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ISO 15378 Primary Packaging Materials

ISO15378 (Primary packaging materials for medicinal products - Particular requirements for the application of IS0 9001 : 2015) Overview

It is based on ISO 9001 (Quality Management System) as a Good Manufacturing Practice (GMP) for cosmetics containers and drug direct containers and is a certification standard required for manufacturers of cosmetics containers (vials, ampoules, etc.).
ISO15378 (Primary packaging materials for medicinal products - Particular requirements for the application of IS0 9001 : 2015) Feature and backgrounds
The ISO15378 standard stipulates the requirements for a quality management system (ISO9001) that can be applied to primary packaging materials for medicines in principle. The ISO15378 standard, which is usually applied to cosmetics packaging materials, is a packaging material standard that requires a considerable level of applicability to be applied for primary packaging materials used in medicines. This is because the original application is not cosmetic packaging materials, but pharmaceutical packaging materials. Since there is a significant difference in the safety level of pharmaceuticals and cosmetics products, it can be understood as the difference between ISO22716's cosmetic GMP standard and the pharmaceutical GMP standard. The original purpose of ISO 15378 is to ensure the safety of patients using direct contact with medicines by realizing the GMP principles for the production and management of primary packaging materials within the organization. Therefore, in the case of cosmetic packaging materials, the application level of the relevant requirements should be determined based on the risk of cosmetic packaging materials, and the application of the quality management system and GMP should be established.

ISO15378 (Primary packaging materials for medicinal products - Particular requirements for the application of IS0 9001 : 2015) Contents

No. Title
4 Context of the organization
4.1 Understanding the organization and its context
4.2 Understanding the needs and expectations of interested parties
4.3 Determining the scope of the quality management system
4.4 Quality management system and its processes
5 Leadership
5.1 Leadership and commitment
5.2 Policy
5.3 Organizational roles, responsibilities and authorities
6 Planning
6.1 Actions to address risks and opportunities
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes
7 Support
7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented Information
8 Operation
8.1 Operational planning and control
8.2 Requirements for products and services
8.3 Design and development of products and services
8.4 Control of externally provided processes, products and services
8.5 Production and service provision
8.6 Release of products and services
8.7 Control of nonconforming outputs
9 Performance Evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.2 Internal audit
9.3 Management review
10 Improvement
10.1 General
10.2 Nonconformity and corrective action
10.3 Continual improvement

ISO15378 (Primary packaging materials for medicinal products - Particular requirements for the application of IS0 9001 : 2015) Introduction Effectiveness and Necessity

  • It is possible to establish an advanced manufacturing and quality management system for production of cosmetics containers, acquire a quality competitive advantage over other competitors, and provide quality reliability to cosmetics manufacturers. It also enables active response to CGMP requirements, Supplier qualification, minimizes risk through documented criteria, and helps secure overseas clients.
The U.S Certification Body is constantly striving to become a company of client satisfaction by securing sincere and experienced judges so that domestic and foreign companies can implement the introduction of ISO 15378, which is internationally recognized. In addition, through the ISO 15378 program of the U.S. Certification Institute, you can pioneer the global market by improving international awareness and improve marketability by satisfying requirements and improving product reliability.