ISO 15378:2017 Primary Packaging Materials for Medical Products Certification – Guarantee Safety and Compliance

Who Can Apply for ISO 15378:2017 Certification?

This certification is intended for manufacturers, suppliers, and organizations involved in producing primary packaging materials for pharmaceuticals and medical devices. It applies to companies that manufacture glass, plastic, rubber, or aluminum packaging, as well as labeling and sealing solutions used to protect medical products.

What is ISO 15378:2017?

ISO 15378:2017 is the international standard that specifies requirements for a quality management system in the manufacturing of primary packaging materials for medicinal products. It incorporates Good Manufacturing Practices (GMP) principles, ensuring that packaging materials consistently meet safety, quality, and regulatory requirements. The standard helps prevent contamination, mix-ups, and defects, while ensuring product integrity throughout the supply chain.

When Was the Latest Version Released?

The most recent version of this standard was published in 2017. It aligns with ISO 9001:2015 requirements and integrates pharmaceutical industry-specific GMP principles.

Benefits of ISO 15378:2017 Certification

• Ensures compliance with pharmaceutical and healthcare regulations
• Guarantees the safety and integrity of packaging materials
• Minimizes risks of contamination and product defects
• Strengthens customer confidence and trust
• Improves operational efficiency through standardized processes
• Enhances competitiveness in the pharmaceutical supply chain

Who Is Eligible for ISO 15378 Certification?

• Manufacturers of glass, plastic, and rubber containers for medical products
• Producers of aluminum foils, blister packs, and seals
• Suppliers of sterile and non-sterile primary packaging
• Pharmaceutical and medical device packaging firms
• Organizations involved in pharmaceutical labeling and sealing solutions

How the ISO 15378 Certification Process Works

• Click the “Apply Now” button on this page
• Register your organization through our secure portal
• Submit required documentation about your packaging processes, GMP compliance, and quality management system
• Complete the payment process
• Certification will be reviewed, approved, and delivered by email within 7 business days

Remote Review and Digital Audit

The International Accreditation Board conducts a remote evaluation of submitted documents. On-site audits are not required. Certificates are issued after successful verification, with global validity.

Why You Should Get ISO 15378 Certified

• Demonstrates your compliance with GMP and ISO standards
• Strengthens your role as a reliable supplier in the healthcare industry
• Enhances patient safety by ensuring contamination-free packaging
• Reduces risks of recalls and regulatory penalties
• Expands international market opportunities

Key Considerations

• Certificates are internationally accredited and recognized
• Each certificate includes a QR code and online verification link
• The certification process is 100% online
• Full refund guarantee if certification is not approved

Business Advantages of ISO 15378 Certification

ISO 15378 helps organizations establish strong quality controls in the production of packaging materials for medicinal products, ensuring compliance with both ISO and GMP requirements. This certification strengthens your business reputation in highly regulated markets.

Validity & Renewal of Your ISO 15378 Certificate

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

Why Our ISO 15378 Certification Is More Affordable

We provide remote evaluations instead of costly on-site audits, offering the same internationally recognized certification at lower costs, while maintaining credibility and compliance.

100% Money-Back Guarantee

If your certification application is not approved, you will receive a full refund. Our process is risk-free, reliable, and globally valid.

Frequently Asked Questions (FAQ)

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

Is ISO 15378 mandatory?
While not mandatory, it is strongly recommended for packaging suppliers in the pharmaceutical and medical industries to ensure compliance and reliability.

Can small companies apply?
Yes, both small and large packaging manufacturers can apply for ISO 15378 certification.

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

ISO 15378:2017 Primary Packaging Materials for Medical Products Certification for Companies and Institutions