DATA MANAGEMENT: GLOBAL PHARMA SOLUTIONS
documentation system. Ronaldo Galvao, quality operations director at GPSG Brazil, comments: ‘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 fl ow between the lab and the manufacturing functions, streamline data handling and integrate data collection and reports.’
The laboratories at the manufacturing plant of Global Pharmaceutical Supply Group (GPSG) Brazil in São Paulo (Image courtesy of GPSG Brazil and Thermo Fisher Scientifi c)
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‘It’s one global ELN project, but with two technology platforms that are set up to communicate with each other,’ he says.
Manufacturing processes
GlaxoSmithKline’s manufacturing group also wanted to retire some of its LIMS servers housed at each of its eight or 10 manufacturing locations and implement a centralised data management architecture. The LIFT (Laboratory Information for Tomorrow) project looked to put in place a centralised architecture with LabVantage’s Sapphire LIMS as the central platform installed at GSK house in the UK. In order to aggregate the data and
harmonise it in a common format, GSK employed Waters’ NuGenesis SDMS. The SDMS parses the data and uploads it into LIMS, which ultimately produces certifi cates of analysis that are sent back to the manufacturing site to release the product. The LIFT architecture means it is virtually impossible to have a transcription error, because it’s all carried out automatically. ‘GSK wanted to avoid risk in the manufacturing process and one of ways of doing this is to reduce transcription errors through automating the process,’ comments Murphy, of Waters. Manufacturing is a highly regulated environment and one of the major challenges facing the São Paulo manufacturing plant
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of Global Pharmaceutical Supply Group (GPSG), in Brazil, was ensuring compliance with standards. GPSG Brazil is part of Janssen- Cilag Farrmacêutica and a member of the Johnson and Johnson family of companies. It processes more than 10,000 analyses per month to ensure the quality of nearly 2,000 samples of raw materials, packaging materials, semi-fi nished and fi nished products.
‘If we’ve spent money developing a product or technique and it’s buried in somebody’s lab notebook, then it isn’t fulfi lling its value to the company’
The company installed Thermo Fisher Scientifi c’s Atlas chromatography data system (CDS), validated to meet standards imposed by regulatory bodies. The CDS is integrated with 17 high-performance liquid chromatography (HPLC) instruments in the chemical laboratory, enabling all the chromatographic data to be accessed via one central server. The CDS solution was implemented alongside Thermo Scientifi c’s LIMS, which is integrated both with a corporate enterprise resource planning (ERP) package, SAP R/3, and with a Janssen-Cilag proprietary
SCIENTIFIC COMPUTING WORLD JUNE/JULY 2010
Cultural changes
According to Meek, of Thermo Fisher Scientifi c, one of the biggest changes for pharma companies is their dependence on external organisations. ‘The burden 15 years ago was to ensure the fl ow of information within the company and with external groups, but the majority of the work was done internally,’ she says. ‘Today, research organisations are also confronted with the additional challenge that much of that information originates at other facilities that are outside of their control, whether it is a contract research organisation, the clinic, or with an academic partner. It is not uncommon for companies to have 20-plus partnerships within a single therapeutic area.’ The key is connecting all of the organisations involved, and Thermo Scientifi c’s Connects product provides a framework for information sharing and collaboration. The importance of electronic records for
pharma organisations lies in preserving a company’s knowledge base. One comment from the contact interviewed from the US biotech company was: ‘If we’ve spent money developing a product or technique and it’s buried in somebody’s lab notebook, then it isn’t fulfi lling its value to the company.’ And these systems need to be connected
and integrated within a more centralised informatics architecture so that departments or sites are not operating in isolation. Web technology has facilitated these centralised architectures, as has the speed of the wide area networks (WAN). ‘Historically, the challenge of managing huge amounts of data from multiple sources in a centralised way really wasn’t possible,’ says Murphy, of Waters. ‘Now, having a single database that everyone can access is a powerful solution compared to the situation fi ve years ago, in which bandwidth and the software applications available limited large pharma companies’ ability to set up centralised software architecture.’
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