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 standard indicates requirements for a quality management system where an organization needs to show its capacity to give primary packaging materials for medicinal products, which reliably meet customer requirements, including regulatory requirements and International Standards relevant to primary packaging medicinal materials
- 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.
- Objective to upgrade customer satisfaction through the effective use of the system, including processes for the development of the system and the confirmation of conformity to client and material statutory and regulatory necessities.
- 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.
Looking Forward To primary packaging Process For Medical Devices ?
Operon Strategist provides worldwide packaging consultants services to the primary packaging and pharma industries, including strategic, regulatory and environmental
Read MoreISO 15378 Benefits
- ISO 15378 Standard has strategic tools that reduce costs by minimizing waste and manufacturing errors and increasing productivity.
- It encourages organizations to get 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.
- 为了减轻产品污染，混合和错误的尤其确定的风险，并确保产品功效和保质期。
- 向客户保证优质产品。升级客户满意度。
- Competitive Advantage over other non- confirmed providers.
- Application of risk management helps to reduce errors associated with the product.
Application of ISO 15378
- ISO 15378：2017是用于药用产品的主要包装材料结构，制造和供应的应用标准。
- 此外，它还适合于药品和医疗设备行业中的药品主要包装材料的认证。该主要包装标准发现了与药品主要包装材料相关的良好制造实践（GMP）标准和质量管理系统。
- ISO 15378可用于质量改进，培训，审计和认证。
- ISO 15378标准每5年进行评估。
Operon Strategist helps manufacturers develop their quality management system as per the requirements of ISO 15378. We assist with documentation, training & implementation of the quality system.We helpthe 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. Operon Strategist支持初级包装垫的厂家erials 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协助制药和医疗设备行业评估其主要包装材料的供应商并提高整体产品质量。