• ISO 9001
    Quality Management System

  • ISO 14001
    Environmental Management System

  • ISO 22000
    Food Safety Management System

  • OHSAS 18001
    Occupational Health & Safety Management System

  • ISO and Technical Training


ISO 15378 ( ISO Consultancy )
Primary Packaging Materials for Medicinal Products


ISO 15378 is an international accepted standard for Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) applicable to all manufacturers of packaging materials that comes into direct contact with the medicinal products, e.g. glass, rubber, aluminium and plastics.

The requirements of controlled processes in manufacturing of primary packaging for pharmaceutical products and great care to be taken during production due to the many different risks of contamination has been standarised in ISO 15378. The standard sets out what is required in respect of a quality management system and how the requirements apply to the packaging materials for medicinal products.

QSS will assists organization in establishing, documenting and implementing ISO 15378 or if organization already certified to ISO 9001 than performing GAP analysis and implementing quality management system and Good Manufacturing Practices (GMP) requirements relevant to primary packaging materials such as tracing, risk management, validation and controlled environment as per ISO 15378.

ISO 15378 ( ISO Consultancy ) Primary Packaging Materials for Medicinal Products
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