ISO 15378

ISO 15378



[What is ISO 15378?]


ISO 15378 is the regulation which is non-accredited regulations that apply the requirements of ISO 9001 and GMP Requirements for primary packaging materials for medicines


*(The Primary Packaging materials directly contact with the contents of medicines, medical devices and cosmetics.)


The primary packaging makes direct contact with the contents of the product, so you can say it’s very important for patient safety.

Therefore, it is necessary to demonstrate the excellence of the quality of the product through certification of primary packaging materials and to demonstrate the safety management.



[The Advantage of ISO 15378]

  • Reduce costs by minimizing contamination, mixing and manufacturing errors, waste, and productivity.
  • By providing guidance on risk management and verification, you can mitigate the risks identified by contamination, mixing and error of the product and ensure product efficacy and validity.
  • Comply with the GMP standard according to ISO 15378 standards and can improve the production process skills.
  • By producing products in compliance with standards and GMP requirements, we guarantee high-quality products and this can lead to improved customer satisfaction. The ISO 15378 specification includes the ISO 9001:2015 version of the standard and includes the requirements of GMP and primary packaging materials to optimize the implementation of the quality management system requirements.
  • Protect your brand by improving your organization's brand and image with key stakeholders and helping ensure the quality and reliability of your organization.
  • It helps organizations identify, control, and manage risks throughout the ISO 15378 screening process to help them manage risks efficiently.




[ISO 15378 Scope]

  1. ISO 15378 is an applicable standard for the design, manufacture and supply of primary materials for medicinal products.
  2. Where it is necessary to demonstrate the organization's ability to provide primary packaging materials for medicines, the requirements for quality management systems should be specified.
  3. All requirements of this specification are general, and are developed to be applicable to any organization regardless of the product, and may be excluded if the requirements of the specification are not applicable to the organization and the product.



[ISO 15378 Key Requirements]

  • Risk assessments should be performed, including risk management, in all processes.
  • The working environment should be maintained and managed to prevent product contamination.
    • Sanitary management regulations should be established, work environment conditions defined and monitored.
    • The clean room shall be maintained based on ISO 14644.
    • Insects and preserves must be managed.
    • Management of supporting facilities and materials is required and risk assessment is required.
  • Training on GMP awareness, procedures and policies should be conducted on a regular basis.
  • Changes should be notified to the customer and customer requirements for disposal of waste packaging should be documented.
  • In case of design changes, customers and authorities should be notified in advance and the validation of the changes should be carried out.
  • Draw up a manufacturing record by manufacturing number and maintain the equipment cleaning and maintenance records.