Our comprehensive Quality Governance Framework is designed to ensure transparency, accountability, and the proactive management of quality and product safety across all operations. It is supported by internal audit programs, customer audits and regular inspections by health authorities, with outcomes systematically reviewed and integrated into management oversight and the Quality Management System
Responsibilities for quality oversight are clearly defined at each organizational level, enabling effective reporting, escalation, and decision making across global, regional, and site functions. Quality performance data and emerging risks are systematically collected and reviewed through periodic quality review meetings, supporting timely management action and continuous improvement.
Lonza’s Chief Quality Officer (CQO) is a member of the Executive Committee and provides strategic leadership for Lonza’s global Quality Management System, ensuring consistent implementation and ongoing enhancement across the organization.
At site level, managerial accountability for product and service safety is exercised through Quality Review Committees, which are responsible for identifying and escalating critical quality related information to senior management. In parallel, cross functional Quality Committees at site and global levels oversee compliance activities, risk mitigation, and alignment with corporate quality standards, supporting a harmonized and risk based approach to quality governance across the Group.
Quality culture and training
Lonza is committed to fostering a strong, quality‑driven culture
supported by a comprehensive and structured training program for employees and
relevant contractors across its operations. The global training framework
includes role‑appropriate quality training, GMP education, and hands‑on
operational instruction for employees in manufacturing, quality, R&D, and
related functions.
Training is conducted during onboarding and refreshed on a regular
basis, including for senior management, to maintain alignment with quality
standards, product and service safety requirements, and evolving regulatory
expectations. Digital learning platforms provide continuous access to quality‑related
training content, complemented by external training partnerships where
appropriate.
Training completion and effectiveness are monitored through defined
documentation, internal controls, and audits, supporting consistent
implementation across sites and reinforcing accountability at all organizational
levels.
Lonza’s Process-Oriented Quality Management System (PQM) was designed
with standardized elements and processes. It was established by integrating
internal policies alongside national and international standards and
regulations. Our PQM is a management tool for:
- Describing and mastering essential business processes
- Assigning responsibilities for tasks and decisions
- Identifying key success factors and measuring performance
- Defining and managing key inputs and outputs
- Periodic auditing of the processes and assessment of the system
It is fully aligned with current Good Manufacturing Practices (cGMP), 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.
QRM is a foundational element of Lonza’s approach to product quality and
patient safety and is fully embedded within the Global Quality Management
System. It is applied throughout the entire product lifecycle, from development
and technology transfer through to commercial manufacturing and supply.
In line with global Good Manufacturing Practice (GMP) expectations,
Lonza employs a structured and risk‑based QRM framework to identify, assess,
control, communicate, and review risks that could impact product quality or
patient safety. Risk evaluations are grounded in scientific knowledge, process
understanding, and historical performance data, with patient protection serving
as the primary decision‑making principle.
Product quality and safety risks are systematically monitored using
defined performance indicators. Investigations use risk‑based root cause
analysis to ensure that underlying causes are identified and addressed.
Corrective and Preventive Actions (CAPAs) are defined and prioritized based on
QRM principles, and their effectiveness is routinely reviewed to confirm
sustainable risk mitigation.
Lonza maintains robust procedures for product disposition and recall
management, enabling timely and controlled decision‑making should potential
quality or safety concerns arise. These processes are designed to ensure that
risks are identified, escalated, and managed proactively, protecting patient
safety, regulatory compliance, and supply reliability.
Through the consistent and systematic application of Quality Risk
Management, Lonza aims to anticipate and mitigate potential risks early,
support reliable product supply, and maintain the confidence of
customers, regulators, and other stakeholders in an increasingly complex
operating environment.
Product and service targets
Lonza’s product and service targets are designed to support the reliable
delivery of safe, compliant, and high‑quality products and services to
customers across the pharmaceutical and biotechnology sectors. These targets
are underpinned by defined key performance indicators (KPIs), which are
regularly monitored to drive operational performance, customer satisfaction,
and continuous improvement.
Key product and service KPIs include on‑time delivery, quality
conformance, and the timely resolution of customer and quality‑related issues.
Performance against these indicators is reviewed through established management
processes to ensure that operational priorities remain aligned with customer
expectations, regulatory requirements, and Lonza’s quality standards.
Lonza is committed to ensuring that all products and intermediates
manufactured for or on behalf of its customers are safe for their intended use
and compliant with applicable regulatory and quality requirements. Product
development and manufacturing activities are conducted under stringent
regulatory oversight, in accordance with applicable GMP and, where relevant,
globally recognized quality management standards such as ISO 9001 or ISO 13485.
Products are evaluated throughout their lifecycle, from early
development through to commercial manufacturing, to ensure they are
manufactured and controlled in accordance with predefined specifications for
quality, safety, and efficacy. These measures are designed to support
compliance, mitigate health and safety risks for end users, and enable safe and
effective product utilization.
Lonza provides customers with comprehensive technical, quality, and
regulatory support to enable compliance with customer‑specific standards and
external regulatory obligations. While customers typically retain
responsibility for their own risk management frameworks and regulatory
strategies, we deliver the foundational data, documentation, and quality
oversight required to support safe and compliant product development and commercialization.
Through the consistent monitoring of product and service KPIs and the
application of robust quality and regulatory controls, we aim to deliver
reliable performance, strengthen customer confidence, and support long‑term,
sustainable partnerships.
Emergency response to ensure product and service safety
Emergency response procedures form an integral
part of Lonza’s management system and are designed to protect product quality,
service continuity, and patient safety under adverse conditions. These
procedures are regularly reviewed and tested through drills and scenario‑based
exercises to ensure continued preparedness across sites and functions.
Emergency simulations are used to verify
that defined roles and responsibilities, communication channels, and escalation
mechanisms function effectively under time‑critical conditions. These exercises
support coordinated and timely responses, enabling potential risks to
customers, patients, and operations to be identified and mitigated proactively.
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 and biotech markets. We work to achieve
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 handling 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, further
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).
Product quality
and safety performance metrics
Lonza monitors product and service safety
through its comprehensive Quality Management System, supported by clearly
defined performance metrics. These metrics enable the ongoing assessment of
quality conformance, operational execution, and the effective resolution of
quality‑related events.
Product safety performance is also
reflected in product recall monitoring. No product recalls were reported in 2025. Any potential quality issues are
managed in accordance with applicable regulatory requirements and internal
escalation procedures, enabling controlled decision‑making and regulatory
compliance.
Quality oversight is further reinforced through
regular internal and external audits and inspections. Audit and inspection
outcomes are systematically reviewed, and corrective actions are implemented
where required, supporting continuous readiness for regulatory oversight and
reinforcing consistent quality standards across the organization. In 2025, Lonza sites underwent more than 28
health authority inspections reflecting the growing complexity of our service
portfolio and the expansion of commercial development and manufacturing
activities. In parallel, the number of customer audits continues to rise,
helping to build our customers’ confidence in our capabilities and our shared
commitment to regulatory excellence.
