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Gary Walz is Senior Product Manager at Thermo Fisher Scientific.
A laboratory information system (LIMS) is a key tool in facilitating communication between a pharmaceutical company and its outsourcing partners; however, most LIMS require extensive customisation before they can be used in the pharmaceutical industry.
The pressure to contain costs is at an all time high for the pharma industry as the cost of raw materials continues to rise and more stringent regulatory requirements are mandated. In response, the industry is increasingly outsourcing manufacturing operations and raw materials development, which has led to a growth in the number of CMOs and API manufacturers. Just as pharma companies must comply with the FDA and other regulations, however, outsourced suppliers must also provide the same level of compliance throughout the entire process or production line. Furthermore, they must show their pharma sponsors the transparency necessary to obtain data quickly and easily.
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As the sponsor pharmaceutical company is ultimately responsible for the quality and safety of the developed drug, it will often dictate to CMOs and API manufacturers which methods and processes will be used. The sponsor will also usually deploy informatics software that facilitates information sharing and enables a reliable audit trail of data management to be traced through product development and manufacture. Enterprise level laboratory information management systems (LIMS) are increasingly relied upon as key contributors in this effort. Delivering advanced functionality that is specific to each stage of the drug development process, sophisticated and purposebuilt LIMS streamline processes, automate operations and reduce costs. The systems deliver real-time analysis and reports, facilitating regulatory compliance and product quality, and can integrate with a company's broader network to provide secure access to key data throughout the organisation.
Historically, industry standard LIMS have only delivered 30–40% of specific functionality targeted to each user's needs and have required extensive customisation to make them function in that particular setting.1 This minimal industryspecific functionality, combined with often outofdate proprietary languages or reliance on a costly IT infrastructure, has been particularly troublesome in the pharmaceutical industry, which has traditionally relied upon its own user documentation, design documentation, validation scripts and help files — all of which require continuous maintenance by an extensive IT staff. This high degree of customisation presents a drain on resources and increases the expense associated with maintaining laboratory infrastructure. As a consequence, implementing LIMS in various pharmaceutical laboratory settings has typically been a long, costly and arduous process — not only during installation and validation, but also in operating and maintaining the system over time.
The growing mandates of global regulatory compliance and longterm data traceability, as well as the complexity of laboratory testing and emphasis on batch versus sample management, have forced pharmaceutical manufacturers to extensively adapt generic LIMS to meet their specific requirements — lengthy and costly customisation, validation and implementation periods (in many cases lasting 36 months or more) have become routine.1
Because pharmaceutical companies rely on the external services of CMOs for production and API manufacturers for their raw materials, it is advantageous for informatics systems to be aligned between the sponsoring pharma company and their outsourced partners. This ensures that processes are consistent, manufacturing protocols are reliably maintained and that data are available throughout the entire chain of production to all levels of management in the sponsoring company.
Purpose-built LIMS that provide as much application-specific functionality as possible outofthebox eliminate the need for customisation and, ultimately, result in reduced validation and deployment time, as well as easier ongoing support. Such systems are already being implemented by many pharmaceutical companies because they provide the necessary documentation to meet regulatory and government standards, and can also help to generate cost savings in personnel and production time.
Purpose-built LIMS for pharmaceutical manufacturing processes have a unique batch and product-oriented design that aligns directly with the manufacturing workflow, allowing production data to be logically organised, summarised and reported. The system can also incorporate dashboardready functionality, enabling managers to make faster, more informed decisions. Further, if the system is built on Microsoft compatible interfaces, this can help facilitate end-user acceptance and support for the process modifications. A key component of any purposebuilt LIMS for pharmaceutical manufacturing should also be an environmental monitoring module that helps improve product quality monitoring and aid compliance by documenting important parts of the process and the environmental conditions involved. Additional standard functionality should also include dissolution and stability testing functionality, as well as product and batch management that provides laboratory managers with more control over their processes and more electronicallygenerated information for audit trail purposes.
The builtin functionalities as described above enable more real-time information sharing between the pharmaceutical sponsor and its external suppliers, and also enable faster and more streamlined decision making — with an effective LIMS in place at all points of manufacturing, pharma sponsors have the information they need at each critical point in the production chain. According to a recent industry report,1 LIMS customers are looking for more "outofthebox" functionality, and expect LIMS to deliver the associated time and cost savings this specific functionality will bring.
In an environment of extreme cost containment, integrated informatics solutions can contribute significantly to pharmaceutical manufacturing operations by increasing product quality, improving efficiencies and aiding compliance with regulations. Enterpriselevel, purposebuilt LIMS serve as a common gateway that other informatics solutions (such as electronic laboratory notebooks or document management systems, instrumentation, enterprise systems and enterprise communications tools) can integrate with to facilitate consistent and secure data sharing, which can be used to make better informed decisions. These systems also ensure ultimate data security and integrity, as well as effective processing distribution.
Enterprise-level integration is crucial in today's business climate, where near instantaneous response is required by pharmaceutical companies and their outsourcing partners. The integration of the pharmaceutical company with its external suppliers will facilitate better data correlation and collaboration, endtoend report generation and more secure data exchanges, with the ultimate goal being to provide management with a dashboard view of the key business metrics essential to running the business.
Gary Walz is Senior Product Manager at Thermo Fisher Scientific.
1. Strategic Analysis of US Laboratory Information Management Systems (LIMS) Markets (Frost & Sullivan, 2008).