WuXi Biologics (Cayman) Inc. announced that it has received the License of Manufacturing Permit from German health authorities for its drug product facility (DP7) in Leverkusen, Germany. The permit successfully demonstrates for the first time that Premier Quality together with Record Speed WuXi Biologics consistently delivered in China can also be applied in global countries. The six-day inspection was conducted by five inspectors from the Health Authority of Cologne District Government (Bezirksregierung Köln) and other regional inspectorates. The scope of the inspections comprised not only the areas of cGMP manufacturing required for receiving the permit, but also commercial production approval. The inspection covered quality systems, documents and training, facilities, utilities and equipment qualifications, aseptic DP production, material and supplier management, QC Labs, as well as electronic systems and data
integrity. The facility is slated to begin commercial manufacturing of a key product next week.