Tekni-Plex has been a supplier to the pharmaceutical industry for almost 40 years. Our DMF 1348, is one of the oldest active Drug Master Files with the FDA for the supply of packaging materials to the pharmaceutical industry. From Tekni-Plex Europe, we mainly supply the following products for pharmaceutical applications:
Tekni-Plex has a strong focus to assure the production environment and quality systems comply with the GMPs. Critical packaging components for pharmaceutical use are produced in production environments which are built to the same clean room standards as for Pharmaceutical companies. Our plants comply with the ISO 9001 : 2015 quality standard and EN ISO 15378 : 2015 where applicable, and moreover we host multiple audits from our pharmaceutical customers every month.
We are well informed with respect to the regulatory requirements for primary packaging components, as well as the information that needs to be supplied by the pharmaceutical companies to the various regulating authorities in the world. It is our goal to maintain an up-to-date state of readiness so that all certificates can be supplied upon simple request, which will assure sufficient details can be submitted in the regulatory filings allowing a smooth approval of the packing sections. Tekni-Plex continuously monitors and updates the latest versions of the FDA and EMEA guidelines, Pharmacopoeia’s, Food Contact regulations and other relevant CFR or EU Directives.