We’re thrilled to announce that Yantai Wisepac Desiccant Co., Ltd., a proud member of the Wisesorbent Group, has officially obtained the ISO 15378:2017 certification, awarded by SGS, a world-leading inspection, verification, testing, and certification organization.

This landmark achievement reflects Wisepac’s ongoing commitment to excellence, with its quality management system for pharmaceutical-grade silica gel desiccants now formally aligned with international GMP standards.

Why ISO 15378:2017 Matters

ISO 15378:2017 is a specialized standard for primary packaging materials used in medicinal products, built upon the foundation of ISO 9001 but enhanced with GMP requirements tailored for pharmaceutical contexts.

While a standard ISO 9001 system focuses on consistent quality and general process control, ISO 15378 introduces additional controls that are critical to pharmaceutical packaging:

  • Clean environment and contamination control

    Clean environment and contamination control

  • Risk assessment, validation of critical processes

    Risk assessment, validation of critical processes

  • Traceability and material batch control

    Traceability and material batch control

  • Strict environmental condition monitoring (humidity, temperature, etc.)

    Strict environmental condition monitoring (humidity, temperature, etc.)

For a desiccant company supplying or intending to supply pharmaceutical or high-end packaging supply chains, having ISO 15378:2017 certification signals that the company is equipped to meet the demanding safety, reproducibility, and regulatory compliance expectations of customers and oversight agencies.

Looking Ahead

This milestone represents not only a significant achievement for Yantai Wisepac but also a foundation for deeper trust and stronger partnerships worldwide.

Moving forward, Wisesorbent will continue to benchmark against international standards, drive innovation, and deliver high-performance, reliable moisture-control solutions for the pharmaceutical, healthcare, and high-value packaging industries.

Email Us