ISO 15378 Primary Packaging Certificate for Medicinal Products

What Is ISO 15378?

ISO 15378 is the international standard that defines the requirements for primary packaging of medicinal products. The standard defines the quality management system for the packaging materials and processes used in the pharmaceutical industry. ISO 15378 certification proves that primary packaging manufacturers and medicinal product manufacturers are providing packaging that meets the quality and safety standards.

ISO 15378 is built on the ISO 9001 Quality Management System and addresses hygiene, safety, and traceability during the production, storage, and distribution of medicinal products. The standard requires primary packaging manufacturers to meet customer demand, secure product safety, and meet regulatory compliance.

ISO 15378 certification confirms that primary packaging manufacturers meet specific requirements such as:

Conformity with Good Manufacturing Practice (GMP) principles.
Quality control and traceability in the production process.
Defining sterilisation and cleaning methods for products.
Developing risk management and process improvement strategies.
Defining material selection, storage, and transport conditions.
Hygiene and cleaning measures during the packaging process.

ISO 15378 certification lifts credibility on the safety, quality, and conformity of medicinal products. Meeting the standard in medicinal product packaging is a real step toward delivering a reliable product to consumers and healthcare professionals.

Why Eurocert for ISO 15378 Certification?

Eurocert is a certification body to consider for ISO 15378 certification. Reasons to pick Eurocert include:

International recognition: Eurocert is a certification body recognised and accepted internationally. Holding a Eurocert certificate proves your business's conformity to ISO 15378 requirements and the conformity of your quality management systems.
Expertise and experience: Eurocert specialises in medicinal product packaging and quality management. We field experienced specialists during certification and bring knowledge of how to interpret and apply ISO 15378 requirements.
Customer-focused approach: Eurocert puts customer satisfaction first. We listen to a business's needs, provide solutions shaped around the operation, and guide businesses through certification with a customer-focused approach.
Fast, effective service: Eurocert works to run the certification process quickly and efficiently. We make sure every step, from application through audit to certificate issuance, is completed on time.
Strong communication: Eurocert communicates effectively with businesses, keeps them informed about the process, and answers questions. Working with businesses, we keep the certification process running smoothly.

For these reasons, choosing Eurocert for ISO 15378 certification is a strong option for verifying conformity to ISO 15378, strengthening quality management systems, and securing the quality and reliability of medicinal product packaging.

What Are the Core Requirements of ISO 15378?

The core requirements of ISO 15378 are:

Quality management system: ISO 15378 requires primary packaging manufacturers to comply with the ISO 9001 Quality Management System. The system is a documented quality management system that includes continuous-improvement principles.
Risk management: ISO 15378 requires primary packaging manufacturers to set up and apply risk management processes. That includes building a process to identify, assess, and reduce potential risks.
Traceability: the standard requires primary packaging manufacturers to make their production processes traceable. That is achieved through product serialisation, traceability systems, and recordkeeping.
Material selection and control: ISO 15378 covers the selection and control of materials used by primary packaging manufacturers. Materials are assessed for suitability and safety, meet the quality standards, and are stored under the right conditions.
Hygiene and cleaning: the standard requires primary packaging manufacturers to take hygiene and cleaning measures. Topics like production environment cleanliness, personnel hygiene, and sterilisation requirements are addressed.
Documentation and authorisation: ISO 15378 requires primary packaging manufacturers to document their production processes and apply authorisation procedures. Production processes and product conformity are audited and documented regularly.

These core requirements cover the key steps for meeting ISO 15378. They include the elements that matter for securing the safety, quality, and conformity of medicinal products.

How to Get the ISO 15378 Certificate

To obtain the ISO 15378 certificate, follow these steps:

Learn about the standard: before pursuing ISO 15378, getting detailed information about the standard matters. To understand the requirements and certification process, draw on the ISO official website or the relevant certification bodies.
Choose a certification body: to obtain the ISO 15378 certificate, select a certification body. The body runs the certification process and assesses you against ISO 15378 requirements. Choosing a credible body matters for the certificate's reputation and acceptance.
Apply: submit an application to the certification body. The application process involves notifying the body that you are requesting certification services and pursuing ISO 15378. At this stage, you can get information on the certification process and costs.
Certification process: the certification body assesses your business against ISO 15378 requirements and audits it. The process includes a series of audits and reviews by the body. Production processes, the quality management system, traceability, risk management, and other requirements are assessed.
Verification and correction: if the audits identify gaps or nonconformities, the certification body provides corrective action plans. At this stage, you take the corrective actions required to close the gaps. The body re-audits to verify that the gaps have been closed.
Certification: once the relevant processes are complete and conformity to ISO 15378 is confirmed, the certification body issues the ISO 15378 certificate. The certificate documents that, as a primary packaging manufacturer, you meet ISO 15378 standards and the requirements for the quality and safety of medicinal products.

The process for obtaining ISO 15378 can be complex and varies with the specific requirements of the certification body. Contacting the body and getting detailed information matters.

ISO 15378 Cost

The certification process and pricing for ISO 15378 vary by certification body and by the characteristics of the business. The price is set based on several factors and can include:

Business size: the size of your business, headcount, production volume, and the complexity of facilities can affect the price. Larger businesses typically need a more complex certification process and may face higher costs.
Process complexity: the complexity of the processes required for ISO 15378 and the state of the business's existing quality management system documentation can affect certification cost. Certifying complex, detailed processes calls for more resources and work.
Number of audits: the number of audits run for ISO 15378 certification also affects cost. The application process can involve different audit phases, such as preliminary audits and main audits. Each audit phase can be priced based on the certification body's resources and time.
Certification body: different certification bodies can have different pricing policies. The body's reputation, experience, and service quality can also be factors that affect price.

For an ISO 15378 quote and to determine the cost of the certification process, we recommend contacting Eurocert directly.

Benefits of ISO 15378

ISO 15378 provides a set of benefits for primary packaging manufacturers and medicinal product manufacturers, including:

Quality assurance: conformity to ISO 15378 secures the quality and reliability of primary packaging. That confirms proper protection, integrity, and effectiveness for medicinal products. Quality management systems and processes that meet the requirements give customers assurance and show that products meet quality standards.
Legal compliance: ISO 15378 requires primary packaging manufacturers to meet the relevant legal requirements. Conformity to all national and international regulations that apply to the packaging and distribution of medicinal products reduces legal risk and secures legal compliance.
Consumer trust: ISO 15378 lifts consumer trust. When consumers have concerns about the safety, integrity, and conformity of medicinal products, the ISO 15378 certificate provides a signal that they can use the products of certified primary packaging manufacturers with confidence.
Competitive edge: ISO 15378 provides primary packaging manufacturers with a competitive edge. The certificate sets the manufacturer apart from competitors and shows the lead it has on quality, safety, and conformity. Customers prefer to work with primary packaging manufacturers that meet the quality management standards.
Improved business processes: obtaining ISO 15378 lets primary packaging manufacturers review and improve their business processes. The standard encourages the application of effective processes and quality management principles. The result is higher efficiency, fewer errors, and lower costs.
International recognition: ISO 15378 is recognised and accepted internationally. The certificate helps primary packaging manufacturers compete in international markets and eases the export of medicinal products.

The benefits of ISO 15378 lift the reputation of primary packaging manufacturers in the medicinal product industry on quality, safety, and conformity, and give customers confidence.

ISO 15378 Primary Packaging Materials for Medicinal Products

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