Lipoid Lipoid Lipoid Lipoid
 

Quality Policy

Lipoid Quality Policy Meeting the highest standards and requirements is the number one business goal of Lipoid. For that reason, all Lipoid manufacturing sites dedicated to the production of lecithins and phospholipids are cGMP certified (EU GMP Part II and ICH Q7 respectively).

Products that are offered for parenteral pharmaceutical applications are filtered, dried and packaged only in clean rooms (ISO 5 Norm).

In order to secure the ongoing and uninterrupted delivery of its products, Lipoid operates three independent production facilities.

Lipoid invests into production equipment upgrading on an ongoing basis to assure staying ahead of market demands and to set quality standards.
Drug Master Files (Type II and IV) and Common Technical Documents (CTD-Format) that meet the standards of the FDA (US Food and Drug Administration) or of the European Commission, respectively, are available for a number of products. Registration documents according to the requirements of other countries either already exist or are prepared on request.

Numerous products tailor-made for dietetic and food applications meet the strict criteria of the Kosher certification.

All Lipoid products are delivered together with a batch specific certificate of analysis. It covers the physical and chemical properties as well as the bacteriological status. Other purity criteria such as pyrogen or endotoxin tests are included in the certificates for products for parenteral applications.

The Lipoid quality management system is DIN EN ISO 9001:2008 certified.