ISO 15378 Quality Assurance

ISO 15378 Quality Assurance

Quality Assurance: ISO 15378 Primary packaging materials for medicinal products particular requirements for the application of ISO 9001:2008, with reference to GMP.

What is ISO 15378?

  • ISO 15378:2017 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards applicable to primary packaging materials.
  • Aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
  • The primary packaging material is defined as the material that that is in direct contact with the dosage form. Primary packaging may comprise any single part of a container closure system including containers, container liners, closures, closure liners, stopper oversells, etc.

Benefits of ISO 15378

  • Standards have strategic tools that reduce costs by minimizing waste and manufacturing errors and increasing productivity.
  • It helps companies to access new markets and facilitate free and fair global trade.
  • The manufacturer can boost their efficiency of production processes by adhering GMP principles as per this standard.
  • To mitigate your risks especially related to product contamination, mix-ups and errors and ensure product efficacy and shelf life.
  • Assurance of quality products to your clients. Enhance customer satisfaction.
  • Competitive Advantage over other non-certified suppliers.
  • Application of risk management helps to reduce errors associated with the product.

Application of ISO 15378

  • ISO 15378:2017 is an application standard for the design, manufacture and supply of primary packaging material for the medicinal product.
  • It is also applicable for certification purposes of primary packaging material for medicinal products in pharmaceuticals and medical device industries. This standard identifies Good manufacturing practice (GMP) principles and Quality management system applicable to primary packaging materials for medicinal products.
  • ISO 15378 can be used for quality improvement, training, auditing and certification.
  • The ISO 15378 standard is reviewed every 5 years.
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ISO 15378 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meets customer requirements, including regulatory requirements & international standards applicable to primary packaging materials.

Operon Strategist helps manufacturers develop their quality management system as per the requirements of ISO 15378. We help with documentation, training & implementation of the quality system.

We are assisting with the manufacturers of Primary packaging material to understand the requirements of ISO 15378 by performing a GAP analysis, and implementing QMS and GMP requirements as per ISO 15378:2017.

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. We assist the pharmaceutical and medical device industries to assess their suppliers of primary packaging materials and increase overall product quality.