Quality Assurance

General:

As the owners of a manufacturing permit acc. §13 AMG (German Medicines Act), Bela-Pharm GmbH & Co. KG ensures that the suitability of the pharmaceuticals produced is guaranteed for the intended use, that they accord with specified requirements within the scope of the certifications and that they cannot represent a hazard to patients by raising concern or through insufficient quality or efficacy.

The Bela-Pharm GmbH & Co. KG has implemented a Quality Management System based on legal pharmaceutical stipulations in order to maintain fulfilment of the requirements. The essential features and basic requirements of the QM System are defined in the Quality Management Manual, and defined by the company Management. Detailed descriptions can be found in the internal standard working and procedural instructions, in manufacturing and test protocols as well as in a multitude of other circulation documents.

Quality policy:

Since the company's foundation, the quality policy has been an important focus within the company policy. Due to the recognised importance of this topic, the Management consistently pay great attention to Quality and Quality Assurance.

Due to the production program - veterinary medicines - we bear a particular responsibility towards the members of the health-care professions and the animals to be treated who are given the products. These products must be of an appropriate quality and display the required efficacy across their entire declared lifetime without raising concern.

In order to fulfil these requirements, the understanding and involvement of our employees is of major importance in addition to manufacturing conditions and inspection facilities. For this reason, the Quality Management System provides for the active participation of the Management and the personnel from the individual divisions. Suppliers of raw materials and authorities are also incorporated into the quality policy.

The specifications laid down in the Quality Management Manual are mandatory for the entire staff of bela-pharm GmbH & Co. KG. The Heads of Division are responsible for implementing and making understandable the specifications in the manual.

The Management of Bela-Pharm has designated a Quality Assurance Representative who is responsible for the coordination of the QM measures. Their tasks include in particular the control of all quality-relevant aspects, the further development of the QM System and the reports to the Management.