We are committed to providing customers with high-quality, safe and effective products and services that not only meet but exceed their expectations. To achieve these goals, we operate quality management systems that are compliant with current regulatory requirements and applicable standards. We strive to continuously improve our quality management system, products and services.
Quality Management System
The Lonza Process-Oriented Quality Management System (PQM) was designed with standardized elements and processes. It is established by integrating internal policies alongside national and international standards and regulations.
Our PQM is a management tool for:
- Description and mastering of essential business processes
- Assignment of responsibilities for tasks and decisions
- Identification of key success factors and measurement of performance
- Definition and management of important inputs and outputs
- Periodic auditing of the processes and assessment of the system
As a manufacturer for the life-science industry, Lonza’s quality management system is fully in alignment with the current Good Manufacturing Practices (cGMP), as well as local laws and international guidelines adopted by regulatory bodies such as the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), among others.
Quality and GMP Policies
We have a corporate quality policy that comprises the core of our beliefs regarding our quality management system and its strategic approach. Additionally, we have specialized quality-related policies tailored to address specific topics as necessary, like GMP.
Certifications
We are committed to provide customers with products and services meeting all specifications and fulfilling customer needs and expectations. The highest priority is given on the integrity of our products, ensuring their safe manufacture, distribution and compliance with environmental and other relevant regulations.
To achieve these goals, we operate quality management systems that adhere to internal policies, alongside national and international standards (e.g. ISO) and regulations (e.g. GMP and HACCP). The fundamental elements of these systems are continuously undergoing improvement.
Product Compliance
We are predominantly involved in business-to-business transactions. This constitutes part of our role as a supplier of goods that are used to manufacture final products for the pharma, biotech and nutrition markets. We work to ensure that our customers can safely use our products for their intended purpose. Generally, our customers also have their own procedures and specialists to assess risks, and we aim to provide the foundation and necessary data to support the safe use of their products.
For our products, health and safety profiles are evaluated through systematic processes and procedures that are embedded in our organizational and business structure. We have experts in regulatory compliance and registration, dangerous goods and product classifications, toxicology, risk assessment and product stewardship covering the regions and markets in which we operate. Potential hazards and risks associated with the intended use of our products are clearly communicated to customers via product labels, safety data sheets (SDS) and technical communications
Relevant programs for the handing of chemicals include the European Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) initiative, the US EPA Toxic Substances Control Act (TSCA) and California Safe Drinking Water and Toxic Enforcement Act (Proposition 65). In addition, other countries are launching similar regulatory schemes (e.g., China-REACH, Korea K-REACH and K-BPR, Turkey KKDIK and UK-REACH). These are ongoing efforts, and we strive to comply with requirements, including those related to REACH Substances of Very High Concern (SVHC). In addition, we use the Globally Harmonized System (GHS).