Quality of Pharmaceutical Packaging Materials

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

Certifiable Pharmaceutical Packaging Healthcare

Standard Definition

Overview of ISO 15378:2017

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.

Standard Importance

Why is this standard important?

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.

Implementation Benefits

Advantages your organization will gain

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

Target Organizations

Who can implement this standard?

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.

Implementation Scope

How is the standard implemented within the organization?

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

How we help you qualify and obtain certification

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

Additional advantages of obtaining certified accreditation

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.

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Standard Information

Standard Code ISO 15378:2017

Category Medical & Healthcare Sector Systems

Version 2017

Type Certifiable

Family Pharmaceutical Packaging

Sector Healthcare

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Quality of Pharmaceutical Packaging Materials

Standard Definition

Standard Importance

Implementation Benefits

Target Organizations

Implementation Scope

Assdaf Methodology

Certification Benefits

Start Your Certification Journey

Get Custom Quote

Standard Information

Need Additional Help?

Related Standards

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Clinical Investigation of Medical Devices Management

Most Popular Standards

Medical Devices Quality Management System

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Quality of Pharmaceutical Packaging Materials

Standard Definition

Standard Importance

Implementation Benefits

Target Organizations

Implementation Scope

Assdaf Methodology

Certification Benefits

Start Your Certification Journey

Get Custom Quote

Standard Information

Need Additional Help?

Related Standards

Medical Devices Quality Management System

Medical Laboratory Accreditation

Clinical Investigation of Medical Devices Management

Most Popular Standards

Medical Devices Quality Management System

Quality Management System

Information Security Management System

Environmental Management System

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