ISO 15378 Certification ensures the highest quality standards for manufacturers of primary packaging materials for medicinal products, incorporating the critical ISO 15378 guidelines and Good Manufacturing Practices (GMP). At Operon Strategist, a leading medical device regulatory consultancy, we simplify the process of obtaining ISO 15378 certification, ensuring compliance with regulatory and customer requirements.

Introduced in 2006, the ISO 15378 standard is based on the internationally recognized ISO 9001 quality framework. It includes GMP requirements essential for primary packaging materials, such as batch tracing, risk management, validation, and controlled environments, ensuring product safety and quality.

What is ISO 15378 QMS Certification? 

  • The ISO 15378:2017 standard specifies requirements for a Quality Management System (QMS) where organizations must demonstrate their ability to consistently provide primary packaging materials for medicinal products that meet both regulatory and customer expectations. Achieving ISO 15378 certification means your company complies with international standards, bolstering your reputation and facilitating customer approvals.

    The ISO 15378 guidelines apply to all manufacturers of packaging materials that come into direct contact with medicinal products, including glass, rubber, aluminum, and plastics. The standard is aligned with ISO 9001:2015, ensuring a comprehensive approach to quality management and GMP.

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Key Benefits of ISO 15378 Certification

Implementing the ISO 15378 standard offers several benefits, including:

    • Reducing costs by minimizing waste and production errors while increasing efficiency.
    • Facilitating access to new markets and encouraging international trade.
    • Ensuring adherence to GMP standards, reducing risks related to contamination, product mix-ups, and errors.
    • Enhancing product quality, thereby increasing customer satisfaction.
    • Providing a competitive advantage over non-certified suppliers.
    • Applying risk management practices to prevent errors and ensure the safety of primary packaging materials for medicinal products.

Application of ISO 15378 

  • ISO 15378:2017 is an application standard for the structure, manufacture and supply of primary packaging material for medicinal products. 
  • It is additionally appropriate for certification purposes of primary packaging material for medicinal products in pharmaceuticals and medical device industries. This primary packaging standard discovers good manufacturing practice (GMP) standards and Quality Management System relevant to primary packaging materials for medicinal products. 
  • ISO 15378 can be utilized for quality improvement, training, auditing and certification. 
  • The ISO 15378 standard is assessed every 5 years. 

What will be the Role of Operon Strategist? 

Our team can perform various activities like GAP analysis, QMS implementation and others. After understanding the need of ISO 15378, by performing GAP analysis and QMS we can assist you in creation of documentation and training.

We also provide medical device consultation for India, South Africa, Egypt, the USA, the UK, Costa Rica, Oman, and Iran. For free consultation Contact us now.  

 

How will Operon Strategist help you in ISO 15378? 

At Operon Strategist, we assist manufacturers of primary packaging materials for medicinal products with a full range of services, including GAP analysis, QMS implementation, and GMP compliance. Our team ensures your systems align with ISO 15378:2017 guidelines by addressing all regulatory requirements to meet quality objectives.

Whether you’re located in  India, South Africa, Egypt, the USA, the UK, Costa Rica, Oman, or Iran, we provide expert consultation to help you achieve ISO 15378 certification and enhance your QMS system. Contact us for a free consultation today.