Quality management

We manufacture in accordance with stringent international quality standards, so quality management is indispensable to our daily work. Every aspect of the supply chain is closely scrutinized – from the selection of raw material suppliers through to storage, manufacturing, handling, product release and shipment.

We work according to GMP (Good Manufacturing Practices) for medicinal products, international standards for food safety, such as HACCP (Hazard Analysis Critical Control Point) and US-CFR (Code of Federal Regulations), and ISO 13485 for medical devices. Our standards are regularly verified through audits by clients and international authorities.

On behalf of our pharmaceutical customers, we can prepare annual product quality reviews (PQRs), which are required by the regulatory authorities and customers. Ongoing process verification (OPV) spans the complete lifecycle of a product and we use the approach to continuously evaluate critical process parameters (CPPs) and critical quality attributes (CQAs). Thanks to OPV, the overall process capability is monitored and trends can be detected at an early stage, to enable corrective actions before the quality of a product suffers.

We strive for continuous improvement in order to maintain our quality standards at the highest level.

We have a dedicated team of in-house experts that regularly qualify and verify:

  • Manufacturing processes and equipment
  • IT systems and infrastructure
  • Analytical equipment, processes and methods
  • Production facilities
  • Warehouse conditions and logistics processes
  • Cleaning procedures
  • Personnel training
  • Suppliers through conducting regular audits

Our quality control approach encompasses every stage of the manufacturing process, from inspection of incoming materials and in-process control samples, through to product release and ongoing stability testing of finished products. We test all medicinal products, medical devices, food/dietary supplements and raw materials against their specifications according to national and international laws and regulations. We also analyze our primary and secondary packaging materials for quality and conformity with specifications, as well as all patient leaflets for completeness and readability.

Our cleaning validation and environmental and process monitoring (guaranteeing water quality, for example) not only ensure that regulatory requirements are met, but also that our production equipment and environment are suitable for the manufacture of high-quality products. In addition to implementing compendial methods, our quality control teams also strive to establish new analytical technologies to improve efficiency and lead times.