Abstract
In recent years, the use of automated sample handling instrumentation has come to the forefront of bioanalytical analysis in order to ensure greater assay consistency and throughput. Since robotic systems are becoming part of everyday analytical procedures, the need for consistent guidance across the pharmaceutical industry has become increasingly important. Pre-existing regulations do not go into sufficient detail in regard to how to handle the use of robotic systems for use with analytical methods, especially large molecule bioanalysis. As a result, Global Bioanalytical Consortium (GBC) Group L5 has put forth specific recommendations for the validation, qualification, and use of robotic systems as part of large molecule bioanalytical analyses in the present white paper. The guidelines presented can be followed to ensure that there is a consistent, transparent methodology that will ensure that robotic systems can be effectively used and documented in a regulated bioanalytical laboratory setting. This will allow for consistent use of robotic sample handling instrumentation as part of large molecule bioanalysis across the globe.
This is a preview of subscription content, log in via an institution to check access.
Author information
Authors and Affiliations
Corresponding author
Additional information
Guest Editors: Binodh DeSilva and Philip Timmerman
Key Terms
Audit trail: Record of events that occur during the use of a system that should include the time, date, user identification, what occurred, and the reason. This is also known as log files or trace files for some systems.
Automation: For the purposes of this paper, the term automation (and related terms such as “automated system” or “system”) refers to robotic liquid handling systems such as the Tecan or Hamilton systems linked to other necessary assay hardware components such as plate washers, shakers, etc. Data acquisition systems such as the Gyrolab or Bioplex do not fall under the scope of this paper.
Calibration: Periodic setting of instrument parameters that allow instrument to function as intended.
Change control: Documentation of any change to the system after the original installation. The change control documentation will require IQ and OQ to show that the change is working as expected, with the exception of a configuration only change control.
Configuration management: The process of generating documentation of the settings of the system for use and tracking any changes to the system settings throughout the lifetime of the system. This includes user roles, privileges, and groups as well as audit trail and electronic signature settings, if applicable.
Configuration only change control: Documents setting changes in the system software. Only OQ documentation is required in addition to the configuration only change control, as an installation is not performed.
Decommissioning: Removing a system from active use.
Full automation: Entire assay performed by one automated system with all assay steps performed by the system.
Installation qualification (IQ): The IQ is comprised of documentation that demonstrates that the system is installed properly. The extent of the IQ documentation depends on the type and complexity of the system installation. The IQ is performed for every instrument installation.
Interface: A connection that allows communication between the software/computer and the instrument.
Modular automation: A combination of steps in a procedure that can include automated steps from multiple automated systems, including data acquisition systems, but also manual steps. For example, a Tecan robotic sample handling system being used automatically with a separate plate washer and plate reader that are not part of the Tecan instrumentation would be a modular system.
Operational qualification (OQ): The OQ is comprised of documentation that demonstrates that the system is operational in its installed environment. The OQ is performed for every instrument installation.
Performance qualification (PQ): The PQ is comprised of documentation that demonstrates that the system performs the functions that the users need it to do and is performed only once per version of the software used. This is also referred to as software or system validation.
Remedial maintenance: Procedures performed on a system to correct an error or issue with that system.
Risk assessment: Procedure used to determine the criticality of an instrument, which in turn determines whether PQ is required.
Routine maintenance: Periodic procedures performed on a system to ensure that the system continues to perform as expected. This includes preventative maintenance (PM), verification, and calibration.
Script: The program used on the instrument to perform the needed functions. Can be a general script that is used for more than one assay (example: quality control preparation) or an Assay Script that is used as part of a specific analytical method for analysis.
Standard operating procedure (SOP): Document that describes use of the system and will include safety concerns. An SOP may also include decommission information.
Test incident log: Document that lists any unexpected events that occurred during the PQ and how they were resolved.
Test worksheet: Document that describes the purpose, procedure, and expected results of a PQ test.
Traceability matrix: Charts each user requirement with the test worksheets that test them.
User requirements: Document that defines what functions will be used and tested as part of PQ.
Validation: The process of evaluating a system, instrument, assay, or script to provide a high level of assurance that they will perform accurately and consistently in accordance with intended user expectations.
Validation plan: Document that describes the system and how the system will be tested.
Validation summary: Document that includes the test results and a statement that the system is ready for use.
Verification: Periodic checking of calibration parameters to demonstrate that the instrument is still functioning as needed.
Rights and permissions
About this article
Cite this article
Ahene, A., Calonder, C., Davis, S. et al. Automation Practices in Large Molecule Bioanalysis: Recommendations from Group L5 of the Global Bioanalytical Consortium. AAPS J 16, 164–171 (2014). https://doi.org/10.1208/s12248-013-9551-x
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1208/s12248-013-9551-x