Pharmaceutical companies that seek to hire a contract manufacturing organization (CMO) must consider information technology (IT) concerns when they evaluate service providers. A sponsor company must investigate the manufacturing automation and systems, laboratory automation and systems, IT infrastructure, and business applications of each potential CMO. The authors describe the criteria that help pharmaceutical companies hire the appropriate CMO for their project.
Pharmaceutical and biotechnology companies use a web of contract research organizations (CROs), contract manufacturing organizations (CMOs), and other service providers to produce clinical-trial materials, provide process and formulation development, resolve problems in scale-up, and produce commercial quantities of drug substances and finished products. Pharmaceutical and biopharmaceutical companies may also seek contract organizations that can provide day-to-day operating services for internal functions that are not considered core competencies. When an organization outsources many of its key business processes to contract partners, it may be considered a virtual enterprise. Managing various contractors is difficult under any circumstances, but this task is particularly challenging in the highly regulated pharmaceutical industry. Effective project management, well-planned service-level agreements (SLAs), practical quality assurance, and effective use of information technology (IT) are key elements in managing a virtual enterprise, even when IT itself may be outsourced. Shortcomings in any of these areas can cause the delicate web of the outsourced supply chain to fail (see Figure 1).
A sponsor evaluates potential CMOs on the basis of their proposals, management experience, references, manufacturing capabilities, and record of compliance with good manufacturing practices (GMPs). The initial evaluation involves an assessment of a CMO's manufacturing facilities, processes, and supporting systems. A further assessment of the CMO candidates' quality and IT systems is crucial because these systems provide the sponsor with regulatory evidence, information and electronic reports, actionable data, and communications capabilities to monitor and manage the CMO. For example, the CMO's IT systems must be able to collect and report data on material-handling processes, laboratory results for active pharmaceutical ingredients, excipients, and finished products, as well as the manufacturing process controls (e.g., cleaning, sterilization, labeling, packaging) and the transport of the finished product.
Preselection IT assessment
A potential CMO might initially appear to meet the sponsor's superficial manufacturing requirements but closer assessment of the CMO's IT and control systems might reveal underlying risks. Figure 2 identifies key areas to assess regarding CMOs' manufacturing and laboratory automation and critical IT components.
Evaluating automated support and control systems as part of the due-diligence process in CMO selection is critical for identifying weak technology and business processes that will create risk for the sponsor. Depending on the size of the project to be outsourced, a preselection IT assessment of infrastructure, select systems and data, and communications capabilities should take between two to four days. A preselection IT assessment should include an evaluation of manufacturing automation and systems, laboratory automation and systems, the IT environment, and IT processes and controls.
Manufacturing automation and systems
The sponsor must evaluate whether the CMO's automated manufacturing-control systems are qualified. These systems may either control or collect data from manufacturing process equipment or packaging equipment. The sponsor should assess the CMO to determine whether the CMO has defined processes or procedures for the installation, qualification, and validation of manufacturing equipment, systems, and processes. If these processes and procedures are absent, then the CMO probably does not have evidence of a consistent controlled qualification of its manufacturing equipment or systems (see Figure 3).