The key principles of product responsibility for pharmaceuticals and diagnostic tests are specified in Orion’s Quality Manuals. All materials, manufacturing and quality control stages and distribution stages are 100 per cent traceable.

Traceability of products and operations

Orion maintains documentation systems which enable the traceability of all events, actions and results relating to the development, manufacture, quality or safety of medicines reliably and rapidly, independent of the means used for storing information.

Each medicinal product bears a code defining a single batch. By the help of the code, the correctness and propriety of the batch can be ensured. This traceability is of vital importance for finding out whether a mistake has occurred during the manufacture of a batch.

Also the diagnostic products are traceable by the help of the batch code all the way throughout the supply chain, from the materials to the finished product.

Product recalls

Medicinal products failing to comply with their specifications and which may cause harm to their users are recalled by Orion from the market. Depending of severity the case, medicines are withdrawn either from the wholesalers and retailers only or also from patients.

Orion has the systems in place to enable a prompt initiation of a recall procedure, and a prompt and accurate communication. The recall can be initiated also outside the business hours if necessary. The effectiveness of the recall procedures is tested regularly.

The criteria for product recall for diagnostic products are specified in the Quality Manual and the procedures in internal guidelines on customer complaints and hazardous situations caused to customers. The key guidelines are related to handling customer complaints, sales restrictions or recalling batches from the market. They also address country-specific guidelines, such as Warnings and Sales restrictions in Canada and Vigilance Reporting in the United States.

Go to indicator 'Product recalls and product defects'.