LIMS in the spotlight

Electronic data management is a must for improving GMP Compliance and enhancing laboratory efficiency in the pharmaceutical industry is not an easy task

“Changes in the current environment, both economic and regulatory, make it imperative for pharmaceutical companies to invest in LIMS.”

AS THE pharmaceutical market grows increasingly competitive, the industry faces unique challenges including severe regulatory scrutiny and increasing financial pressure. In response to growing challenges to become more efficient, pharmaceutical companies are increasingly looking for flexible solutions to streamline all laboratory processes. In today’s economy managing data electronically is a key goal, enabling laboratories to perform more activities in the same amount of time, thereby increasing productivity and enhancing financial returns.

This article highlights the importance of Laboratory Information Management Solutions Systems (LIMS) at Wockhardt UK, a 16000m2 facility with MHRA and FDA approval for manufacture of sterile injectables, cartridges, specialised and standard dosage forms and specialisation in lyophilisation. Wockhardt is a contract manufacturing organisation (CMO), with a  (market capitalisation of $1.3 billion) with throughout  12 coordinated facilities in Europe, Asia and USA.

As business, IT and regulatory environments have evolved, so too have LIMS and their role in the pharmaceutical industry. The management of data is a key factor in the pharmaceutical industry as diverse laboratories, complex batch management and testing methods all demand sophisticated informatics solutions. 

LIMS are designed to automate and simplify existing processes as well as help laboratories increase efficiency and improve GMP compliance. The latest advances in LIMS are being applied by Wockhardt UK, who which has standardised on Thermo Scientific Nautilus LIMS to enhance its efficiency and improve GMP (Good Manufacturing Practice) compliance. The investment in advanced LIMS has enabled the company to increase productivity, throughput and accuracy while improving data administration, sample traceability and regulatory compliance.

Prior to implementing a LIMS, Wockhardt UK required a cost justification along with approval from the Company Board of Directors. Documentation and validation activities provided the company with the opportunity to minimize costs and to ensure the project was financially viable. Within the pharmaceutical manufacturing industry there is immense pressure to streamline and become more efficient across businesses, with clearly demonstrated cost justifications.

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 per cent 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 ($220000).

At Wockhardt UK, analytical trend data was being recorded and assessed manually, so there was a need for a LIMS that would readily generate trend data in an acceptable format to support all internal investigation and reporting functions. In 2003, Wockhardt UK identified that a LIMS would automate and simplify existing manual paper based processes. In addition, the company also required a system to improve the management of health and safety information for the department, so that safety data relevant to the testing could be accessed directly.

Intense regulatory scrutiny means an informatics solution must satisfy both internal and external auditors, including the flexibility to support widely varying review and approval workflows for static data (product specs, study protocols) and dynamic data (test results, batch disposition). 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. 

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 UK has had a significant impact on throughput. Since its introduction the number of materials and products requiring testing has grown by over 50% - 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 previously possible.

LIMS configurations and workflows were established for incorporating most of the company’s 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 flexibility and functionality provided by Nautilus LIMS.

One unique 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 1200 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.

The implementation of Nautilus LIMS at Wockhardt UK 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 due to improved sample turnaround, which has also had a positive financial impact by decreasing 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. The Nautilus upgrade continues to demonstrate the success of the LIMS implementation at Wockhardt UK, 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.

Changes in the current environment, both economic and regulatory, make it imperative for pharmaceutical companies to invest in LIMS. Efficient informatics solutions enable laboratories to operate more efficiently and thus more economically. Modern LIMS are designed for the unique requirements of dynamic laboratories, enabling pharmaceutical companies to increase productivity, throughput and accuracy while improving data administration, sample traceability and regulatory compliance. The pharmaceutical industry faces ever-increasing volumes of data produced by extended testing and more efficient instruments. As a result companies are looking for IT solutions that are easy and rapid to deploy and adopt, easy to upgrade and seamlessly integrate into their organisations’ existing enterprise systems.

The integration of informatics solutions in pharmaceutical manufacturing laboratories is particularly relevant in today’s pharmaceutical industry, where speed, accuracy and efficiency are critical. Nautilus is now fully managed in-house at Wockhardt UK 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. 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.