Capsule Quality

Our quality and regulatory teams have the expertise and global experience to manufacturing finished dosage forms. With extensive expertise in the pharmaceutical and nutraceutical markets, our entire team focused on continuous improvement and regulatory compliance.

Many colleagues in our quality and regulatory departments are active members in global trade associations and stay ahead of evolving marketplace trends, new guidelines and emerging regulatory requirements. These memberships include participation in the International Alliance of Dietary/Food Supplement Association (IADSA), Food Supplement Europe (FSE), United Nations Population Fund (UNPA), Orthopaedic Trauma Association (OTA) and more.

As one of the world’s leading purchasers of raw materials for capsules, including gelatin and alternative polymers such as hypromellose (HPMC) and pullulan, we know that the quality of our finished dosage forms depends on the quality of these raw materials.

All the raw materials for our capsules are sourced from approved vendors under strict quality programs that include various stages from meeting purchasing specifications, successfully passing our supplier selection and qualification procedures, on-site auditing and ongoing performance monitoring.

By following these important principles of quality control, our customers can be assured that the raw materials, colorants and other ingredients used across our hard empty capsules meet the highest quality standards in the industry, with minimal risk of recalls or other sanctions.

Our international operations go beyond the minimum Good Manufacturing Practices (GMP) and quality system requirements. At every manufacturing site, we factor in the local regulatory or GMP requirements to ensure a standard for release and distribution at the local level. 

Each manufacturing site has successfully passed various inspections and adheres to the highest standards for safe products, including those for extended traceability, from incoming receipt to final shipment. We use hygienic equipment designed for product contact surfaces and employ food-grade and tamper-proof packaging. 

Due to our cleanliness measures and our stringent control over manufacturing operations, our capsules are manufactured to maintain a high microbiological quality level without the need for preservatives or sterilization using irradiation or ethylene oxide.

Our facilities are accredited with, among others, ISO 9001, FSSC 22000 and EXCiPACT certifications.

With an extensive compliance program focused on meeting the strictest international regulatory requirements for capsules and finished dosage forms, we work openly to maintain the trust of our customers as part of our transparent and collaborative approach. 

Although our empty capsules are designed to be globally acceptable, specific regulations applicable for the intended application in the anticipated target markets can be important when choosing the right capsule. We can help you in selecting the qualitative and quantitative composition in order to meet the regulatory requirements of your target markets.  

Upon ingredient selection and product formulation, we carefully consider applicable labeling legislation, providing Capsugel® composition sheets and technical information, to ensure that our customers have the necessary information for compliant finished product labeling.

Our quality release requirements are set taking into account physico-chemical and microbiological specifications that apply to the capsules’ end use in nutraceuticals and pharmaceutical excipients. Our validated test methods contribute to a comprehensive quality release process, allowing customers to be confident in the quality of the capsules they receive.

In addition, Lonza carefully selects and qualifies its transporters through documented quality requirements, making them aware of the product capsule type and required conditions. This final step is part of our commitment to conduct our business with the highest integrity and in compliance with all regulatory and legal standards.