Lonza continually strives to incorporate FDA, ICH, and other regulatory guidelines into the manufacturing processes for our custom media products. We were the first media manufacturer to achieve ISO 9001 Certification. Our manufacturing facilities undergo regular audits by the FDA in the US and the Belgian Health Ministry in Europe. In addition, we maintain Drug Master Files with the FDA for many of our media and buffers.
Lonza’s customers can save valuable time in the regulatory submission process by utilizing our records, documents, and quality standards as evidence of compliance with current regulatory requirements.
Manufacture of custom powdered and liquid media is compliant with 21 CFR 820, Quality System Regulation for Medical Devices following Current Good Manufacturing Practice (cGMP) Requirements.
Lonza documents all components, equipment, manufacturing processes, and test results for the finished product. Quality testing includes testing of incoming component and container-closure materials, and analytical and performance testing of the finished product. Raw material identity is confirmed by pharmacopoeial methods (USP/EP) including NIR.
An electronic batch record is used for the dispensing and formulation operations, providing real-time verification of raw material status and expiration date. Bar coding is used to identify dispensed components as well as raw materials. Full traceability from component material to finished product is maintained.
All finished products are provided with a Certificate of Analysis; other batch documentation such as a Certificate of Origin can be provided. Lonza Quality Assurance will work with you to meet your quality and regulatory compliance needs.
To schedule a site visit or audit, please contact us by phone at:
USA: + 1 888 403 8772
Europe: + 32 87 321 687