=”4.27.6″ _module_preset=”default” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n The digitalization of the sector is driving a shift from reactive models toward predictive quality strategies.<\/p>\n 3DEXPERIENCE incorporates advanced analytics, artificial intelligence, and smart reporting capabilities to detect issues before they impact production or compliance.<\/p>\n The goal is to evolve toward a digital Total Quality Management model, where quality is managed proactively and driven by data.<\/p>\n [\/et_pb_text][et_pb_text _builder_version=”4.27.6″ _module_preset=”default” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n Implementing ISO 15378 supported by an integrated platform makes it possible to:<\/p>\n [\/et_pb_text][et_pb_text _builder_version=”4.27.6″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n [\/et_pb_text][et_pb_accordion _builder_version=”4.27.6″ _module_preset=”default” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″][et_pb_accordion_item title=”What does ISO 15378 regulate?” open=”on” _builder_version=”4.27.6″ _module_preset=”default” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n It regulates quality systems and Good Manufacturing Practices applied to primary pharmaceutical packaging.<\/p>\n [\/et_pb_accordion_item][et_pb_accordion_item title=”Which companies must comply with ISO 15378?” _builder_version=”4.27.6″ _module_preset=”default” hover_enabled=”0″ global_colors_info=”{}” open=”off” sticky_enabled=”0″]<\/p>\n Mainly manufacturers of packaging, components, and materials used in pharmaceutical products.<\/p>\n [\/et_pb_accordion_item][et_pb_accordion_item title=”What is the relationship between ISO 15378 and GMP?” _builder_version=”4.27.6″ _module_preset=”default” hover_enabled=”0″ global_colors_info=”{}” open=”off” sticky_enabled=”0″]<\/p>\n The standard integrates ISO 9001 requirements together with GMP principles specific to pharmaceutical packaging.<\/p>\n [\/et_pb_accordion_item][et_pb_accordion_item title=”How does a PLM help pharmaceutical packaging?” _builder_version=”4.27.6″ _module_preset=”default” hover_enabled=”0″ global_colors_info=”{}” open=”off” sticky_enabled=”0″]<\/p>\n A PLM makes it possible to connect quality, documentation, traceability, and regulatory processes within a single digital platform.<\/p>\n [\/et_pb_accordion_item][\/et_pb_accordion][et_pb_text _builder_version=”4.27.6″ _module_preset=”default” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n Complying with ISO 15378 is not only about managing GMP documentation. The real challenge lies in connecting quality, traceability, risks, manufacturing, and compliance within a digital environment prepared to respond to audits and global regulatory requirements.<\/p>\n At CADTECH, we help companies in the Life Sciences and pharmaceutical packaging sectors implement 3DEXPERIENCE-based solutions to digitalize quality processes and ensure integrated compliance management.<\/p>\n Our team supports organizations in implementing Quality Management, traceability, and document management strategies adapted to standards such as ISO 15378, FDA 21 CFR Part 11, or the European MDR, facilitating the transition toward more connected, auditable, and scalable quality models.<\/p>\n [\/et_pb_text][et_pb_divider _builder_version=”4.27.6″ _module_preset=”default” custom_margin=”-21px|||||” global_colors_info=”{}”][\/et_pb_divider][et_pb_text _builder_version=”4.27.6″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n CADTECH Communications Department<\/strong><\/span><\/p>\n comunicacion@cadtech.es \u2013 800 007 177<\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":" Pharmaceutical packaging is already a critical compliance element Today, the pharmaceutical industry requires much stricter control over materials, traceability, quality, and GMP processes. Primary packaging is no longer just a packaging element but has become a key component of safety and regulatory compliance. In this context, ISO 15378 has become the leading international standard for pharmaceutical packaging manufacturers, as it combines ISO 9001 quality requirements with Good Manufacturing Practices (GMP). Its objective is to ensure that manufacturers have robust systems for document control, traceability, and risk management capable of meeting current regulatory requirements.What is ISO 15378? ISO 15378 defines the quality requirements applicable to manufacturers of primary pharmaceutical packaging and packaging components used in medicinal products. The standard focuses on essential aspects such as: Product safety, Traceability, Document control, Risk management, Continuous improvement, GMP compliance. In practice, it requires companies to implement much more controlled and auditable processes throughout the entire packaging manufacturing chain.The current challenges of pharmaceutical packaging Manufacturers in the sector must face increasing regulatory and operational pressure. Among the main challenges are continuous audits, process validation, supplier control, and document management associated with GMP. Added to this is a common problem: many companies still work with disconnected […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"categories":[227],"tags":[],"class_list":["post-272288","post","type-post","status-publish","format-standard","hentry","category-life-sciences"],"acf":[],"yoast_head":"\nWhat is ISO 15378?<\/h2>\n
\n
The current challenges of pharmaceutical packaging<\/h2>\n
How 3DEXPERIENCE helps comply with ISO 15378<\/h2>\n
From traditional Quality Management to predictive quality<\/h2>\n
Benefits of ISO 15378 with 3DEXPERIENCE<\/h2>\n
\n
FAQ \u2014 ISO 15378<\/h2>\n
How CADTECH can help you<\/h2>\n