EMBELIA , first European distributor to obtain ISO 15378 certification
ISO 15378 is the most exacting quality standard specifically intended for primary packaging suppliers to the pharmaceutical industry . EMBELIA , a major player in packaging , active in the design , development , distribution of complete primary packaging solutions : containers , closure accessories , decorations and associated services , is the first distributor in Europe to obtain this certification . Beyond the pharmaceutical industry , this level of know-how and requirement will benefit all EMBELIA ’ s customers whatever their sector of activity , cosmetics , beauty , wellness , food supplements , CBD , parapharmaceuticals , etc .
The aim of the ISO 15378 is to ensure patient safety . Certified companies must demonstrate their ability to consistently provide products and services that
58 FDPP - www . fdpp . co . uk 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 . It 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 explains : “ 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 , says : “ 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 .”
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