ISO 15378 - Primary Packaging Materials For Medicinal Products

 

What is ISO 15378?

ISO 15378 is an international standard that outlines the quality management system requirements for manufacturers of primary packaging materials used for medicinal products, such as drugs and medical devices.

This standard also ensures that packaging consistently meets customer and regulatory requirements, by incorporating Good Manufacturing Practice (GMP) principles. In turn, it sets the benchmark for producing reliable and safe packaging for pharmaceuticals and medical devices that come into direct contact with the product itself.

Once certified, organisations can proudly promote themselves as certificate holders in any of their promotional materials and can include the URS certification logo free of charge.

 

Who requires an ISO 15378 certification?

ISO 15378 is an essential standard for the manufacturers of any pharmaceutical packaging that comes into direct contact with medicinal products or medical devices.

 

How can ISO 15378 benefit your business?

Becoming certified for ISO 15378 can bring a wide range of benefits to your organisation, including:

 

• Improved product quality


• Enhanced customer trust


• Optimised processes


• Reduced risk

How can you prepare for an ISO 15378 Certification?

Although the thought of starting the certification process may seem daunting, there are a variety of steps you can take to make the process to becoming certified far more streamlined:

 

• Familiarise yourself with the ISO 15378 standard


• Conduct a gap analysis


• Develop a Quality Management System


• Provide training to staff members to ensure employee competency meets the standard requirements


• Carry out internal audits to highlight opportunities for improvement

What are the key requirements ISO 15378?

When working towards becoming certified for ISO 15378, there are various areas that will be a focus during the audit. These areas include:

 

• Material control


• Batch traceability


• Risk management


• Quality documentation


• Environmental control

What clauses make up the structure of ISO 15378?

 

 

Clause 1-3 – Introductory Clauses:

The first three clauses in ISO 15378 serve as an introduction to the standard and outline the scope, normative references and the terms and definitions. These sections also include a brief exploration of the standard’s history, approach and compatibility with other standards.

The seven remaining clauses cover the guidelines related to complaints handling and address customer satisfaction, the needs and expectations of complainants, and the methods of reviewing and maintaining the implemented complaints process.

 

Clause 4 – Context of the organisation

Clause 4 focuses on the context of the organization. It emphasizes the need for a company to understand internal and external issues that can affect its ability to achieve its intended results. To do this, it explores understanding the organisation and the needs and expectations of interested parties.



Climate Change Amendments:

The amendments have not changed the requirements of clause 4.1 and 4.2, rather they have added an assurance that climate change is considered for the management system. Due to the necessity of climate awareness, it should be considered by organisations and is therefore included as part of the standard.

Rather than a transition being required, organisations should instead consider and apply the guidance provided in the amendment. Should a company minute their considerations during their Management Review regarding CCC as well as evidence of their considerations and any actions, a discrepancy shall NOT be raised. However, should no minute exist for any considerations, then a discrepancy will be raised.

Where a minute and evidence does exist but is clearly of little relevance to CCC an Opportunity for Improvement (OFI) will be raised.

 

Clause 5 – Leadership

Clause 5 requires top management to take ownership of the QMS, demonstrate their commitment, and ensure that the organization is focused on meeting customer needs and achieving its quality objectives.

 

Clause 6 – Planning

Clause 6 requires organizations to proactively plan their QMS, identify and address potential risks and opportunities, set quality objectives, and manage changes effectively. This ensures that the QMS is aligned with the organization's strategic direction and is capable of consistently delivering the intended results.

 

Clause 7 – Support

Clause 7 ensures that the organization has the right resources, clear communication channels, and controlled documentation to support its QMS and its operations. This provides a solid foundation for the operational activities covered in the next clause.

 

Clause 8 – Operation

Clause 8 describes the operational activities, from planning and design to production and handling nonconformances, that an organization must manage to ensure the consistent production of safe and effective pharmaceutical products.

 

Clause 9 – Performance evaluation

Clause 9 requires the organization to actively monitor its QMS performance, conduct internal audits to identify areas for improvement, and regularly review the system's effectiveness at the management level.

 

Clause 10 – Improvement

Clause 10 sets out requirements for the organization to proactively identify and address nonconformities, implement corrective actions to prevent recurrence, and actively pursue continual improvement of its QMS.

 

How long will your ISO 15378 certificate be valid for?

Your ISO 15378 certificate will be valid for at least three years; dependent on the type of site that is being certified.  

 

Ready to get started? Apply using the quotation link below.