Standardization of Thermo Scientific Nautilus LIMS at Wockhardt UK Delivers Improved Laboratory Efficiencies and GMP Compliance
Profile
Wockhardt is a contract manufacturing organization (market capitalization $1.3 billion) and one of India’s top five research-based pharmaceutical companies. With more than 7,000 employees globally, Wockhardt supports a multidisciplinary research program involved in biotechnology, super-generics and new chemical entities. Key research areas include bio-generics, antibacterials and nutrition. Wockhardt is the first company outside of the USA and Europe to manufacture recombinant insulin and the launch of its hepatitis B vaccine was the most successful in Indian history.
Wockhardt operates 12 coordinated facilities in Europe, Asia and USA. Wockhardt UK, based on the Wrexham site of former CP Pharmaceuticals, is an FDA-approved manufacturing facility for sterile injectables. Wockhardt UK standardized on Thermo Scientific Nautilus LIMS to improve its efficiency and improve GMP compliance. Peter Sheppard is Wockhardt Quality Control Manager, based in the UK, and explains: “Our testing regimes are stringent. The integrity of products is what counts.”
Business Challenge
Wockhardt UK is a 16,000m2 facility with MHRA and FDA approval for manufacture of sterile injectables, cartridges, specialized and standard dosage forms and specialization in lyophilization.
The laboratory operation at the facility was manual, based on a paper system. Under Peter Sheppard, the team identified in 2003 that a LIMS (Laboratory Information Management System) would automate and simplify existing processes as well as help the laboratory improve efficiency and improve GMP (Good Manufacturing Practice) compliance.
An automated system was required to manage the issue and reconciliation of all laboratory worksheets. Analytical trend data was being recorded and assessed manually, so there was a need for a LIMS system that would readily generate trend data in an acceptable format to support all internal investigation and reporting functions. Wockhardt also wanted its system to improve the management of Health and Safety information for the department, so that safety data relevant to the testing underway could be accessed directly.
As a pharmaceutical company marketing products to Europe and the US, the LIMS deployed at Wockhardt UK would have to be validated and satisfy stringent European Medicines and Healthcare Products Regulatory Agency (MHRA), Good Automated Manufacturing Practice (GMP) and U.S. Food and Drug Administration (FDA) requirements.
New products have been a significant factor in the success of the Wockhardt UK business operation and a system was required that would be user-friendly and efficient, so that the department could respond quickly to changes and new product introductions.
Cost justification
In order to start the process of LIMS implementation, a cost justification was required along with approval from the Company Board of Directors. Utilizing Wockhardt personnel to perform the majority of the configurations, documentation and validation activities provided the company with the opportunity to minimize costs and to ensure the project was financially viable.
A number of areas where the LIMS would provide a degree of automation were identified. Over a three year period, the team estimated that the automation of laboratory worksheets and performing of calculations would save an average of five minutes per sample, while the automation of Certificates of Approval preparation and specification checking would save 10 minutes per sample. The team assumed a five percent increase in the number of samples received per annum and the anticipated volume increases equated with equivalent cumulative cost savings of more than £150,000 over a three year period ($220,000).
Vendor Selection
Initial discussions were held with three software suppliers to obtain a detailed understanding of how the LIMS would work and the benefits it could deliver. Thermo Scientific Nautilus LIMS was selected as the preferred option based on the ease of use, vendor support and references from other pharmaceutical companies.
A core project team of six Wockhardt personnel was formed and basic LIMS configurations and workflows were then established for incorporating most of the existing laboratory processes into the Nautilus application. The opportunity was also taken to simplify some of the existing working practices wherever possible, and build new processes, to take advantage of the fl exibility and functionality provided by Nautilus LIMS.
Peter said: “It was evident at an early stage in the implementation process that any LIMS application would have to be of benefit to the users themselves. If not, or if the users perceived it as an obstacle in their work, then the cost savings, and potentially the compliance improvements, would be lost.”
One feature of Nautilus LIMS enabled the construction of generic LIMS workflows for each of the different product lines: raw materials, steriles, tablets, non-sterile liquids, water testing and the viable environmental monitoring program. Each generic workflow would comprise all of the basic laboratory activities, from sample receipt to approval. Once established, a generic workflow could then be copied to create individual materials or products and the relevant specific details then substituted, such as sample quantities and specification limit.
There were approximately 1,200 product and material workflows, and 650 testing method workflows to complete at this stage. This was a major task and additional personnel from the laboratories were drafted in to work with the project team to facilitate this process.
Post-implementation Benefits
During an average month, the Wockhardt UK laboratory receives over 700 samples that require analytical testing. These samples comprise raw materials, components and tablets, as well as sterile and non-sterile liquids. In addition, the Microbiology section of the Quality Control (QC) department also supports a program of viable environmental monitoring, which requires the sampling, incubation and reading of over 6,000 agar plates every month.
The implementation of the Nautilus LIMS at Wockhardt has had a significant impact on throughput. Since its introduction the number of materials and products requiring testing has grown by over 50 percent – equivalent to 675 specification and method amendments every year. In order to monitor and quantify the improvements that the LIMS had achieved, users record the time spent on particular activities and performance data is derived directly from the LIMS for detailing testing turnaround times. Sample turnaround times have improved significantly and the ability to incorporate automated processes, such as the control and generation of laboratory worksheets, have also had a positive impact on departmental performance by freeing up analyst time. LIMS system administrators have been able to implement changes in the system, such as new materials and products, more rapidly than was possible previously.
The implementation of Nautilus LIMS at Wockhardt has also delivered financial benefits. A significant return on investment has been gained through Wockhardt’s ability to increase the testing capacity of the laboratories as the business has expanded without the need to increase headcount, which means throughput is boosted without adding further expenditure. Standard business lead times for QC testing have been reduced thanks to improved sample turnaround, which has also had a positive financial impact by reducing the company’s inventory holding.
In January 2008, Wockhardt’s in-house team completed a major software upgrade to Nautilus V8.1 to further enhance the functionality of the LIMS, data archiving and configurations processes – at the same time the team also took the opportunity to update its operating system from Windows 2000 to XP. The system re-validation was managed by the in-house team and Peter explains that experience with the earlier validation eased the process: “We used our prior experience to condense the number of critical parameters because the latest release of Nautilus included all of the existing functionality and many new features, and because we knew that Nautilus LIMS could deliver.” The Nautilus upgrade continues to demonstrate the success of the LIMS implementation at Wockhardt, with added functionality in a number of key areas including user interface, workflows, plate handling and data management. A new web-based data enterprise reporting solution features dashboard management that enables users to measure and even forecast key performance indicators in real time.
Nautilus is now fully managed in-house at Wockhardt by the same team which initially specified and implemented the system in 2003. Retaining the same project team throughout the development and validation stages has led to a much deeper understanding of the LIMS system and its functionality. This team continuity ensures a consistent approach to the development of the system and in the creation of documentation.
Future Plans
Wockhardt recently implemented SAP Enterprise Resource Planning (ERP) software across the entire enterprise in 2007. SAP’s QM-IDI (Quality Management Inspection Data Interface) is an open interface that allows data transfer between the QM application component of the ERP software and other systems, including Nautilus LIMS. The Wockhardt team is planning to integrate Nautilus LIMS into SAP via a direct interface. The planned integration will take place during 2010.
The project team also plans to fully integrate Nautilus LIMS with more than 50 laboratory instruments, which will represent a major project for the Wockhardt UK team for 2010.
Peter added: “From the outset, the system was owned and run by QC personnel. Additional support internally was available from the IT department, and externally from Thermo Fisher Scientific. However, the vast majority of the implementation was undertaken by the laboratory based project team. Involving other users from the QC department, listening to their needs and suggestions, implementing improvements, keeping everybody ‘on board’ at all times, have all added to the success of the project.”
About Thermo Scientific Nautilus LIMS
Count on Thermo Scientific Nautilus LIMS to increase productivity, throughput and accuracy while improving data administration, sample traceability and regulatory compliance. Nautilus LIMS offers ease of use for laboratory personnel without having to rely on IT for implementation and configuration of the LIMS to meet the laboratory’s work flow. For laboratories that require a dynamic data management system that’s flexible and configurable, Nautilus LIMS sets the standard with unparalleled levels of functionality and reduced Total Cost of Ownership.
In Good Company
Thermo Fisher Scientific is the worldwide leader in laboratory software and services, providing enterprise-wide, multi-laboratory solutions that are relied on at 19 of the top 20 pharmaceutical companies, and bioanalytical laboratories around the world, including PRA International Bioanalytical Laboratory (Netherlands), Nerviano MS (Italy), PharmaMar (Spain), Wuxi/Apptech (China), Covance, Advion BioServices, Inc. (USA), and many others. To support our installations, we provide implementation, validation, training, maintenance and support from the industry’s largest worldwide informatics services network.
For More Information
Visit us on the web at www.thermo.com/informatics or call +1 866 463 6522 (US) or +44 161 942 3000 (Intl).
