Sandoz is a leading player in the global generics industry. This, together with our intensive product filing activities, means we are frequently inspected. It is essential that we pass each and every test, to keep products on the market and to ensure business continuity.

With headquarters in Germany and major production sites in Europe, Canada, the US, Brazil, Argentina and India, Sandoz is committed to the pharmaceutical standards and requirements of bodies ranging from the European Union regulatory authorities through the US Food and Drug Administration (FDA) to the World Health Organization’s Good Manufacturing Practice (GMP) guidelines.

Sandoz also has its own quality system that ensures maintenance of the highest quality. Its pharmacovigilance system is aligned to the Novartis system and applies throughout the world. The executive management as well as the entire workforce implement its standards during their daily business activities. Our Clinical Safety Department monitors the safety profile of all our globally marketed products by providing medical quality reports to the health authorities on a periodic basis. A worldwide supplier qualification program assures the quality of the overall production process.

Three steps ensure global implementation of the high standards

• Internal requirements for all Sandoz production and quality units
• Local operational quality manuals ensure local implementation of Sandoz quality standards, while serving as a link to local working instructions
• Function-specific documents provide detailed descriptions of activities such as SOPs (Standard Operating Procedures), manufacturing and analytical procedures, working instructions

Our quality assurance (QA) concept guarantees that every product is inspected from the development phase to distribution by the respective quality assurance units. This applies to all products that are marketed, or are about to be marketed, by Sandoz organizations. A QA department at the company headquarters ensures continuous improvement and the timely implementation of new techniques and methods.

Sandoz is committed to optimizing the therapeutic use of established medicines. To this end, we have performed several clinical trials for major antibiotics in accordance with Good Clinical Practice (GCP) guidelines.

Our international Medical Department carried out clinical trials involving antibiotic therapies for a number of well-known conditions, including chronic bronchitis, tonsillitis and stomach ulcers. The results of these studies were published in leading medical journals or presented at international scientific meetings.

In Austria, for example, Sandoz was the first company to demonstrate – in two large multi-center studies - the effectiveness of a twice-daily administration of antibiotic amoxicillin. The result, which showed that a twice-daily dosage was just effective as the standard three doses per day, contributed significantly to ensuring that patients take medicines the way they are supposed to (patient compliance).