ISO 15378
Health & Medical Device
Primary packaging materials for medicinal products
ISO 15378:2017 is a standard for primary packaging materials for medicinal products and also non-accredited standard developed to prove a quality management system to an organizations who supply materials. Primary packaging materials are packaging materials that directly contact the contents such as pharmaceuticals, medical devices and cosmetics. It includes glass, plastic, rubber, and aluminum.
The requirements of ISO 9001 and the requirements of GMP (Good Manufacturing Practice) must be applied. The requirements is integrated with GMP principles for design, manufacture and supply and quality management systems. The realization of GMP principles in the management of primary packaging within an organization is very important for the safety of patients using pharmaceuticals that come in direct contact with the materials.
In order to obtain ISO 15378:2017 certification, the following must be complied.
- Compliance with legal regulations
- Identification, reduction and control of risks, including contamination and manufacturing errors
- Approach for effective monitoring of the system
- Provide continuous improvement for overall products and processes
ISO 15378:2017 Requirements
Requirements
The ISO 15378:2017 consists of the same 10 high-level structures,
and must consistently meet the requirements of the clients including the requirements of the relevant standards and international standards.
The ISO 15378:2017 consists of 10 chapters and 4 appendices. Manufacturers who understand and implement the quality management system can also obtain ISO 15378 certification through understanding and reflection of additional requirements.
Scope
· 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.
Additional requirements except ISO 9001:2015
The ISO 15378:2017 consists of 10 chapters and 4 appendices.
|Manufacturers who understand and implement the quality management system can also obtain ISO 15378 certification through understanding and reflection of additional requirements.
※ Click the button to see additional requirements.
ISO The importance of ISO 15378
Certification for primary packaging materials that apply the requirements of GMP and quality management systems is recognized worldwide. Primary packaging materials in direct contact with medicinal products is especially important. Because It is directly related to the health of people or animals using pharmaceuticals.
The advantages of ISO 15378 certification are as follows
1
It can reduce costs by minimizing contamination, mixing and manufacturing errors and waste in manufacturing and improving productivity.
2
By providing guidance on risk management and validation, you can mitigate the risks identified as contamination in your products, and ensure product efficacy and shelf life.
3
By complying with GMP requirements in accordance with the ISO 15378:2017, you can improve your production process proficiency.
4
By producing products in compliance with the requirements of the quality management system and GMP requirements, high-quality products are guaranteed and this can lead to improved clients' satisfaction, and can establish optimized quality management system requirements.
5
It can help protect your brand by enhancing your organization's value with key stakeholders and ensure the quality and stability of your organization.
6
It helps organizations effectively manage risk by helping organizations identify, control and manage risks throughout the ISO 15378 audit process.
IGC’s Competency
· IGC has been accredited for ISO 13485 by UAF, KAB, an Accreditation Body in the United States, and provides certification services for quality management systems.
· The auditors of IGC are contributing to the continuous development of customers by accurately assessing the suitability of the medical device quality management system through the technology and expertise accumulated over the years.
· As a trusted global leader in management system certification, IGC offers ISO 9001 and ISO 13485 certification as well as environmental management and other management systems.
· IGC has up-to-date knowledge of a wide range of specific scopes and legal requirements in major markets around the world, and provides the knowledge and services to support your entire global operation.
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