Goals and performance

As a pharmaceutical company, Orion must ensure that the drugs developed, manufactured and marketed by it are proven to be safe, effective in the indications they are approved for, meet the quality requirements set for them as well as the needs of the customers and patients. As a manufacturer of diagnostics products, Orion is responsible for ensuring that the tests work as planned and produce reliable results of the patient’s condition to support appropriate treatment decisions.

Orion maintains good readiness for required action in case significant adverse effects were identified or drugs or other products of improper quality were released for sales and distribution.

For these goals, Orion applies systems and procedures which allow the planning, implementation, monitoring and continuous improvement of appropriate operations.

Procedures

The key product responsibility principles for drugs and diagnostic tests are specified in the quality manuals approved by Orion’s management. Critical operations are furnished with guidelines to manage activities and ensure quality.

Orion purchases the materials, consumables and tools required in product manufacturing from qualified suppliers. Raw materials and packaging materials for pharmaceuticals are inspected before approval to production. Pharmaceuticals and diagnostic tests are manufactured according to good manufacturing procedures (GMP) and validated processes.

To ensure uncompromised product safety and quality, Orion inspects each manufactured batch to verify its quality before approval to sales. All materials, manufacturing and quality management phases as well as distribution phases are fully traceable.

For products contract-manufactured for Orion by a third party, Orion ensures the regulatory compliance and performance of the manufacturer as well as the appropriateness of the manufacturing facilities by relevant agreements and regular audits.

Orion systematically collects information about the adverse effects of the drugs it markets and continuously assesses their safety profiles and risk/benefit ratios. When required, appropriate action is taken based on this information to ensure safe use of the drug. Documents describing the properties of the drug to healthcare professionals and patients are updated as necessary and in cooperation with the authorities so that those taking or prescribing the drug have access to essential information required for safe use of the drug. In some cases, it may be necessary to withdraw a product from the market, for safety reasons.

Customer complaints of the drugs and diagnostics products are recorded for the basis of checking whether defective products have been released to the market despite the quality assurance procedures. This can be done reliably, thanks to the good traceability of materials and operations. When necessary, Orion recalls its preparations from the delivery chain and, depending on the severity of the defect, also from the consumers.

The product recall cases are carefully explored by Orion to identify the mechanism that caused the defect and to launch required corrective and preventive measures.

Organisational responsibilities

The authorisations and responsibilities as well as the management structure for product responsibility are specified and described in the quality manuals and more detailed instruction documents approved by Orion’s management.

The organisation which is responsible for the quality of the drugs and diagnostic tests must be independent so as to be qualified to make decisions.

Training and awareness

Thanks to their academic training and professional experience, the persons in charge are able to assess the situations and introduce solutions in the correct scale.

Other personnel have been instructed to escalate any adverse effect issues to the responsible organisation.

In addition to Orion’s personnel, the operators who provide Orion’s phone services have been trained to escalate any queries which call for urgent action and are made outside office hours to Orion’s experts.

Monitoring and follow-up

Manufacturing and sales of drugs requires certain regulatory permissions. During the authorisation procedure, the regulatory authorities have ensured that Orion has the appropriate qualities for the operations and that each drug released by Orion meets the specified requirements.

The pharmaceutical regulatory authorities (Fimea in Finland) and the regulatory authorities responsible for healthcare equipment and supplies (Valvira in Finland) monitor and assess Orion’s operations in regular inspections. These inspections also assess the effectiveness of the procedures in place for the follow-up and processing of adverse effects and complaints and the readiness to withdraw a product from the markets.

Numerous international business partners also assess Orion’s ability for regulatory and contractual compliance every year.

Orion monitors its operations with internal audits and management reviews and develops internal procedures systematically.

Counterfeit medicines pose an increasing global risk. Orion has not been affected by counterfeit products yet, but monitors the situation closely. By monitoring the situation, Orion maintains a readiness to react in case the legislation in this area changes.