General
As holder of a manufacturing license, according to paragraph 13 of the AMG (German Drug Law), bela-pharm GmbH & Co. KG guarantees that the pharmaceutical products are so manufactured that their suitability for the foreseen use is guaranteed, that they meet the specified requirements and do not expose the patient to any danger due to uncertain or insufficient quality or effectiveness.
For this reason, bela-pharm GmbH & Co has implemented a quality assurance system (QA) which guarantees these aims.
The QA system of bela-pharm GmbH & Co supports the EC-GMP guidelines and is extended with further chapters which go beyond the EC-GMP guidelines, i.e. which are company specific.
Quality policy
Since its founding, the quality policy of bela-pharm has a special place in company policy. Due to its recognised importance, the company management is continually concerned with quality and quality assurance.
Due to the processing standards of veterinary drugs, there is a special responsibility towards the members of the medical profession, who prescribe the products and utilise the services, as well as towards the animals to be treated. The products must be of appropriate quality as laid out in the legal and company regulations. What is also needed to achieve this quality, alongside the manufacturing conditions and the quality control, is the understanding and co-operation of the concerned personnel. For this reason, a quality assurance system must allow for the active participation of the management and the personnel of the individual departments. Suppliers of basic materials and authorities are included in the quality policy.
It is a strict requirement of the management that only products which meet the requirements regarding quality and effectiveness are brought into use.
The regulations of the quality assurance handbook are binding for the personnel.
It is the duty of the heads of departments to make the handbook regulations understandable and to put them into practise.
The bela-pharm management has named someone responsible for QA and for the co-ordination of QA measures. His task specifically includes the management of all quality assurance activities as well as reports on the status of the QA system for the management. |
