The guiding principles of the quality standards of Orion’s entire supply chain are based on full compliance with the EU-regulated good operating practices in manufacturing, laboratories, R&D and marketing, and efficiency and fluency of processes, product safety and consistent quality and high delivery reliability. Our operational practices are determined in quality manuals, internal guidelines and Standard Operating Procedure definitions. Especially detailed guidelines concern those operations and process phases, which are critical in view of the management and quality of our operations and the assurance of flawless products.
Managing product responsibility is an integral part of everything we do at Orion with which we ensure the uncompromised quality and safety of our products to their users. Compliance with regulatory requirements, guidelines, standard procedures to be followed, as well as our company codes and policies is required in both our own operations and those of our external partners.
Our own employees and our partners are required to show commitment to and understanding of our quality goals and their purpose: that the patient and the prescribing doctor can trust that Orion’s medicine is genuine and meets the specifications confirmed in the marketing authorisation, and that it has arrived into the pharmacy in a completely managed and controlled supply chain.
In sustainability, we are committed to high standards thus regard ourselves entitled to expect the same from our Third Parties. At Orion, our Third Parties include suppliers, distributors and other partners with which there is a transfer of value. Our Third Party Code of Conduct defines the minimum requirements to which Orion expect its partners to be committed. In addition to regulatory requirements, it includes key principles for business operations concerning sustainability and ethics. In addition, Orion expects its suppliers to acknowledge and adhere to Supplier Sustainability Requirements. These set a minimum set of requirements that Orion expect from its suppliers and ensure that our suppliers conform to our Third Party Code of Conduct and additional requirements for management systems, safe working practices, environmental, health and safety protection.
We select our sources of supply from global markets
Suppliers of materials and services to pharmaceutical manufacturers operate in global networks. Those numerous suppliers of goods and services, and subcontractors from whom we procure products and services are elementary contributors to our chain of operations, affecting its overall quality.
In supplier relations, we want to make sure that the quality and functionality of the supplier’s product or service, operations and supply process meet the standards set out in Orion’s Quality, EHS and other relevant Policies, regulatory requirements and Orion’s GxP requirements, Third Party Code of Conduct and Supplier Sustainability Requirements. The requirements and their priority order depends on the character, purpose and criticalness of the procured item.
As a main rule, we evaluate the eligibility of the supplier candidate based on questionnaires and on-site audits, for which we can use specialised service providers in addition to our own resources. The more comprehensive and critical sourcing is in question, the more important it is to us to conduct a detailed audit at the supplier candidate’s site to convince ourselves of their faultless quality.
The procedures we apply to the approval and follow-up depends on many factors, such as whether the procurement concerns a completely new product, service or supplier or an established relationship, as well as the criticalness of the product or service to Orion.
We classify our sources of supply using a variety of criteria. First, they are grouped into product and service categories. Classification as 'critical' or 'non-critical' is based on a risk assessment and the supplier’s importance in view of our product and procurement strategies. Having evaluated the supplier’s overall operational quality, we grant the supplier a qualification level, of which the highest is ‘Reliable, Audited’ the lowest being ‘Rejected’.
After the first evaluation, we keep our records up to date by systematically monitoring our suppliers’ ability to meet our requirements. Critical suppliers are re-evaluated annually, and all suppliers no later than three years from the previous evaluation.
In our procurement relations, we aim to establish long-term and constructive partnerships benefiting both parties. In regular meetings with the supplier, we agree upon development and activity plans and evaluate the fluency of the relationship. Dedicated persons and functions are appointed for the management of the most important partnerships.
For the basis of the collaboration, the obligations, responsibilities, terms and conditions and principles concerning the procured product or service are determined between the supplier and Orion.
