Tower of stregth to secure our quality standards

Our staffs have a long lasting experience in the production and quality control of active pharmaceutical ingredients

A combination of internal and external courses secures the professional training of our employees and contributes to the adaption to the growing demands on national and international level

The periodic qualification of our production lines and equipment is secured by a qualification master plan

The analytical methods for the release of raw materials, intermediates and final products besides those for the determination of the effectivness of cleaning procedures are validated according to current guidelines

The manufacturing processes for the active pharmaceutical ingredients are validated according to current guidelines as well as in consideration of customer demands

Cleaning validations are performed for all our production lines and active pharmaceutical ingredients in order to prevent cross contaminations and to guarantee product safety

The stability of our active pharmaceutical ingredients is monitored in ongoing stability studies and specified afterwards

Our risk management system secures the constant high level quality of our products. All potential risks will be identified and afterwards analyzed. Critical control points and limits are set in order to minimize risks. Those limits are verified in a monitoring system. Thus a continuous verification of processes and products is performed

The raw materials used for the production of the active pharmaceutical ingredients are exclusively obtained from qualified suppliers. A combination of quality agreements, raw material testing and supplier audits confers the continuous quality of raw materials

The quality assurance department is instrumental in the performance and supervision of internal and external audits by suppliers and sub contractors

The compliance with the good documentation practice is one of our high priority goals. We document everything - even our mistakes

The development activities are performed according to the guidelines of the good development practice

All processes underlie a change control system which records, judges and approve planned and unscheduled changes

The material flow is strictly controlled over a step vice procedure starting with the selection of suppliers, supplier qualification over setting of material specifications, the receipt of goods, taking of samples, the performance of analytical tests and ending in the release of the materials

Our inspection equipment underlie a monitoring system