Thermo Fisher Scientific has announced that Global Pharmaceutical Supply Group (GPSG Brazil), a unit of Janssen-Cilag, which is a pharmaceutical division of Johnson and Johnson, has implemented an integrated informatics solution consisting of a laboratory information management system (LIMS) and a chromatography data system (CDS). The company will use the system to enhance the quality control in its São José dos Campos pharmaceutical production facility in São Paulo (BR). (More details of the application).Janssen-Cilag selected the Thermo Scientific CONNECTS solution, consisting of LIMS and CDS, to integrate its many instruments and laboratories. GPSG Brazil now uses the informatics solution in its five laboratories (Incoming; Microbiology; Chemical Lab; Analytical Development and Research & Development), and the solution has been integrated with SAP R3, GPSG’s enterprise resource planning system and the enterprise documentation system.
Every month, GPSG Brazil’s manufacturing plant in São José dos Campos, processes more than 10,000 analyses to ensure the quality of nearly 2000 samples of raw materials, packaging materials, semi-finished and finished products, in addition to water and stability testing. The site is fully equipped with an incoming laboratory plus microbiological, chemical, analytical development and research and development laboratories. The manufacturing plant handles both solids and liquids, including Tylenol 750 mg tablets, Tylex tablets, Nizoral tablets, Tylenol drops, Nizoral cream and shampoo and imported products such as Eprex and Risperdal tablets. In addition to holding a strategic position in the production of solids, liquids, creams and shampoos, GPSG Brazil imports a wide range of products while exporting to many Latin America countries including Argentina, Uruguay, Paraguay, Chile, Peru and Bolivia.
Given the high sample throughput and the high degree of reliability that is required of a pharmaceutical company, proven systems and equipment are vital to ensure maximum productivity and retain a competitive advantage. GPSG Brazil selected Thermo Scientific LIMS to deploy in its laboratories to ensure integration with the corporate enterprise resource planning package SAP R/3. For GPSG Brazil, the incorporation of product quality information from the laboratory within ERP systems was a clear priority. Between the production plant and the laboratory that analyzes data from production, there is a need for regular exchange of information about quality and analysis values. In order to leverage the full benefits of modern ERP solutions, GPSG Brazil needed a solution to interface the LIMS with SAP so that the LIMS feeds data into the ERP. 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.
This integration of a Thermo Scientific LIMS solution with various laboratory instruments, as well as quality management and enterprise systems, is a vivid example of Thermo Scientific CONNECTS in action. Thermo Scientific CONNECTS bridges the gaps between laboratory generated data and the enterprise level information that is required for mission critical management decisions by providing both the integration of instruments and systems and interoperability necessary to transform data into relevant business drivers for companies across the broadest spectrum of industries.
Thermo Scientific CONNECTS is a set of offerings that leverage the company’s breadth of LIMS and CDS capabilities, as well as expertise in enterprise systems integration to help streamline and improve the transfer of knowledge between laboratory-generated data and enterprise-level information systems. CONNECTS assists organizations in integrating application-specific workflows, thereby transforming laboratory data into relevant business information and maximizing a company’s enterprise system investments to better support critical management decisions in today’s resource-constrained environment.
According to Ronaldo Galvao, quality operations director, GPSG Brazil: “At the time we selected Thermo Fisher as our vendor of choice, we made the decision to consolidate with a company that has proven expertise in the pharmaceutical industry. We needed a validated product that provides us with sufficient flexibility to deliver all the requirements of a pharmaceutical plant such as data security and consistent quality data, a centralized repository for the Quality Management data, fast and accurate data storage and recovery, and all the industry functionality. The overall integration of our connected informatics solutions provides a seamless and secure quality environment at GPSG Brazil.”
Dave Champagne, vice president and general manager, Informatics at Thermo Fisher Scientific added: “Thermo Fisher Scientific works with many of the world’s leading pharmaceutical companies to support their manufacturing quality and ensure their ongoing success. We are very happy that Janssen-Cilag in Brazil depends upon our Thermo Scientific CONNECTS integrated solutions to ensure the continued quality of its output. Our growing presence in South America providing informatics solutions to a broad range of industries is strengthened by our work with GPSG-Brazil to support their ongoing production schedules and to improve their processes.”
No comments:
Post a Comment