Patient safety

All drug use involves risk of side effects in various degrees and forms. In addition, drugs can interact with other substances—simultaneous use of other drugs or consuming food or drink can alter a medication’s effect. Pharmaceutical production, testing, and manufacturing must be extremely carefully regulated to achieve the highest possible patient safety. Patient safety is always a top priority for Meda.

Safe manufacturing

Confidence and trust in Meda as a supplier are crucial. Its Supply Chain function uses a continuous improvement process to achieve the highest quality and delivery reliability at Meda’s own manufacturing facilities, contract manufacturers, and other suppliers. Meda has its own production units in
Merignac (France), Cologne (Germany), and Decatur, Illinois (US). They are all subject to strict regulations and guidelines applicable to pharmaceutical
manufacturing for each of the territories where the products are sold.

Demands on suppliers

Meda’s strict policy is that primary products, materials, equipment, and other services that are purchased from approved suppliers must observe Meda’s requirements of safety, quality, price, functionality, and supplier ability to deliver on time. Meda has made good progress in its process of placing the same high demands on suppliers as it places on its own operations, when it comes to ethical and environmental issues. Supplier response is very good, since there is a significant competitive advantage in meeting these requirements. Meda does Good Manufacturing Practice (GMP) audits on all new contract manufacturers and implements annual follow-up audits. In certain instances, external consultants carry out audits on Meda’s behalf. GMP contains a strict set of regulations that are implemented within the pharmaceutical industry. These audits look principally at quality issues, although they also obtain an overall impression of the production facility in areas such as environmental, safety, and ethical factors. As part of Environmental Management System implementation per ISO 14001, Meda has formalized the requirement to account for environmental and ethical factors when auditing contract manufacturers.

Clinical trials

Meda’s development focuses on clinical studies in a late phase and registration work—meaning that each drug has already been tested several times on humans. In cases requiring clinical trials, Meda hires specialized contract research companies. These services are procured as per Meda’s policy for clinical trials, which has specific regulations for how the work can and must be executed. Examples of the guidelines included in Meda’s policy for clinical tests include those adopted by the EU for the 2001/20EC directive and Guidelines for Good Clinical Practice (GCP)—an ethical and scientific quality standard with origins in the World Medical Association Declaration of Helsinki.

Drug registration

Meda has local expertise in registration within all marketing companies. Principal tasks include managing registration of new and existing products and monitoring and developing products during their life cycle, as per prevailing legislation, guidelines, and public authorities’ requirements. Meda also cooperates with local registration and pharmaceutical authorities—particularly for production of user instructions and prescription information—to ensure that medications are used correctly and for the right purpose.

Pharmacovigilance

Meda aims for the safest possible use of medications and has its own pharmacovigilance department, which is continually active in Germany, Sweden, and the US. The task is to detect, assess, investigate, and prevent any adverse effects from the use of Meda’s pharmaceuticals. When required, changes may be made in basic information about the drug. Or, restrictions related to the drug’s use may be added. The department’s staff handles all side-effect management within Meda, which includes reporting possible side effects to each country’s pharmaceutical authorities.