Regulatory Assistance

Global Compliance Standards

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.

Lonza Capsules & Health Ingredients’ 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, we provide a Certificate 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.

Products Standards

Only pharmaceutical and food grade gelatin is utilized in ® brand capsules, enabling our capsules to meet food and Pharmacopoeia standards
Lonza provides confidential detailed information about facilities, processes, articles used in manufacturing, processing, packaging, and storing of empty capsules through Type IV (Excipient) Drug Master Files submitted to the Food and Drug Administration in the U.S. and Type III (Excipient) Drug Master File submitted to Health Canada
We manufacture gelatin capsules from gelatin that complies with bovine spongiform encephalopathy (BSE) requirements
Capsugel® Vcaps® capsules, Vcaps® Plus capsules, DRcaps® and Plantcaps® capsules are made of plant origin, are Kosher and Halal certified, do not contain any GMO’s, and are approved by the Vegetarian Society
The safety of foods, dietary supplements and pharmaceutical products is a major concern for consumers, governments and the nutrition industry. As such we mitigate risks through a comprehensive quality control and assurance program not only making good business sense, it can actually lead to a reduction in costs for testing as well as savings in both fixed and variable costs.

Manufacturing Process Standards & ISO Information

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, Lonza, 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, we strongly suggest you seek your own expert regulatory advice.