Constant review of the quality
Quality Assurance is very important to us
From the input materials to the delivery, our medicinal products are constantly examined and controlled. Our efficient quality system lives through our highly qualified and continually trained employees.
Successful audits by international State Authorities and customers alike regularly confirm the consistent high quality that is achieved at our production site, safeguarded by the implemented quality assurance measures. You can rely on the quality of our active ingredients and medicinal products!
Our pancreatin is manufactured at our German site according to the current Good Manufacturing Practice /cGMP) guidelines.
The Quality Control Department monitors all manufacturing levels. Microbiological, biochemical and chemical-physical methods come into use to confirm the quality, with key elements being the purity and viral safety, as well as the enzymatic activities.
Analysis of Lipase
In our GMP Laboratory for Analysis of Natural Materials dissolution is tested for micro tablets, sugar-coated tablets and capsules to ensure that the goods have the required quality for further processing and release.
The determination of lipase activities (by titration) can take place at any manufacturing level, occurring from API (pancreatin powder or pellets) to lacquered and encapsulated microfilm tablets.
In addition to testing the API, the Laboratory for Microbiology, as part of the Quality Control Department, also examines finished medicinal products and input materials as well as intermediate products for total bacteria count and absence of indicator organisms according to the harmonized guidelines of the US-American and European pharmacopeia.