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ICMC (International Certification Management Center Co., Ltd.)

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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.).




ISO 15378 Necessity

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.




Composition of ISO 15378 Requirements

NO Title NO Title
4
Context of the organization
 8
Operation
5
Leadership
9
Performance evaluation
6
Planning
 10
Improvement
7
Support



Effectiveness of introducing ISO 15378

1
Establish an advanced manufacturing and quality management system for cosmetic container production
2
Acquisition of quality competitive advantage over other competitors
3
Providing quality reliability for manufacturing
4
Active response to supplier qualification possible
5
Easy to secure overseas customers


ICMC (International Certification Management Center)
 Global/Domestic RA Consulting & GMP(ISO) Internal Auditor Training

ICMC has been working tirelessly to become a customer-satisfying company by securing experienced and excellent RA consultants and audit instructors as a specialized institution for global/domestic RA consulting & GMP(ISO) internal auditor training for more than 25 years. ICMC will provide consulting services to enable the introduction of an internationally recognized system through skilled professionals. In addition, ICMC will provide training services to respond to domestic GMP and international ISO audits, strengthen practical competencies, and acquire internal audit skills. Through this, through the implementation of the global system, the safety, reliability and quality of products can be improved and international competitiveness can be secured. ICMC provides customized consulting services for global system establishment in the shortest period and minimum cost, as well as education to establish the overall concept and operation method of domestic GMP and global ISO, and will become an essential partner for entering the global market.