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.
The LIMS implementation was divided into cycles reflecting the production flow starting with raw materials through the packaging cycle, the semi-finished and finished products and stability. The CDS implementation was divided into four areas: solids, liquids, validation and residue analysis, because of the different types of inputs and reports specific to each one of these areas.
A seamless integration of laboratory instruments to the LIMS and the LIMS to the ERP system by GPSG Brazil supports full regulatory compliance. For example, the U.S. Food and Drug Administration’s 21 CFR Part 11 standard 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 assuring complete system validation. The CDS/ LIMS integration also supports and enables the periodical auditing of the supplier certification system utilized by the company to guarantee the quality of its raw materials. Galvao explains: “The LIMS/CDS solution achieves quick and accurate transfer of high volumes of data, increasing sample throughput and improving laboratory productivity.” In the case of failed data, the company can track both the original failed result and the actual chromatograph in the system. In this way, GPSG Brazil is able to find out if there was an operator error or a serious issue that would impact the quality of the product so as to take all of the appropriate actions to protect consumers. “Since the LIMS provides increased traceability, the system enables easy and quick access to background data associated with batches allowing for automated batch control,” adds Galvao.
The integrated system detects changes in the production line, determining new analyses to be made. Chromatograms can be viewed during the analysis, and the workbook can be customized in order to view the analytical results. All required modifications may be performed in advance, preventing unnecessary and time-consuming rework. The configuration of a list of user profiles enables controlled access to the system as well as to certain functions, efficiently protecting data. The use of this resource allows data to be available as a function of the user’s responsibility and his/her role in the laboratory. In addition, the system may incorporate a sequence and/or levels to allow access to the workbooks. The configuration of auditing actions for each user category makes it possible for researchers at GPSG Brazil to trace the modifications performed in the workbooks, record the names of the individuals who performed a given action, determine when it was performed and what was modified. Even if the network fails, data are safe since protection mechanisms ensure the workbooks’ integrity.
The implementation has enabled GPSG Brazil researchers to view information that was previously only available in data reports. As a result, delivery of results has been accelerated since fewer steps are required within the analysis process. Further fundamental functions are also offered such as the ability to withhold and return acquisition queues, full-screen chromatogram expansion and baseline editing defects correction. Additionally, the acquisition date is displayed on the chromatogram’s screen. This precludes an analysis sequence from being saved over another one, thus ensuring the integrity of the original data. “The overall integration of our connected informatics solutions provides a seamless and secure quality environment at GPSG Brazil,” says Galvao.
TO THE FUTURE, NOW
The LIMS is integrated with both the enterprise via the SAP system and the Janssen-Cilag proprietary documentation system. GPSG Brazil is also looking for enhanced integration of its chromatography data system, aligned with a company upgrade of Thermo Scientific Atlas CDS intending to link the CDS to SAP in addition to the existing integration with the LIMS. When the system migrates from the data servers to the 247 controller, GPSG Brazil will include the 3D spectral analysis module.
“In addition,” says Galvao, “the LIMS has the potential for integration with other business systems. With a longstanding LIMS in place, we are confident that we can meet any future challenges. And our CDS is flexible to deal with changes in our procedures and guidelines. If the data reliability is already high with our Atlas 2000 system, whose task is to collect process and ensure the safety of chromatographic data, then this reliability will be enhanced further with the new version.”
The connected integration solutions deployed in its multiple laboratories help GPSG Brazil to guarantee tight quality control throughout its business processes in compliance with strict regulatory controls — from material delivery, through production, packaging and distribution, to worldwide customer service. For GPSG Brazil, these systems are capable of storing data and methods in a safe and consistent way, thereby ensuring ultimate data security and integrity as well as effective processing distribution. As a consequence, the company is able to easily, timely and effectively access data in order to make better informed decisions in a faster and more reliable fashion. Galvao says, “With Thermo Scientific CONNECTS, GPSG Brazil is supported as processes change and business needs evolve.”