Laboratory automation and systems

Figure 4

Laboratory instrumentation is considered differently than manufacturing equipment because the automation portion of the laboratory instrument is normally embedded into the instrument by the vendor. Thus, the analytical instrument and its embedded computer controls are installed as a single unit. The CMO should have functional and design specifications for the automated laboratory instrumentation and records documenting the installation (IQ) of the automated analytical instrument. These records may include the instrumentation specifications or installation instructions provided by the vendor. In the case of automated laboratory instruments, parameters will often be set or configured according to the intended use of the instrument. The CMO should retain a record of these configuration settings.

Once these activities have been completed, the CMO should provide evidence that the integrated application and laboratory instrument have been tested together and shown to function correctly according to the given specifications. This is often referred to as OQ.

As with manufacturing systems, a final check should determine whether the CMO has documented procedures for the ongoing operation, maintenance, and change control for this automated laboratory instrumentation and associated systems. If the CMO has performed these activities and retained the specifications and records, the sponsor can be confident that the CMO's automated laboratory instruments are qualified and ready to execute the analytical methods that the sponsor requires. The sponsor will specify the analytical methods that must be performed by the CMO's QC laboratory. The CMO will be responsible for validating the analytical method on its automated instrumentation and within its laboratory environment.

If the CMO candidate cannot produce the documentation discussed above, the sponsor could be at risk for incorporating unacceptable materials into product, clearing unacceptable product for release, or maintaining inadequate specifications and records for regulatory purposes.

The CMO may also use various laboratory or quality systems that help execute the QC laboratory business processes but do not interact directly with automated instrumentation. These types of systems include laboratory information management systems, laboratory-chemicals inventory management, material-safety data sheets management, and deviation-reporting systems. These systems may be governed by select sections of 21 CFR 210 and 211, 21 CFR Part 58 (Good Laboratory Practice for Nonclinical Laboratory Studies), and 21 CFR Part 11 (Electronic Records; Electronic Signatures). The need for system validation depends on the system's intended use and the applicable regulations. If validation is required, the CMO should use a process similar to the one described in the manufacturing section. The sponsor should require the CMO to have similar documentation for this validation.