Quality
At Zentiva, quality is at the heart of everything we do.
Quality is the foundation of our business success and a guiding principle across all our operations.
We ensure the highest product standards through a robust Quality Management System (QMS) that supports full compliance with international and national regulations, including ICH guidelines. Every medicine we develop, manufacture, and distribute is made with a deep commitment to quality, safety, effectiveness, and regulatory compliance.
Zentiva’s commitment to quality is non-negotiable. Our strong track record of successful inspections by health authorities across our sites and affiliates reflects this dedication. We regularly host inspections from agencies such as the European Medicines Agency (EMA), MHRA (Medicines and Healthcare products Regulatory Agency), Swissmedic and the US FDA (U.S. Food and Drug Administration) and other national authorities to verify the quality of our development, manufacturing, and distribution practices.
To drive continuous improvement and maintain high standards, Zentiva runs a risk-based quality audit program covering internal operations and external partners. Quality Audits are conducted by qualified auditors and result in clear action plans that are tracked through to completion ensuring continuous improvement.
All our suppliers involved in GxP-relevant activities, including Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP), undergo a rigorous qualification and monitoring process. Responsibilities are clearly defined through contractual agreements, ensuring that all outsourced activities comply with regulatory and legislative requirements.
Through these measures, strong internal systems, quality audits, regulatory collaboration, and responsible sourcing, we uphold our Quality Policy and deliver on our purpose to provide health and wellbeing for all generations.
At the heart of our operations lies a robust Quality Management System (QMS), grounded in our Quality Policy and Quality Manual. These foundational documents define the principles and framework that guide all quality-related activities across our organization.
Our QMS is structured in alignment with the ICH Q10: Pharmaceutical Quality System, ensuring a comprehensive and proactive approach to quality throughout the product lifecycle. The Quality Manual outlines the structure and key processes of our QMS, which are consistently applied at every level of the organization to drive excellence and compliance.
We maintain a systematic and integrated approach to managing critical quality processes, including but not limited to:
Training and competency management
Deviation handling
Customer complaint management
Change control procedures
Risk assessment and mitigation
Corrective and preventive actions (CAPAs)
Third-party oversight and supplier quality
Internal and external quality audits
Our QMS is more than a compliance tool—it is the backbone of our Quality Operations, enabling us to deliver safe, effective, and high-quality products while meeting regulatory expectations.
Quality audits are a cornerstone of our Quality Management System (QMS) and a vital mechanism for continuous improvement, regulatory compliance, and operational excellence. Audits provide a structured, objective evaluation of our processes, systems, and practices.
They help us to ensure compliance with internal standards, regulatory requirements, and industry best practices, identify opportunities for improvement and innovation, strengthen accountability across all functions and levels of the organization, and foster a culture of transparency, integrity, and continuous learning.
Our audit program is comprehensive and risk-based, covering:
- Internal GxP audits: regular assessments of our own operations to verify adherence to our QMS requirements.
- External GxP audits: oversight of third-party suppliers, contract manufacturers, and service providers to ensure alignment with our quality expectations.
| Audits | 2023 | 2024 | H1 2025 |
| Internal GxP audits | 22 | 42 | 19 |
| External GxP audits | 268 | 269 | 151 |
| Total audits | 290 | 311 | 170 |
Our commitment to quality begins with a deep respect for regulatory expectations and a proactive approach to compliance.
We are committed to fostering open, honest, and collaborative communication during all regulatory inspections. Across all our sites and affiliates, we maintain a culture of transparency and mutual respect, ensuring inspectors receive timely, accurate, and complete information throughout the inspection process.
We take every inspection as an opportunity to strengthen our systems. Observations are addressed through timely, thorough, and well-documented Corrective and Preventive Action (CAPA) plans. These plans are developed collaboratively, implemented with priority and acknowledged by Health Authorities demonstrating our commitment to continuous improvement and regulatory excellence.
| Inspections | 2023 | 2024 | H1 2025 |
| European, Swissmedic, UK MHRA | 10 | 7 | 7 |
| US FDA | 0 | 0 | 1 |
| Other national authorities & ISO | 3 | 11 | 0 |
| Total regulatory inspections | 13 | 18 | 10 |
Our External Supply Operations are built on a foundation of strong quality oversight of Contract Manufacturing Organisations (CMOs). We uphold product quality through the following key practices:
- Supplier qualification: all CMOs undergo comprehensive due diligence including audits and technical assessments, to ensure they meet our stringent quality standards.
- Quality agreements: we establish clear roles and responsibilities through formal quality agreements, ensuring alignment and accountability across all partners.
- Performance monitoring: we conduct regular performance reviews using a Risk Ranking Tool, enabling proactive and data-driven quality oversight.