In the pharmaceutical sector, primary packaging is not simply an element used to protect or present a product. It forms part of the quality system that ensures medicinal product safety. For this reason, materials that come into direct contact with the pharmaceutical product must be manufactured under controlled conditions and within a quality framework aligned with Good Manufacturing Practices (GMP). However, not all flexible packaging manufacturers operate under the same level of requirements.
In Spain, manufacturing under ISO 15378 certification and within ISO 8 cleanroom conditions involves integrating environmental control, document traceability, risk management and process validation into the industrial structure itself.
At Rotor Print, we operate within this framework because we understand that packaging is not an ancillary component of the medicinal product. It is a critical element of the product safety system.
But what does operating under these conditions really mean at an industrial level?
ISO 15378 applied to pharmaceutical packaging
The ISO 15378 standard is specifically designed for manufacturers of primary packaging for medicinal products. Its purpose is to integrate the quality principles of ISO 9001 with the GMP requirements applicable to the pharmaceutical sector.
This means that the company must demonstrate that all processes are controlled, documented and designed to ensure the safety of the final product. In addition, any deviation, change or incident must be managed through traceable and auditable procedures.
Operating under ISO 15378 requires the implementation of systems capable of ensuring batch-to-batch consistency, risk control and stability throughout production processes.
ISO 15378 and GMP requirements for primary pharmaceutical packaging
The relationship between ISO 15378 and Good Manufacturing Practices (GMP) is direct. The standard incorporates GMP principles specifically adapted to pharmaceutical packaging and primary packaging for medicinal products.
In practice, this means that the manufacturer must operate under a system capable of demonstrating, through verifiable evidence, that the process is controlled at every stage.
Operating under ISO 15378 means that:
- Any change in raw materials, formulations or process parameters must be assessed before implementation
- Every production batch must be traceable from origin to dispatch
- Deviations must be investigated through documented procedures
- Critical processes must remain under continuous control
In addition, all production-related information must be recorded and available for regulatory audits or technical investigations.
For this reason, ISO 15378 requires a significantly higher level of industrial, operational and document control than more general quality management systems.
Differences between ISO 9001 and ISO 15378 in pharmaceutical packaging
Although both standards share quality management principles, ISO 15378 is specifically focused on the risks associated with primary pharmaceutical packaging.
ISO 9001 establishes general requirements applicable across multiple industrial sectors. ISO 15378, however, introduces additional requirements related to:
- Environmental control
- GMP risk management
- Advanced traceability
- Process validation
For this reason, having ISO 9001 certification alone does not imply compliance with the specific requirements established by the pharmaceutical industry for primary packaging for medicinal products.
Flexible packaging production in ISO 8 cleanroom conditions
In addition to the documentation system, the production environment directly influences the safety of pharmaceutical packaging. ISO 8 cleanrooms are controlled environments designed to limit airborne particle levels and maintain stable environmental conditions throughout the manufacturing process.
At Rotor Print, production for the pharmaceutical sector is carried out in cleanrooms integrated within the quality system certified under ISO 15378, meaning that environmental control forms part of the industrial management model itself.
Working in ISO 8 cleanrooms with controlled environmental conditions in pharmaceutical packaging
Operating in ISO 8 cleanrooms with controlled environmental conditions involves the continuous control of variables such as:
- Particle levels maintained within established limits
- High-efficiency absolute HEPA filtration systems (H13 and H14)
- Documented environmental monitoring
- Strict access protocols and technical gowning procedures
- Auditable environmental records
In addition, all environmental records must be documented and available for audits. This level of control helps minimise contamination risk and maintain stability throughout the production process.
Environmental and particle control in primary pharmaceutical packaging
Environmental control also enables operation under stable and repeatable conditions, which are essential to ensure batch-to-batch consistency and reduce risks in primary packaging for medicinal products.
Operational implications for flexible film manufacturers
Manufacturing pharmaceutical packaging under ISO 15378 requires a significantly more complex industrial structure than conventional production.
Complete batch-to-batch traceability
Each batch must be traceable from the raw materials used through to the final product dispatch.
This includes intermediate controls, production parameters, quality verifications and all documentation associated with the process.
Thanks to this complete traceability, it is possible to respond quickly to regulatory audits or technical investigations.
Change management
When packaging forms part of a laboratory’s GMP system, any modification must be assessed in advance.
This includes changes related to:
- Raw materials
- Formulations
- Suppliers
- Process parameters
Each change must undergo a documented impact assessment and risk analysis before implementation.
Control of critical processes
Processes such as lamination, printing and slitting must be documented and kept under continuous control. This helps ensure process stability, material consistency and compliance with customer requirements, while preventing non-conformities.
Continuous audit readiness
Companies certified under ISO 15378 must be prepared for regular audits carried out both by certification bodies and pharmaceutical laboratories.
This requires keeping internal procedures, staff technical training and all quality and production documentation continuously updated.
In other words, audit readiness forms part of the organisation’s day-to-day operations.
Process validation and regulatory compliance
Validation makes it possible to demonstrate that production processes operate under controlled conditions.
In addition, it supports regulatory compliance and provides additional assurance to pharmaceutical laboratories that integrate packaging within their GMP systems.
How common is this combination in Europe?
Across the European flexible packaging industry, different levels of quality control and production environments coexist depending on the application.
ISO 15378 certification is present among manufacturers supplying primary packaging for pharmaceutical use, particularly in more mature markets. Similarly, the use of cleanroom environments with controlled conditions is also implemented in specific stages of the production process.
However, the integration of both elements within the same industrial model, combining ISO 15378 certification with production in cleanrooms operating under ISO 8 environmental conditions throughout the entire manufacturing process, is not common.
This level of integration requires advanced infrastructure, strict process control and a quality system capable of aligning environmental conditions, traceability and operational discipline within a single framework.
Why it matters for pharmaceutical companies
When primary packaging forms part of the customer’s GMP system, the supplier is no longer simply a manufacturer of printed materials. It becomes a critical link within the medicinal product safety system.
Risk reduction and continuity of supply
The combination of cleanrooms with ISO 8 environmental control, full traceability and ISO 15378 certification helps reduce regulatory risk, facilitate audits and improve supply stability.
In addition, working with specialised suppliers helps ensure consistency across materials, processes and technical specifications. All of this contributes to strengthening product safety and the reliability of the industrial supply chain.
Rotor Print’s industrial approach
At Rotor Print, we understand that pharmaceutical packaging requires a real and verifiable level of control. For this reason, we operate under ISO 15378 certification and within ISO 8 cleanrooms with controlled environmental conditions, fully integrated into our industrial quality system.
Pharmaceutical flexible packaging with full process control
Our objective is not only to manufacture flexible packaging with high graphic quality. We also aim to ensure documented traceability, batch-to-batch stability and continuous readiness for regulatory audits.
In addition, we are part of SP Group, an international industrial group specialised in advanced flexible and thermoformable packaging solutions.
This structure strengthens our technical capabilities and allows us to provide integrated solutions for the pharmaceutical industry within a highly controlled production environment.
If you are looking for a pharmaceutical packaging manufacturer operating under ISO 15378 and within ISO 8 cleanroom environments, Rotor Print can support your requirements. Contact our team to discover how to achieve greater traceability, control and safety in your primary packaging for medicinal products.
