ABX provides a range of different products with different quality levels from research grade through GMP grade of the starting materials for the radiopharmaceutical production up to finished radiopharmaceutical product (investigational medicinal product) in order to meet customers needs according to the developmental/clinical stage of their projects.
The strategy of ABX is to produce high quality products and continuously upgrade its quality management system. Quality assurance aims to obtain safe and reliable products of the required uniform quality. All processes from purchase of raw materials, incoming goods control trough production and quality control to release, storage and distribution are covered by our quality system.
The quality departments at ABX work closely with other departments such as manufacturing departments and sales. All quality related procedures are in compliance with the requirements for Good Manufacturing Practice (EU GMP), ICH guidelines and pharmacopoeia/compendial regulations, as applicable. The principles of the Quality Management are executed during the entire life-cycle of relevant products.
Quality Audits
ABX is successfully inspected by competent local authorities as well as by U.S. Food and Drug Administration (FDA). In addition, ABX is audited by customers on a regular basis.
The compliance with regulations has been verified by the issuance of GMP Certificates by the national authorities and of the Establishment Inspection Report (EIR) by FDA.
Some of the certificates granted to ABX include:
ABX performs regularly evaluation of its own suppliers to verify the compliance with European and global regulations and to prevent possible non-conformances.
Improvement of Quality Control Processes
ABX works pro-actively on a continuous improvement of quality in all departments. We conduct regular internal audits to monitor the results on a regular basis The goal is to maintain the highest level of quality of our products and compliance with regulations and standard practices in the pharmaceutical industry through preventive actions.
Complaints
ABX has established detailed procedures to manage complaints which covers the entire product portfolio and is not restricted to GMP grade product.
Each complaint received is investigated thoroughly by relevant departments. The complaining party is informed about the results of investigation.
Guarantee of Quality
ABX follows and implements all applicable legal regulations of the Federal Republic of Germany, international regulations, standards and as well as the requirements and provisions of all contracts with local and international partners.
Quality Policy
The following quality policy has been defined by top management:
All quality relevant working steps are conducted by qualified employees who are very well aware of the necessity of an appropriate quality and consequences of lack of quality.
This is ensured by a careful and accurate choice of employees together with regular trainings and qualifications.
Each employee in each level of the company takes responsibility for the quality of his/her work which is part of their job title.
Each manufacturing step and control step is designed to achieve reproducible quality and to be able to give unambiguous evidence that the required qualities are met.
Quality is not only a nature of the product. The quality of our products as well as our services provided for our customers is very important for us. Optimization of this quality is supported by top management in form of content and by providing the required resources (personnel and financial resources).
Compliance and fulfillment of legal and internal provision in the field of manufacturing of our products as well as in the field of safety and protection of human beings is continuously monitored through appropriate measures.
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