Laboratory automation and systems
The sponsor should determine whether the CMO candidate will provide quality control (QC) laboratory capabilities and operations.
In certain cases, the sponsor may decide to hire an independent QC laboratory contractor. If the CMO candidate is to provide
QC capabilities, the sponsor must determine whether the CMO's QC laboratory instruments and systems are qualified. These systems
may control or collect data from analytical laboratory instruments or help automate laboratory processes such as sample management.
The sponsor should assess the CMO to determine whether it has defined processes or procedures for the installation, qualification,
and validation of automated laboratory instrumentation, laboratory systems, and processes. If these processes and procedures
are absent, the CMO probably does not have evidence of a consistent, controlled qualification of its laboratory instrumentation,
analytical methods, or laboratory systems (see 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.
A laboratory-instrument application software package often provides the functional interface between the automated instrument
and the laboratory technician. At a minimum, functional requirements or specifications should document the functionality of
the application. The CMO should also have documented evidence that this application software, and any associated computer
hardware, has been installed according to the manufacturer's specification and the CMO QC laboratory configuration requirements
(IQ). The CMO should also verify that the application communicates correctly with the automated instrument.
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
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.