Our work at Orion focuses on patients and their well-being. It is crucial to establish a safe and effective dosage for patients while minimising the adverse effects. Patients and doctors must also be able to trust that the product will act as intended in different patients.
Orion therefore works systematically to ensure the quality and efficacy of products at all stages of their life cycles.
Testing and production controls
Quality and efficacy are very important factors that are present already at the development stage of a product. Before pharmaceutical ingredients enter production, their safety and efficacy are tested in controlled laboratory conditions.
Before being tested on human volunteers, pharmaceutical ingredients are tested in test tubes and on animals. This provides important information about how the pharmaceutical ingredient will act in the body. Each phase has strict quality and safety criteria, which the ingredient must meet before progressing to the next phase. The efficacy and safety of a medicine are confirmed during the first studies involving humans.
The actual pharmaceutical production involves quality controls both during manufacturing and with the final pharmaceutical product. This is to verify that the pharmaceutical product fulfils all quality requirements and works exactly as intended.
Special attention is also paid to the packaging to ensure that the product retains its quality and efficacy all the way to the consumer and during its use. Pharmaceutical packaging serves as a safety barrier between the medicine and harmful factors, and its qualities play an important role in terms of shelf life. Correct and appropriate packaging protects the medicine and keeps it intact during its handling and delivery. The packaging must also protect the medicine against harmful light, oxygen, moisture and microbial exposure. For this reason, Orion’s pharmaceutical packaging undergoes strict testing processes.
Data are also collected afterwards
Pharmaceutical companies and the authorities continue to monitor the safety, efficacy and quality of pharmaceutical products after a medicine has been brought to market. Data are collected around the clock about suspected adverse events, insufficient efficacy, product faults, medication errors and interactions.
Information about adverse events and other factors affecting patient safety are updated throughout the life cycle of products. The monitoring of these is global, and is carried out by the national authorities in different countries in collaboration with pharmaceutical companies. Orion also has a designated department for the monitoring of safety.
Information about the efficacy and quality of products is also obtained directly from healthcare professionals. They provide information openly to Orion’s sales representatives, for example, about how various medicines have worked for their customers and whether they have any wishes concerning product portfolios. Their feedback is forwarded all the way to the product development department, where the product quality can be further improved based on the feedback.