Specializing in pain management and fungal disease, Janssen-Cilag Farmacêutica Ltda., is a research-based pharmaceutical company located in São Paulo, Brazil. Janssen-Cilag is a member of the Johnson & Johnson family of companies — the world’s largest personal care and health products manufacturer with worldwide annual sales totaling $63.7 billion. In an effort to streamline business processes, Janssen-Cilag’s Global Pharmaceutical Supply Group (GPSG) Brazil recently adopted a comprehensive enterprise integration solution. As part of its quest for a state-of-the-art IT implementation, GPSG Brazil took advantage of the latest technological advancements from Thermo Scientific in its São José dos Campos laboratory complex in São Paulo.
Pharmaceutical manufacturing companies are required to control the quality of their analyses according to specific U.S. 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 the APILA unit, 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 wanted to deploy state-of-the-art technology that delivered significant flexibility to meet the specific needs of the pharmaceutical industry, including stability, supplier certification and microbiological analysis. The company has been using a Thermo Scientific LIMS solution since 1999 to store and control laboratory quality data; and CDS solution since 2001 to collect, process and ensure safety of the chromatographic data generated within its laboratories.
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. Given the high sample throughput and high degree of reliability that any pharmaceutical company requires, proven systems and equipment help ensure maximum productivity and competitive advantage. To accomplish integration with its SAP R/3 corporate enterprise resource planning package, GPSG Brazil specified a Thermo Scientific LIMS to deploy in its laboratories to leverage the full benefits of a modern ERP solution. 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 explains, “At the time we selected Thermo Fisher as our vendor of choice, we made the decision to standardize 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 centralized repository for the Quality Management data, fast and accurate data storage and recovery, and all the industry functionality.”
The LIMS delivered immediate improvements to the laboratory, says Galvao, “When we originally implemented the LIMS it was a culture change. The LIMS allowed automated control of testing. It optimized the procedures including the skip lot functionality which determines the frequency of microbiological testing. The stability functionality generated metrics both for performance and for productivity.”
The Thermo Scientific CDS was necessary because GPSG needed a validated system that controls quality of the analysis in line with Johnson & Johnson guidelines. “The main reason that we looked for a CDS,” notes Galvao, “is for compliance with 21 CRF part 11 regulations. We need to use a validated system that demonstrates conformance with internal guidelines that ‘applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth in agency regulations.’ Using a CDS we can track and keep records, even if not used in submissions, such as training records and SOPs.”
The LIMS has been implemented in all of the São José dos Campos laboratories, including incoming laboratory, microbiology, R&D, Analytical Development and the chemical laboratory and is now used by about 118 Janssen-Cilag employees. The CDS solution used by 37 employees integrates 17 HPLC instruments in the chemical laboratory, enabling all the chromatographic data in the lab to be accessed via one central server. Thermo Scientific’s Atlas offers GPSG Brazil a high degree of security and data integrity and is capable of storing the data archives and methods database for the workstations, plus it takes care of the GLP requirements. Atlas allows security accesses to be managed in line with 21 CFR part 11; the approvals and rejections function follows the rules for electronic signatures, and the raw data integrity is taken care of. The application also contains modules for traceability and auditing that are used for management accesses. The combined implementation of the two systems generated considerably high data reliability, which led the company to upgrade to the latest versions of the systems and ensure their tight integration.