The ISO 15378:2017 – Primary Packaging Materials for Medicinal products was developed by stakeholders in the medicinal sector to provide a quality management system (QMS) for suppliers of materials intended to be used as packaging for medicinal products. Published in 2006, the process-oriented ISO 15378 standard picks up this idea. Based on the internationally accepted ISO 9001 quality standard, it covers all the GMP requirements relevant to primary packaging material, such as batch tracing, risk management, validation, and controlled environment. In medicines and medical device industries, the ISO 15378:2017 certification purposes of primary packaging material for medicinal products.
The ISO 15378 Certification with its approach to GMP and quality requirements is recognized throughout the world. It delivers manufacturers of primary packaging materials with a suitable qualification for customer approval – as well as improving the organization’s image in the eyes of the authorities. ISO 15378:2017 applies to all manufacturers of packaging materials that come into direct connection with the medicinal products. The standard covers usual materials, such as glass, rubber, aluminum, and plastics.
ISO 15378:2017 specifies requirements for a quality management system where an organization needs to prove its ability to provide primary packaging materials for medicinal products, which constantly meet customer requirements, including regulatory requirements and International Standards appropriate to primary packaging materials. The ISO 15378:2017 standard contains several important QMS guidelines for primary manufacturers of glass, plastic, rubber, aluminum and other materials used for medicinal packaging, including:
- Compliance to legal requirements.
- Identification, decrease and control of risks including contamination and manufacturing errors.
- Enhanced efficiency and cost-effectiveness in operation.
- Process Approach for monitoring effectiveness of the system.
- Provision for Constant Improvement of Processes for overall improvements in products and processes.
Benefits of ISO 15378:
- Standards are strategic tools that decrease costs by minimizing waste and manufacturing errors and growing productivity.
- It helps businesses to access new markets, levels the playing field for developing countries and facilitates free and fair global trade.
- The creator can boost the competence of their production processes by following GMP principles as per this standard.
- To mitigate risks specially related to product contamination, mix-ups, and errors and confirm product efficacy and shelf life.
- Declares implementation of GMP Principals in Manufacturing of Pharmaceutical and Medical Device Packaging Material.
- Competitive Advantage completed other non-certified suppliers.
- It helps to Development in processes.
- Minimization or elimination instances of contamination.
Who should get ISO 15378 Certified?
- Any organization offering products or services seeking a generally accepted quality assurance system for primary drug packaging should be ISO 15378: 2017 certified.
- Any installation must declare ISO 15378 certification to guarantee customers of its quality systems.
- Any facility wishes that the interests of all stakeholders are taken into account in its system and should achieve ISO 15378 certification due to adequate provisions to decrease risk in their processes.
- Any installation desiring a powerful marketing tool to present its quality abilities must obtain ISO certification.
- Any organization wants to have a complete system to cover all aspects of operations in a single management control system must be ISO certified.
- ISO 15378 certification is essential for any organization whose management aspires to a single system that permits it to provide teamwork, review progress, measure, control, correct and provide the necessary incentives for continuous improvement.