Production & Quality Management

Team Production is responsible for manufacturing the products developed in R&D. Requirements for good manufacturing practices and product quality are defined, implemented and controlled by the Quality team in close collaboration with Production.


What does Team Production do?

  • Manufacturing of enzyme products
  • Transfer of manufacturing processes to external production partners
  • Procurement and storage of raw materials and consumables
  • Procurement and qualification of manufacturing equipment
  • Support of customer audits, authority audits and third party audits
  • Preparation of products for shipment

What does Team Quality do?

  • Management and continuous improvement of the company-wide QM system acc. to the certified standards ISO 9001 and Good Manufacturing / Distribution Practices (GMP/GDP) for pharmaceutical excipients
  • Quality assurance for all manufacturing processes (e.g. by evaluation of suitable raw materials and consumables, batch record review, etc.)
  • Management of deviations and changes during manufacturing and quality control in close collaboration with the departments
  • Quality control of internally and externally manufactured products acc. to specified analytical parameters and release of products before delivery to customers
  • Execution of product stability studies
  • Analytical method validation
  • Management of customer complaints

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