Quality Management Systems
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Lonza is committed to provide customers with products and services meeting all specifications and fulfilling customers' needs and expectations. The highest priority and emphasis is placed on the integrity of our products, their safe manufacture and distribution and the compliance with all relevant regulations.
To achieve these goals, the Lonza operates local quality management systems, with common elements and processes, which comply with internal policies as well as with national and international standards (e.g. ISO) and regulations (e.g. GMP, PIC, HACCP). The fundamental elements of these systems are continuously undergoing improvement.
The process -oriented quality systems (PQM) of Lonza are management instruments which define the structure, organization, responsibilities and methods for implementation of the company's processes in compliance with the Group policies. |
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) |
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