Quality

Report a Quality Concern

If you wish to report a suspected quality defect or any other product quality concern, please contact us:

Email: info@orelia-pharma.com
Phone: +31 (0) 6 2230 2083
Address: Industrieweg 1T, 4661 VN Halsteren, Netherlands

When submitting a report, please include the following information where available:

  • Product name and batch number
  • Description of the quality issue
  • Date of receipt or supply
  • Relevant photographs or supporting documentation, if available
  • Your contact details

All information will be treated confidentially and handled in accordance with applicable data protection legislation.

Regulatory and Quality Responsibilities

Mr. K.C.M. Aerts holds the following regulatory and quality roles within Orelia Pharma:

  • Responsible Person (RP) – Medicinal Products
    Officially listed in the Wholesale Distribution Authorisation (WDA).
  • Designated Person (AP) – Active Pharmaceutical Ingredients (APIs)
    Officially listed in the API registration.
  • Quality Assurance Manager (QA)
    Responsible for overseeing the implementation and maintenance of the Quality Management System (QMS) and ensuring compliance with applicable regulatory and quality standards.

Our Commitment to Quality

Orelia Pharma is committed to ensuring that the medicinal products we distribute are handled, stored, and supplied in accordance with applicable Good Distribution Practice (GDP) requirements. Maintaining product quality throughout the supply chain is a core element of our quality management system.

We take appropriate measures to preserve the identity, integrity, and quality of products during receipt, storage, transport, and distribution. Any suspected quality defect or other product-related concern is assessed, documented, and, where required, escalated to the relevant supplier, Marketing Authorisation Holder (MAH), or competent authority. Through these measures, Orelia Pharma supports the continued quality, integrity, and reliability of the medicinal products supplied within its distribution network.

Our Operational Commitment

Our commitment to quality is reflected in the following principles:

  • Distribution of products in compliance with applicable GDP requirements
  • Maintenance of appropriate storage and handling conditions throughout distribution
  • Timely investigation and escalation of suspected quality defects
  • Cooperation with suppliers, Marketing Authorisation Holders (MAHs), and competent authorities where required
  • Traceable, documented, and responsible handling of quality-related information

These principles ensure that patient safety and regulatory compliance remain at the forefront of all our activities.

Continual Improvement and the PDCA Cycle

Orelia Pharma is dedicated to the continual improvement of its Quality Management System. This commitment is supported by the PDCA (Plan–Do–Check–Act) cycle, a structured and systematic approach to enhancing processes and performance:

  • Plan: Establish quality objectives and processes in accordance with GDP requirements.
  • Do: Implement the planned processes and operational controls.
  • Check: Monitor and evaluate processes through audits, KPI's, and management reviews.
  • Act: Take actions to continually improve performance based on the evaluation results.

By applying the PDCA methodology, Orelia Pharma ensures that its quality system remains effective, compliant, and responsive to changing regulatory and operational needs.

Corrective and Preventive Actions (CAPA)

An essential component of our quality management system is the CAPA (Corrective and Preventive Action) process. CAPA ensures that deviations, complaints, or quality defects are not only addressed but also prevented from recurring.

  • Corrective Actions focus on eliminating the root cause of identified non-conformities.
  • Preventive Actions aim to identify and mitigate potential risks before they result in deviations.

Through systematic root cause analysis, documentation, and effectiveness checks, CAPA strengthens regulatory compliance and supports the reliability of the distribution network.

Kaizen – A Culture of Continuous Improvement

In addition to structured quality methodologies, Orelia Pharma embraces the philosophy of Kaizen, a Japanese concept meaning “change for the better.” Kaizen promotes a culture in which ongoing, incremental improvements are encouraged at all organizational levels.

This approach empowers personnel to identify opportunities for optimization in daily operations, enhances efficiency, and fosters a proactive quality mindset. By integrating Kaizen principles, Orelia Pharma strengthens operational excellence and reinforces its commitment to patient safety.

Conclusion

Through strict adherence to Good Distribution Practice (GDP), the application of PDCA, the implementation of robust CAPA processes, and the adoption of the Kaizen philosophy, Orelia Pharma ensures the highest standards of quality, integrity, and reliability. These combined efforts safeguard patient safety and support the responsible distribution of medicinal products across our network.