What Is The Importance Of Iso 15378 Primary Packaging Materials For Medicinal Products?

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The ISO 15378:2017 is an international standard of Primary Packaging Materials for Medicinal products was established by stakeholders in the pharmaceutical sector to deliver a Quality Management System (QMS) for dealers of materials proposed to be used as packaging for medicinal products. This ISO 15378 Standard classifies Good Manufacturing Practice (GMP) principles and specifies requirements for a quality management system appropriate to primary packaging materials for medicinal products. The recognition of GMP principles in production and control of primary packaging materials within organizations is of great significance for the safety of a patient using the medicinal product, because of their direct product contact. The application of GMP for pharmaceutical packaging materials helps confirm that these materials meet the requirements of the pharmaceutical industry.
ISO 15378 certification with its holistic approach to GMP and quality requirements, is recognized throughout the world. It delivers manufacturers of primary packaging materials with an appropriate qualification for consumer approval – as well as refining ...
... the organization’s image in the eyes of the authorities. ISO 15378 standard executes to all manufacturers of packaging materials that come into direct contact with the medicinal products. The ISO 15378 standard covers all the normal materials, such as glass, rubber, aluminum, and plastics. This standard is now associated with ISO 15378. The ISO 15378:2017 standard specifies requirements for a quality management system where an organization wants to prove its capability to deliver primary packaging materials for medicinal products, which constantly meet consumer requirements, with regulatory requirements and International Standards appropriate to primary packaging materials.
This ISO 15378:2017 standard, established with the participation of pharmaceutical sector experts, incorporates in a single document the quality management requirements of ISO 15378:2015 together with the Principles of Good Manufacturing Practice for the design, manufacturing, and supply of primary packaging materials for medicinal products. The ISO 15378:2017 standard contains some important QMS guidelines for primary manufacturers of glass, plastic, rubber, aluminum and other materials used for medicinal packaging, including:
• Obedience to legal requirements.
• Identification, decrease and control of risks with contamination and manufacturing errors.
• Enhanced efficiency and cost-effectiveness in operation.
• Procedure Approach for monitoring effectiveness of the system.
• Provision for Constant Improvement of Processes for complete enhancements in products and processes.
Importance of ISO 15378 Primary Packaging Materials for Medicinal products:
• It can assurance the quality and safety of the primary packaging materials of medicines.
• ISO 15378:2017 standards allow manufacturers to meet the legal requirements of primary packaging materials for medicines and medical devices.
• It helps to decrease the risk of safety risk factors and product contamination, confirming product’s effectiveness and shelf life.
• This standard that is about primary packaging materials that apply the necessities of the GMP and quality management system is known worldwide.
• The primary packaging material in straight contact with the medicine is straight connected to the health of the animal, in addition to the person using the drug.
What is the effect of ISO 15378:2017?
• To gain an advantage in competition with other competitors by Growing brand and company image as well as quality reliability about manufacturers.
• Active response to the GMP requirement is possible.
• Decrease the cost of failure by minimizing risk through ISO 15378 documents criteria.
• Through the process of confirming compliance with consumer requirements with constant improvement, the Quality Management System's effective application can improve consumer satisfaction and secure overseas consumers.
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