Thermo Scientific CONNECTS at GPSG Brazil Delivers Enterprise-Level Productivity Linking Laboratories to ERP

The Global Pharmaceutical Supply Group (GPSG) Brazil is an APILA unit of Janssen-Cilag Farmacêutica Ltda., (www.janssen-cilag.com. br) located in São Paulo, Brazil. Janssen-Cilag is one of the world’s leading research-based pharmaceutical companies specialising in pain management and fungal disease, and a member of the Johnson & Johnson family of companies, the world’s largest personal care and health products manufacturer. GPSG Brazil has adopted a comprehensive enterprise integration solution to streamline business processes. The adoption of Thermo Scientific CONNECTS at GPSG consists of laboratory instrumentation and informatics software, enterprise systems and document management tools to provide a fully integrated pharmaceutical manufacturing environment. Standardisation on Thermo Scientific LIMS and Atlas CDS has allowed GPSG to focus on product quality in its Brazil facility. Every month, GPSG Brazil’s manufacturing plant in São José dos Campos, São Paulo, processes more than 10,000 analyses to ensure the quality of nearly 2,000 samples of raw materials, packaging materials, semi-finished and finished products. The site is fully equipped with an incoming laboratory plus microbiological, chemical, analytical development and research and development laboratories. Business Challenge Pharmaceutical manufacturing companies such as GPSG Brazil are required to control the quality of their analyses according to specific US FDA guidelines, which apply to electronic format records that are created, modified, maintained, archived, retrieved or transmitted in their laboratories. These regulations are valid even for records that are not used in a submission, such as training records and SOPs. As a consequence, one of the major challenges facing GPSG Brazil was the need to use validated CDS and LIMS systems that enable compliance with standards and procedures enforced in this highly regulated environment. For GPSG Brazil, a coherent strategy that integrated data between the LIMS, CDS, ERP (enterprise resource planning), and Documentation system across the enterprise was a key business driver. GPSG Brazil selected Thermo Scientific LIMS to deploy in its laboratories to ensure integration with corporate enterprise resource planning package, SAP R/3. Between the production plant and the laboratory that analyses data from production, there is a need for regular exchange of information about quality and analysis values. By interfacing the LIMS with its ERP, GPSG Brazil can expedite the data flow between the lab and the manufacturing functions, streamline data handling, and integrate data collection and reports. Ronaldo Galvao, Quality Operations Director – GPSG Brazil clarified, “At the time we selected Thermo Fisher as our vendor of choice, we made the decision to standardise on a company with proven expertise in the pharmaceutical industry. We needed a validated product that provides us with sufficient flexibility to deliver all the requirements that a pharmaceutical plant has such as data security and consistent quality data; a centralised repository for the Quality Management data; fast and accurate data storage and recovery and all the industry functionality.” Post-implementation Benefits Seamless integration of laboratory instruments to the LIMS and the LIMS to the existing ERP system at GPSG Brazil ensures full regulatory compliance; for example, with the US FDA 21 CFR Part 11 standard that covers storage and integrity of computer systems data. Controlled and traceable versions of the original data are created and the whole history of any modification carried out is securely stored, thus ensuring complete system validation. The CDS/ LIMS integration also supports and enables the periodical auditing of the supplier certification system utilised by the company to guarantee the quality of its raw materials. Ronaldo Galvao explained, “The LIMS/CDS solution achieves quick and accurate transfer of high volumes of data, increasing sample throughput and improving laboratory productivity.” The integration of LIMS, CDS and ERP at GPSG Brazil has enabled their researchers to view information that was previously only available in data reports. “The overall integration of our connected informatics solutions provides a seamless and secure quality environment at GPSG Brazil,” concludes Galvao.