Product Safety and Quality

The LEO Pharma Quality Manual serves as a cornerstone document that defines the principles, policies, and standards governing our Quality Management System. It provides a clear framework for ensuring compliance with regulatory requirements and internal standards, while also fostering a culture of continuous improvement. The Quality Manual outlines the roles and responsibilities across the organization, ensuring alignment and accountability at all levels. It is a living document, regularly updated to reflect advancements in science, technology, and regulatory expectations, ensuring that LEO Pharma remains at the forefront of quality excellence.

Patient safety is our top priority and is addressed in our Code of Conduct. It outlines how everyone at LEO Pharma, working in any stage of a product’s lifecycle, is tasked with always following all relevant procedures associated with their role. All employees receive training on product safety and an annual refresher course on our quality policy and pharmacovigilance procedure, mandating all employees to report any safety concerns they are made aware of to the LEO Pharma Global Safety organization.

All employees working in GxP regulated areas receive annual GxP and Quality Manual training. Similarly, we conduct periodic competency reassessment and retraining at least annually or in case of absence exceeding 6 months, process changes or deviations.

We continually evaluate training effectiveness for specific topics, through periodic assessments and online training modules. In addition, we collect employee feedback for shopfloor training, to improve training content and delivery, and regularly review and update of training materials to reflect changes in regulations, policies, or processes.

At LEO Pharma, we are committed to ensuring the safety, quality, and efficacy of our products through rigorous and comprehensive testing and control processes, fully aligned with the stringent demands of the pharmaceutical industry. We strictly adhere to GxP (Good Practice) regulations, implementing robust quality controls at every stage of the product lifecycle. This includes incoming control of raw materials and components, in-process controls during manufacturing, and final release testing against predetermined quality specifications for both development and commercial products. These meticulous measures are designed to safeguard the safety and quality of our products before they reach patients.

The majority of product testing is conducted internally within LEO Pharma’s advanced laboratories, which are equipped with cutting-edge technology and staffed by highly skilled professionals. In specific cases, we also collaborate with carefully selected and accredited external laboratories to complement our internal capabilities. When external laboratories are engaged, we establish robust contractual quality agreements to ensure that all testing activities meet the same rigorous standards and comply with global regulatory requirements. By leveraging both our in-house expertise and, when necessary, the specialized capabilities of external partners, we ensure that every product meets or exceeds the stringent quality expectations of the pharmaceutical industry.

At LEO Pharma, we maintain robust Quality Agreements with our third-party suppliers involved in outsourced activities. These agreements ensure that all external activities comply with applicable GxP (Good Practice) regulations and meet the high standards required by LEO Pharma. To support this, we have implemented a comprehensive Supplier Quality Management procedure that governs the entire lifecycle of supplier relationships. This process includes supplier evaluation, selection, approval, ongoing monitoring of capability and performance, and, when necessary, termination. Each step in this process is proportionate to the risks associated with the supplied materials or services, ensuring compliance with regulatory requirements and safeguarding product quality.

Supplier audits are a cornerstone of our quality assurance efforts. We conduct audits for direct suppliers, component manufacturers, and raw material providers to verify compliance with regulatory standards and LEO Pharma’s internal requirements. The majority of these audits are carried out by LEO Pharma’s internal Global Quality audit function, with occasional support from independent third-party auditors. When third-party audits are utilized, they are conducted under LEO Pharma’s scope and instructions to ensure alignment with the regulatory quality requirements applicable to our products. The frequency of audits is determined through a risk-based selection process, with audits conducted prior to onboarding a supplier and at regular intervals thereafter to ensure ongoing compliance.

LEO Pharma requires all suppliers to adhere to relevant regulatory standards, which often include globally recognized certifications. Our supplier evaluation process ensures that suppliers have robust Quality Management Systems (QMS) in place, aligned with regulatory requirements and industry best practices for product safety and quality. Depending on the nature of the supplier’s services, this may include certified compliance with GCP, GDP, GMP, GLP, GVP1 , ISO 13485, EU Regulation 2017/745 (MDR), and FDA 21 CFR Parts 4, 11, 210, 211, and 820. Additionally, suppliers are required to train their personnel on product safety and quality, ensuring that their operations align with LEO Pharma’s commitment to excellence. This rigorous approach to supplier engagement reflects our dedication to maintaining the highest standards of quality and compliance throughout our supply chain.

At LEO Pharma, we are deeply committed to safeguarding patient safety and maintaining the highest standards of product quality through a robust and proactive approach to complaints and recalls. Customer complaints regarding the safety and quality of our investigational and medicinal products are continuously monitored, analyzed, and addressed to identify and mitigate potential issues before they escalate. This ongoing vigilance reflects our dedication to patient-centric care and regulatory excellence.

The handling of product safety and quality concerns is governed by stringent regulatory requirements and is formalized in LEO Pharma’s standard operating procedures. These procedures encompass all aspects of customer complaint management, adverse event reporting, and product recall processes. Employees involved in these critical activities receive specialized training to ensure they are equipped with the knowledge and skills necessary to manage concerns effectively. Additionally, the systems used to log and track complaints are validated to meet regulatory standards, ensuring accuracy, reliability, and compliance.

Regular monitoring and in-depth analysis of complaints enable us to proactively identify trends and implement corrective and preventive actions. In the very rare event of a product recall, LEO Pharma acts swiftly and transparently, adhering to regulatory guidelines to protect patient safety and maintain trust. This comprehensive and systematic approach underscores our commitment to delivering safe, high-quality products and reinforces our reputation as a trusted leader in the pharmaceutical industry.

If you wish to report a product complaint or report a side effect, please visit our contact page for direction to the proper channels.

Promotion of medicinal products is strictly regulated and monitored by local authorities. We are committed to upholding high standards and ensure compliance with applicable laws, regulations and ethical codes in all aspects of interacting with external stakeholders, including Healthcare Professionals, Healthcare Organizations as well as Patients, Patient Organizations, payers and other members of the public. This means maintaining processes and providing extensive training to ensure that promotional activities are appropriately evaluated and approved. All employees are trained in responsible conduct through our Code of Conduct, while employees involved in Sales and Marketing activities receive additional training in marketing, compliance assurance of material for external use, and HCP compliance.

Beyond regulatory obligations, we adhere to professional organization guidelines, such as the EFPIA Code of Practice to emphasize the importance of transparency and integrity. We maintain transparent and ethical relationships with all stakeholders to support patient care and access to therapies.