Excelling in Quality Management to Create Value
We at Lonza recognize that the very nature of our offerings – from life-saving medicines to nutritional supplements, from hospital and home disinfectants to biocides that prevent the growth of harmful mold on painted surfaces – requires that we must reliably provide our customers with products and services that not only satisfy their own demanding expectations, but also meet strict regulatory quality requirements. That’s why our advanced manufacturing, operational excellence, quality-control and quality-assurance systems are some of Lonza’s core competitive advantages. Lonza’s quality management priorities are the following:
- Delivering high-quality, safe and effective products and services that meet or exceed customer expectations
- Complying with current regulatory requirements and applicable standards
- Continuously improving our quality management system, products and services
To achieve these goals, Lonza operates a quality management system that complies with internal policies, as well as with national and international standards (e.g. ISO) and regulations – e.g. current good manufacturing practices (cGMP), Pharmaceutical Inspection Convention (PIC) and Hazard Analysis Critical Control Point (HACCP). The fundamental elements of the quality management system are continuously undergoing improvement.
Implementing a Global Quality Organization
In 2018 Lonza implemented a new global Quality organization covering all aspects of quality control and quality assurance. Having such a centralized Quality organization is fundamental to assuring a consistent approach to quality for the entire company. In a next step, we are also enhancing our quality management system in a way that core processes are standardized at the Corporate level and are applicable for all sites and businesses. This process started in 2018 and will continue in the coming years.
In parallel to the standardization of processes, we are further optimizing our training approach through harmonization of training curricula throughout the entire company, as well as through the systematic implementation of tailored qualification modules. Newly hired employees will get structured trainings focused on the specific tasks they have to perform at a certain point of time. Through a modular, stepwise approach, new hires are operational much more quickly while ensuring they are at all times properly qualified for all tasks they are asked to perform. Flawless execution and strong customer focus remain high priorities for Lonza. We strive to perfectly understand the expectations of our customers and act accordingly.
Launched in 2014 Lonza’s Error Prevention System and other operational excellence initiatives have helped us reduce the number of deviations while production output increased. These continuous improvement efforts, which extensively engage shop-floor employees in the quest for superior quality, also have had a positive impact on the batch success rate.
Being Constantly Audited by Regulators and Customers
In 2018 Lonza Pharma & Biotech sites underwent 37 regulatory cGMP inspections, which represents the highest number ever in Lonza’s history (2017: 26 inspections). In parallel, the number of customer audits is also increasing in line with the increasing number of commercial and developmental products in Lonza’s Pharma and Biotech business. Lonza strives for continuous improvements.
For example, we implemented corrective measures after the U.S. Food and Drug Administration (FDA) issued a warning letter in April 2017 regarding quality issues involving the production of certain biotherapeutic liquid media products at one area of our Bioscience Solutions site in Walkersville, MD (USA). The FDA completed a follow-up inspection of the site in July 2018 to verify that needed remedial steps were undertaken at that production unit, which resumed delivering products to customers in January 2018.
To be well prepared for future audits and inspections, Lonza is carefully monitoring the quality and regulatory trends in the industry in an ongoing manner and triggering proactive initiatives if needed. Lonza’s internal quality audit program verifies that any such actions are consistently implemented at the relevant sites. Those internal audits are also a great opportunity to identify and share best practices throughout the network, including the newly acquired sites.
Thanks to our proactive quality initiatives, Lonza is sustaining a reputation as a high-quality, reliable supplier throughout the Healthcare Continuum®.