Clients

  • Dodhys Medical Ltd.
  • Rely BTL Production & Services
  • AKG Engineering & Construction Group
  • Consulting Key Management (CKM)
  • ACA Alliance
  • Elecnor S.A. Co. Abu Dhabi
  • Hadid International Services FZE
  • ALMADION International LLC
  • Qatari Industrial Equipment WLL
  • Beaver Gulf Group

ISO 15378:2011 Certification
Home - We Certify - ISO 15378:2011 Primary Packaging GMP

This standard 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.

ISO 15378:2011 is an application standard specifically for the design, manufacture and supply of primary packaging materials for medicinal products.

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Certifications

  • ISO 9001 -
    Quality Management
  • ISO 50001-
    Energy Management
  • ISO 9001-
    Quality Management for Small Businesses
  • ISO 28000 Security- Management for the Supply Chain
  • ISO 14001-Environmental Management
  • ISO 13485-
    Medical Devices
  • OHSAS 18001- Occupational Health and Safety
  • ISO 80079- Equipment for Explosive Areas
  • ISO 22000-
    Food Safety
  • ISO 3834-
    Welding Technical Requirements
  • ISO 9004-
    QMS Performance Improvement
  • EN 15224-
    Health Care
  • ISO 10002-
    Customer Satisfaction
  • GxP HACCP-
    Hygiene in Practices
  • ISO 10006-
    QM Management in Projects
  • HACCP-
    Hygiene in Practices
  • ÖNR 49001-
    Risk Management
  • WHO-
    HACCP Food
  • ISO 12100-
    Safety of Machinery
  • 2012/83/EC-
    Good Sales Practice GDP
  • ISO 15378-
    Primary Packaging GMP
  • GMP-
    Good manufacturing Practice
  • ISO 22716 -Cosmetics GMP
  • EN 15221-
    Facility Management
  • ISO 26000-
    Social Responsibility
  • EU 333/2011-Criteria for Scrap Down
  • SA 8000-
    Social Accountability System Certification
  • CE Marking

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