ISO 15378 Certification - Primary Packaging Regulatory
ISO 15378药品的主要包装材料
ISO 15378 Certification is a quality assurance for primary packaging materials for medical products specific prerequisites for the utilization of ISO 9001:2008, with reference to GMP. In 2006, the procedure-oriented ISO 15378 standard was delivered. In view of the globally acknowledged ISO 9001 quality standard, it contains all the GMP essentials appropriate to primary packaging material, for example, batch tracing, risk management, validation, and controlled environment.
What is ISO 15378 Certification ?
- ISO 15378：2017标准表示对质量管理系统的要求，在该系统中，组织需要显示其为药品提供主要包装材料的能力，这些产品可靠地满足客户要求，包括监管要求和与主要包装药物有关的国际标准
- An ISO 15378:2017 certificate with its wholistic way to deal with GMP and quality necessities is perceived all through the world. It delivers manufacturers of primary packaging materials with an appropriate capability for customer approval – just as improving the organization’s image according to the authorities. ISO 15378:2017 applies to all manufacturers of packaging materials that come into direct contact with the medical products. The standard covers all the typical materials, such as glass, rubber, aluminum, and plastics.
- This ISO standard is currently lined up with ISO 9001:2015 and has same 10 elements high-level structure. ISO 15378:2017 determines necessities for a quality management system where an association needs to exhibit its capacity to deliver primary packaging materials for medicinal products, which reliably meet customer requirements, including regulatory prerequisites and International Standards pertinent to primary packaging materials.
- 目的是通过有效使用系统来提高客户满意度，包括用于开发系统的过程以及确认对客户以及材料法定和监管必需品的合规性。
- The primary packaging material is identified as the material that is in direct contact with the measurement structure. With the involvement in Primary packaging standard which may require any single part of a container closure system which includes containers, container liners, closures, closure liners, stopper oversells, etc.
ISO 15378 Benefits
- ISO 15378 Standard has strategic tools that reduce costs by minimizing waste and manufacturing errors and increasing productivity.
- 它鼓励组织得到to new markets and encourage free and reasonable worldwide exchange.
- The manufacturer can improve their proficiency of production processes by following GMP standards according to ISO 15378 standard.
- To relieve your risks particularly identified with product contamination, mix-ups and errors and ensure product efficacy and shelf life.
- 向客户保证优质产品。升级客户满意度。
- 比其他未确认的提供商的竞争优势。
- 风险管理的应用有助于减少与产品相关的错误。
ISO 15378的应用
- ISO 15378:2017 is an application standard for the structure, manufacture and supply of primary packaging material for the medicinal product.
- It is additionally appropriate for certification purposes of primary packaging material for medicinal products in pharmaceuticals and medical device industries. This primary packaging standard discovers Good manufacturing practice (GMP) standards and Quality Management System relevant to primary packaging materials for medicinal products.
- ISO 15378 can be utilized for quality improvement, training, auditing and certification.
- ISO 15378标准每5年进行评估。
188金宝搏网站靠谱吗操纵子战略家helps manufacturers develop their质量管理体系as per the requirements of ISO 15378. We assist with documentation, training & implementation of the quality system. We help the Primary packaging material manufacturers to understand the requirements of ISO 15378 by performing GAP analysis and implementing QMS and GMP requirements as per ISO 15378:2017. As188金宝慱亚洲体育医疗设备咨询公司we support the manufacturers of primary packaging materials for the medicinal product to enhance their QMS system by addressing specific requirements to meet the quality objectives as per ISO 15378 certification. Operon Strategist assist the pharmaceutical and medical device industries to assess their suppliers of primary packaging materials and increase overall product quality.