EMBELIA, first European distributor to obtain ISO 15378 certification

ISO 15378 is the most exacting quality standard for primary packaging suppliers to the pharmaceutical industry

EMBELIA, a subsidiary of the SGD PHARMA group is the first distributor in Europe to obtain the ISO 15378 certification. The group is a major player in packaging, active in the design, development, distribution of complete primary packaging solutions. Beyond the pharmaceutical industry, this level of know-how will benefit all EMBELIA’s customers whatever their sector of activity, whether they work with cosmetics, beauty, wellness, food supplements, CBD or parapharmaceuticals.

The aim of the ISO 15378 is to ensure patient safety. Certified companies must demonstrate their ability to consistently provide products and services that comply with customer requirements and applicable legal and regulatory requirements, by engaging in a continuous improvement process which aims for excellence.

Its scope covers the design, manufacture (GMP) and logistics of primary packaging items for medicinal products.

The standard includes criteria concerning manufacturing batches and their traceability, control of environmental conditions (cleanliness and hygiene), validation of critical processes and risk management.

The pharmaceutical industry expects their primary packaging suppliers to comply with this standard.

A long-term commitment to quality
Stéphane Hourdin, Quality Manager at EMBELIA, said, “The project was initiated in 2019 based on the quality system in place: ISO 9001. The additional requirements were gradually deployed to all our processes both in terms of infrastructure, traceability, organization, training and most of all using a risk-based approach.”

Stéphane VIgier, General Manager of EMBELIA, added, “The ISO 15378 standard is very exacting. This certification rewards the magnificent work done by our teams on a daily basis. It is a guarantee for all our customers beyond those of the pharmaceutical industry and for all our customers’ customers, be they patients or critical consumers. We bring them real and lasting security. The fact that we are the first in our field to obtain this certification is naturally a source of pride for the whole team.”