Whether you need to quickly respond to changing global demand or enter new and emerging markets to stay competitive, our insight into regulatory compliance can help you achieve your goals.
Capsugel products and manufacturing facilities conform to the highest worldwide quality and regulatory standards:
- Certificate of Analysis– As part of our commitment to world-class quality, Capsugel provides a Certificates of Analysis with every capsule order. This includes the specific details and test results of each lot of capsules, certifying the manufacture of these capsules is in accordance with established specifications. Many customers are able to significantly reduce incoming QA testing based on information supplied in the Certificate of Analysis.
- Regulatory Information on Colorants– We’re known for our extensive expertise in the global use and regulation of colorants. We only use colorants that comply with the current food and pharmaceutical legislation in the major regulatory regions (US, EU and Japan) where applicable. and as required by you, our customer. Our experts can, for each capsule product, verify its suitability for the intended application and geographical destination. They will meet with you throughout the development process to ensure compliance on a market-by-market basis.
- Capsugel capsules are manufactured under controlled climate conditions in accordance with applicable cGMP standards, using a dipping process on high-capacity automatic machines
- Printing of the pre-closed capsules, if desired by the customer, is undertaken before the capsules are transferred to final packaging
- Due to the high quality of its manufacturing conditions, Capsugel, does not use any preservatives, irradiation or ethylene oxide for preventing or eliminating microbial growth
- All Capsugel two-piece capsule manufacturing facilities have met the requirements for ISO (International Standards Organization) registration
As laws and regulations vary by country and their application is often fact-dependent, please contact us for detailed information related to the capsule manufacturing process used to produce our capsule products. And as always, Capsugel strongly suggests you seek your own expert regulatory advice.