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ISO 15378 standard specifies requirements for quality management system and references the Good Manufacturing Practice (GMP) requirements, applicable to primary packaging materials where a company needs to demonstrate the ability to provide primary packaging materials for medicinal products which must conform to customer and regulatory requirements as well as global best packaging practice. URS conducts assessment and certify organizations against ISO 15378 standard .
The ISO 15378 standard is an integrated approach of quality management system and GMP requirement to reduce the risks of safety hazards and product contamination, and ensure product efficacy and shelf life. ISO 15378 is applicable to the design, manufacture and supply of the primary packaging material such as glass, plastic, rubber, aluminum, films, foils and laminate containers and other materials. Such manufactures and suppliers needs to demonstrate and comply with safety and reliability requirements to meet expected quality levels with the integration of quality management systems (QMS) and good manufacturing practice (GMP) in their production processes.