APP Pharmaceuticals (formerly known as Abraxis Pharmaceutical Products) chooses Thermo Scientific Darwin Lims for a three site multi-phase rollout
Darwin, a purpose-built laboratory information management system (Lims) for pharmaceutical manufacturing R+D and QA/QC, will be deployed in all three of APP's manufacturing facilities located in New York, Illinois, and Puerto Rico.
APP Pharmaceuticals's products have helped millions of people in the United States and Canada fight critical illnesses by providing a broad portfolio of multi-source and branded injectable pharmaceutical products, including difficult to manufacture and urgently needed medical products.
The project is intended to harmonise processes, automate operations and consolidate data management in a single Lims across all three sites.
The multi-phase project will initially involve the deployment of Darwin's inherent environmental monitoring functionality enabling facilities to move from manual systems onto an automated system for microbiological samples from the sterile manufacturing environment.
The second phase of the project will feature an integrated Lims and chromatography data system (CDS) implementation followed by the third phase of the Lims rollout including SAP interfaces across all sites.
Hector Jimenez, senior director of quality operations at APP, commented: "We selected Darwin because it offers purpose-built functionality for pharmaceutical manufacturing - the solution is extremely easy to configure and use for our environmental and our chemistry laboratories.
"In addition, we are confident that Darwin Lims will provide efficiency improvements in the tracking of samples and in capabilities of trending data as well as compliance".
Darwin is a purpose-built Lims for pharmaceutical manufacturing R+D and QA/QC laboratories.
Since it contains an environmental monitoring module as standard, implementation and validation time and costs are greatly reduced versus generic LIMS.
Environmental monitoring is essential for product monitoring and compliance.
Thermo Scientific Atlas CDS is a GLP and 21 CFR Part 11 compliant enterprise CDS.
Atlas CDS provides comprehensive multiple vendor instrument control.
With ease of deployment and validation across laboratories and sites, laboratory efficiency is gained by automating the laboratory.
