The Group QM systems comply with the internal quality policy as well as with the international standards for Quality Management Systems as defined by the ISO 9001:2008. The systems are globally certified, where needed, by an independent institution.
Training is a central element of our QM system and is duly recorded in a validated EDP system (SAP). Details of training are described in SOPs.
As a manufacturer for the life science industry, Lonza is fully committed to the current Good Manufacturing Practices (cGMP) comprising the internal GMP policy as well as local law and international guidelines adopted by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA).
Lonza recognizes and acknowledges its responsibility for food and feed safety. During the manufacture of active ingredients for use in food and feed products, our company places the highest priority on the safety and health of our products, as regulated in our Food and Feed Safety Policy.
Quality Policy | PDF
Food and Feed Safety Policy | PDF
Summary of the GMP-Policy
Good Manufacturing Practice (GMP) is a set of regulations and guidelines that provide guidance concerning the manufacturing, holding and distribution of active pharmaceutical ingredients (APIs), chemical intermediates to produce APIs, medicinal (drug) products, food and food/feed additives.
These products must be manufactured under a controlled system for managing quality to ensure they meet appropriate specifications and are consistently produced in accordance with quality standards appropriate for their intended use.
This GMP Policy applies to the manufacture of APIs intended for human or veterinary use, API intermediate materials, including materials/products used in clinical trials, dietary supplements, vitamins, food and other feed/food additives required to be compliant with GMP, using the following production methods:
- Chemical synthesis
- Cell culture/fermentation
- Recovery from natural sources
GMP Policy | PDF