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ISO 15378:2017

Quality of Pharmaceutical Packaging Materials

Safe packaging... protected medicine... guaranteed healing

Certifiable Standard

ISO 15378:2017

Safe packaging... protected medicine... guaranteed healing

Standard definition

ISO 15378:2017 is the specialized standard for pharmaceutical packaging materials quality, ensuring drug protection from contamination and damage, maintaining their efficacy and safety, and contributing to safe treatment delivery to patients worldwide.

Why it matters

Because the global pharmaceutical packaging market is worth $137 billion, and 30% of counterfeit drugs result from poor packaging. Standard implementation achieves: complete drug protection, regulatory standards compliance, increased pharmaceutical company trust, opening new markets, risk reduction.

Benefits

  • Complete drug protection from contamination and damage
  • compliance with all global regulatory standards
  • 85% increase in pharmaceutical company trust
  • opening new profitable markets
  • reduced recall and fine risks
  • enhanced reputation and credibility
  • increased revenue

Applicable organizations

  • Essential for all pharmaceutical packaging material manufacturers: bottle and vial manufacturers
  • capsule and tablet manufacturers
  • bag and box manufacturers
  • syringe and ampoule manufacturers
  • pharmaceutical label manufacturers
  • raw material suppliers.

Application scope

  • The standard covers all pharmaceutical packaging materials: primary containers (vials
  • ampoules
  • syringes)
  • secondary packaging (boxes
  • cartons)
  • closure materials (caps
  • stoppers)
  • labels and printing
  • sterilization materials
  • quality assurance.

Assdaf methodology

  • At Assdaf
  • we believe that every pharmaceutical package carries hope for healing. Our methodology includes: comprehensive manufacturing process assessment
  • developing integrated quality system
  • implementing strict hygiene controls
  • training specialized teams
  • continuous quality monitoring
  • continuous improvement.

Certification benefits

  • Assdaf your partner in protecting medicine and ensuring its safe delivery to patients. We transform your factory into a global reference for quality and safety in pharmaceutical packaging. Safe packaging
  • protected medicine
  • guaranteed trust
  • sustainable growth.

Start Your Implementation Journey with Assdaf

We can support you with assessment, qualification, training, and certification readiness.