Role of Quality Assurance in Clinical Flow Cytometry Assay Development & Validation

Good Laboratory Practice (GLP) is a set of guiding principals intended to ensure the quality and integrity of data for non-clinical laboratory studies (Ref.1). Clinical studies are governed by Good Clinical Practices (GCP), that are intended to protect human participant safety.

The most central aspects of GxP (Good Practice) guidelines are:

1. Traceability- the ability to reconstruct the development history of (in this case) an assay.
2. Accountability- the presence of a complete audit trail of activities and culpabilities.

Within a GLP study at FlowMetric, the QA unit represents an independent group that monitors the study from conduct, to analysis and reporting.  The conduct of a study encompasses the training of personnel performing the work, along with the calibration and maintenance of the equipment used. Data analysis and reporting under GLP ensures that the results were collected and analyzed as outlined in the study protocol. However, GLP does not define the scientific standards, or support any scientific hypothesis.  Under GLP, it is QA’s role to ensure that all written procedures are followed throughout the study, and any deviations from the plans are investigated, explained and corrective actions implemented.

Current FDA regulations do not require a QA element for projects such as method validations and clinical trial exploratory assays. However, at FlowMetric, all studies are performed under the guiding principals of GLP, and our QA department provides independent oversight of aspects of  project quality  from the adherence to standard operating procedures (SOP), controlled methods and project plans, to the adequate training of personnel and equipment calibration and maintenance.

For GLP-studies, QA unit conducts in-phase inspections during project execution. These in-phase audits establish that the QMS (project plan, controlled methods applicable SOPs, policies and procedures) are all adhered to. In addition, in-phase audits and comprehensive QC-reviewed reports and statements are provided for filing with the FDA or other regulatory authorities, as needed.  Other key aspects of these audits include the comprehensive documentation of many aspects of the workflow outlined in Figure 1.

Fig. 1. Core aspects of FlowMetric’s Quality Management System.

FlowMetric provides expertise in the assessment of the regulatory requirements of every Sponsor’s project. By providing our services under an umbrella of GLP-compliance, FlowMetric ensures that even exploratory studies are supported by the utmost caliber of performance and documentation. FlowMetric is committed to providing the highest quality of work to our clients, whilst complying with relevant national and international regulations and guidelines of GLP, and our QA unit is driven towards continual improvement across the entirety of our QMS.

Table1. Summary of FlowMetric’s services offered for various program types.

Ref. The US regulations can be found in 21CFR58 (1978), and European Union regulations can be found via the Organization for Economic Co-operation and Development (OECD), MonographNo.1. Oct. 1979.