[ Certification Introduction ]

The ISO 15378:2017 standard identifies the GMP principles and specifies the requirements of Quality Management Systems that apply to the primary packaging of medicines and medical devices. This international standard applies to the primary packaging materials of a drug and it means packaging materials that come in direct contact with contents such as medical devices, drugs, and cosmetics. (Ex. Glass, rubber, plastic, aluminum, film, foil and coating containers, etc.)

This standard shall apply the requirements of ISO 9001 (Quality Management System) and the requirements of Good Manufacturing Practice (GMP), based on the Quality Management Principles described in ISO 9000.

[ ISO 15378:2017 Scope ]

• Materials of medicines primary packaging materials and containers (e.g., Pill packaging materials, Medicine storage containers)

• Cosmetic packaging materials and materials (e.g., Perfume bottles, Skin storage containers, Mask pack packaging materials, etc.)

  • •  If it is necessary to demonstrate the organization's ability to provide primary packaging for medicinal products, the requirements for the quality management system should be specified.
  • •  This standard is applied to the design, manufacture and supply of primary packaging materials for medicinal products, and this standard can also be used for certification purposes.
  • •  All requirements of this standard are general, developed to be applicable to all organizations regardless of product, and if the requirements of the standard cannot be applied to the organization and product, its provisions can be excluded.

[ Related standards with ISO 15378:2017 ]

• •  ISO 9001:2015 (Quality Management System)
• •  ISO 31000:2018 (Risk management — Guidelines)
• •  ISO 22716:2007 (Cosmetics — Good Manufacturing Practices (GMP) — Guidelines on Good Manufacturing Practices)

[ ISO 15378:2017 Requirements ]

ISO 15378:2017 standard introduces High-Level Structures (HLS), and references ISO 14971:2019, (Medical device risk management guidelines), ISO 11135:2014, ISO 11137:2006, ISO 14937:2009.

To ensure consistently requirements of customers by including the requirements of the relevant standards and international standards. In the case of cosmetic packaging materials, it is the foundation for determining the application level of the requirements based on risk.

• Scope
• Normative references
• Terms and definitions
• Context of the organization
• Leadership
• Planning
• Support
• Operation
• Performance evaluation
• Improvement

[ The importance of ISO 15378:2017 ]

• 1. It can guarantee the quality and safety of the primary packaging materials of medicines/cosmetics.
• 2. ISO 15378:2017 standards enable manufacturers to meet the legal requirements of primary packaging materials for medicines and medical devices.
• 3. It helps reduce the risk of safety risk factors and product contamination, ensuring product’s effectiveness and shelf life.
• 4. This standard that is about primary packaging materials that apply the requirements of the GMP and quality management system is recognized worldwide.
• 5. The primary packaging material in direct contact with the medicine is directly related to the health of the animal, in addition to the person using the drug, so importance is more highlighted.

[ The effect of ISO 15378:2017 ]

• •  To gain an edge in competition with other competitors by Increasing brand and company image as well as quality reliability about manufacturers.
• •  Active response to the cGMP requirement (Supplier qualification) is possible.
• •  Reduce the cost of failure by minimizing risk through documented criteria.
• •  Through the process of ensuring compliance with customer requirements including continuous improvement, the Quality Management System's effective application can improve customer satisfaction and secure overseas customers.