EMBELIA, first European distributor to obtain ISO 15378 certification ISO 15378 is the most exacting quality
comply with customer requirements
additional requirements were gradually
standard specifically intended for
and applicable legal and regulatory
deployed to all our processes both in
primary packaging suppliers to the
requirements, by engaging in a
terms of infrastructure, traceability,
pharmaceutical industry. EMBELIA, a
continuous improvement process which
organization, training, and most of all using a risk-based approach.”
major player in packaging, active in the
aims for excellence. Its scope covers the
design, development, distribution of
design, manufacture (GMP) and logistics
complete primary packaging solutions:
of primary packaging items for medicinal
Stéphane Vigier, General Manager
containers, closure accessories,
products. It includes criteria concerning
of EMBELIA, says: “The ISO 15378
decorations and associated services,
manufacturing batches and their
standard is very exacting. This
is the first distributor in Europe to
traceability, control of environmental
certification rewards the magnificent
obtain this certification. Beyond the
conditions (cleanliness and hygiene),
work done by our teams on a daily basis.
pharmaceutical industry, this level of
validation of critical processes and
It is a guarantee for all our customers
know-how and requirement will benefit
risk management. The pharmaceutical
beyond those of the pharmaceutical
all EMBELIA’s customers whatever their
industry expects their primary packaging
industry and for all our customers’
sector of activity, cosmetics, beauty,
suppliers to comply with this standard.
customers, be they patients or critical
wellness, food supplements, CBD, parapharmaceuticals, etc.
A LONG-TERM COMMITMENT TO QUALITY
The aim of the ISO 15378 is to ensure
Stéphane Hourdin, Quality Manager
patient safety. Certified companies must
at EMBELIA explains: “The project
demonstrate their ability to consistently
was initiated in 2019 based on the
provide products and services that
quality system in place: ISO 9001. The
58 FDPP - www.fdpp.co.uk
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.” www.embelia.com
