ISO 15378:2017 Primary Packaging Materials for Medical Products Certification

ISO 15378:2017 Primary Packaging Materials for Medical Products Certification – Ensure Safety and Compliance in Pharmaceutical Packaging

What Does ISO 15378 Stand For?

ISO 15378 stands for “Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to Good Manufacturing Practices (GMP)”. It is an international standard developed by the International Organization for Standardization (ISO) to ensure the quality and safety of packaging materials used in the pharmaceutical and medical sectors.

What Is the ISO 15378 Primary Packaging Materials for Medical Products Standard?

The ISO 15378 standard combines ISO 9001 quality management principles with Good Manufacturing Practices (GMP) requirements for manufacturers of primary packaging materials. It covers processes such as design, production, control, and traceability to ensure patient safety and regulatory compliance. By applying ISO 15378, companies reduce contamination risks and guarantee consistent quality in packaging for medical products.

When Was the Latest Version of ISO 15378 Published?

The ISO 15378 standard was first published in 2003 and updated over the years. The latest version, ISO 15378:2017, aligns with ISO 9001:2015 and incorporates updated GMP guidelines for the pharmaceutical packaging industry.

Which Companies and Institutions Should Apply for the ISO 15378:2017 Certificate?

The ISO 15378 Certificate is highly recommended for:
✓ Manufacturers of glass, plastic, aluminum, or rubber packaging for medicines
✓ Pharmaceutical packaging companies
✓ Medical device packaging suppliers
✓ Contract manufacturing organizations (CMOs)
✓ Laboratories testing pharmaceutical packaging
✓ Wholesalers and distributors in healthcare packaging

Any organization producing or handling primary packaging for medical products can benefit from ISO 15378 certification.

Why Is the ISO 15378:2017 Certificate Important for Companies?

For companies, the ISO 15378 Certificate provides:
✓ International recognition of compliance with GMP and ISO 9001
✓ Reduced contamination and defect risks
✓ Stronger compliance with regulatory and client requirements
✓ Increased product safety and reliability
✓ Competitive advantage in the pharmaceutical market

Why Should You Get the ISO 15378 Certificate?

Organizations should obtain the ISO 15378 Certificate to demonstrate their commitment to high-quality, safe, and compliant pharmaceutical packaging. Certification helps secure partnerships with pharmaceutical companies and ensures compliance with strict global regulations.

Which Industries Use the ISO 15378 Certificate?

✓ Pharmaceutical Manufacturing
✓ Biotechnology
✓ Medical Devices
✓ Healthcare Packaging
✓ Laboratories and Testing Services
✓ Wholesalers and Distributors

Any sector involved in pharmaceutical or medical packaging can benefit from ISO 15378 certification.

What Are the Advantages of ISO 15378 Certification for Businesses?

Key benefits of ISO 15378 for businesses include:
✓ Improved safety and quality of medical packaging
✓ Stronger compliance with GMP and international regulations
✓ Reduced risks of product recalls or contamination
✓ Enhanced customer and patient trust
✓ International credibility and recognition
✓ Competitive advantage in healthcare markets

Advantages of ISO Certification

The benefits of ISO certification are extensive for businesses. First of all, it enhances customer trust, strengthens brand reputation, and provides a competitive advantage in international markets. Among the benefits of ISO certification are increased efficiency, improved processes, and reduced costs. It also facilitates compliance with legal regulations and fosters a culture of quality management, boosting employee motivation. Thanks to the benefits of ISO certification, companies not only increase customer satisfaction but also gain new business opportunities.

Certificate Features

✓ International Recognition
✓ QR Code & Online Verification
✓ Delivered in PDF Format
✓ Digitally Signed & Stamped
✓ Issued in English
✓ Shareable Verification Link

Application Process

✓ Add to cart. You can add multiple certifications before proceeding to checkout.
✓ Enter your company details.
✓ Select your company’s fields of activity.
✓ Proceed to the payment step.
✓ Complete your payment.
✓ Receive your certificate by email.
✓ Certification will be reviewed, approved, and delivered via email within 7 business days.
✓ If your application is not approved, a full refund will be issued. It comes with a 100% Money-Back Guarantee.

Key Considerations

✓ Certification is accredited and globally recognized.
✓ Each certificate includes a QR code and online verification link.
✓ The process is fully online, transparent, and efficient.
✓ Full refund guarantee if the certification is not approved.

Validity & Renewal

Your certificate will be valid for 1 year, in line with global ISO accreditation practices.
Annual renewal is available via our website.

Affordable Fee

We use digital evaluations rather than expensive on-site audits, delivering the same internationally accredited certification at a lower cost, without compromising on quality or global recognition.

100% Money-Back Guarantee

If your certification is not approved, we provide a full refund. The process is risk-free, transparent, and internationally valid.

Frequently Asked Questions (FAQ)

How long does the process take?
Certificates are issued within 7 business days of application.

How can certificates be verified?
Each certificate includes a QR code and verification link, accessible online worldwide.