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 systems across quality, production, documentation, and supply chain, making it difficult to maintain complete and reliable traceability.
Dassault Systèmes specifically highlights the importance of having secure, accessible, and consistent data to ensure regulatory integrity and facilitate compliance.
How 3DEXPERIENCE helps comply with ISO 15378
Dassault Systèmes identifies the 3DEXPERIENCE platform as a solution designed to support Life Sciences regulations such as ISO 15378 thanks to its integrated approach to quality, traceability, and document management.
Centralized GMP document management
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.
Integrated CAPA and deviation management
One of the most relevant aspects of ISO 15378 is the ability to manage incidents in a structured way.
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.
Risk management and Quality Risk Management
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.
Dassault highlights the risk-based thinking approach as one of the pillars of modern Quality Management and the digitalization of pharmaceutical compliance.
Complete traceability of pharmaceutical packaging
Another key aspect is the full traceability of materials, production, and quality.
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.
From traditional Quality Management to predictive quality
The digitalization of the sector is driving a shift from reactive models toward predictive quality strategies.
3DEXPERIENCE incorporates advanced analytics, artificial intelligence, and smart reporting capabilities to detect issues before they impact production or compliance.
The goal is to evolve toward a digital Total Quality Management model, where quality is managed proactively and driven by data.
Benefits of ISO 15378 with 3DEXPERIENCE
Implementing ISO 15378 supported by an integrated platform makes it possible to:
- Improve GMP control,
- Reduce regulatory risks,
- Increase traceability,
- Streamline audits,
- Optimize document management,
- Strengthen the trust of clients in the pharma sector.
FAQ — ISO 15378
What does ISO 15378 regulate?
It regulates quality systems and Good Manufacturing Practices applied to primary pharmaceutical packaging.
Which companies must comply with ISO 15378?
Mainly manufacturers of packaging, components, and materials used in pharmaceutical products.
What is the relationship between ISO 15378 and GMP?
The standard integrates ISO 9001 requirements together with GMP principles specific to pharmaceutical packaging.
How does a PLM help pharmaceutical packaging?
A PLM makes it possible to connect quality, documentation, traceability, and regulatory processes within a single digital platform.
How CADTECH can help you
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.
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.
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.
CADTECH Communications Department
comunicacion@cadtech.es – 800 007 177