We will support you in performing individual risk assessments and providing required documents and data like elemental impurities according to ICH Q3D, statements on residual solvents, BSE/TSE, GMO or allergens.
Also with respect to our excipient portfolio, Jungbunzlauer is constantly expanding its portfolio according to the customers and market’s needs. Please get in contact with us to get further information or to get a personal quote for one of our excipients.
Healthcare
Functions
Ingredients
Quality standards
The quality of our ingredients has a profound impact on the quality of your end products. Moreover, consistent high quality and purity of our products minimize the risk of quality deficiencies in your end products and thus minimise the risk of product liabilities as well as of brand and image damages. This is why we strive to the zero default principle – which applies not only to our products, it starts from manufacturing, packaging and logistics and includes the supply chain.
GMP
Jungbunzlauer’s APIs are manufactured at our production site in Ladenburg, Germany. This manufacturing site is compliant with current GMP requirements as set out in the guidelines by the FDA
and EU GMP Guide Part II. GMP certificates are available for all our APIs.
IPEC
The International Pharmaceutical Excipients Council Europe (IPEC) standards for excipients are practiced in our plants in Pernhofen, Austria and Ladenburg, Germany for our excipients.
GDP
According to EU guidelines, it is obligatory to transport medicinal products and APIs according to Good Distribution Practice (GDP) within the European Economic Area (EEA). EU GDP guidelines ensure high transport quality standards and integrity of medicinal products and APIs. At Jungbunzlauer, GDP guidelines are followed for all APIs as an integral part of our GMP system in the production plant in Ladenburg, Germany.
ISO9001
Fulfilment of the requirements of the ISO 9001 Quality Management Standards is the logical result of Jungbunzlauer’s comprehensive quality commitment and all company’s plants have been certified according to the ISO 9001 criteria. Furthermore, all Jungbunzlauer production sites have completed their Food Safety System Certification (FSSC) 22000. In this context HACCP – risk assessment concepts are established in our plants in Pernhofen, Austria and Ladenburg, Germany.
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