TGA BioServices provides a complete immunoassay validation package that is extensive and in compliance with FDA review. All work is performed under good laboratory procedure conditions (21 CFR Parts 58) and with CFR 320.29 and follows the basic parameters set forth in the “Guidance for Industry: Bioanalytical Methods Validation for Human Studies: FDA CDER: May 2001”.
Whether the system is a simple screening assay or a quantitative assay used in stability testing, performance characteristics can be defined and assay parameters implemented for day-to-day operation. Validations can be applied to bioassays, RIA’s, EIA’s and any other similar type of detection system. A typical validation package would include the following parameters:
Performance Characteristics – Parameters such as reproducibility, operator-to-operator variation, sample parallelism, sensitivity, specificity, beginning to end variation, assay ruggedness, spike and recovery, freeze-thaw effects and cutoff analysis can be performed to evaluate the performance of the particular assay.
Assay Acceptability Criteria – Acceptability parameters are established from the validation, which then are used for the determination of assay acceptability. Control charts are utilized to track assay performance and trends that may occur over time. By using this method, overall performance can be monitored assay-to-assay, operator-to-operator and day-to-day.
Supporting Documentation – Depending upon the client’s requirements, Standard Operating Procedures (SOP’s), worksheets and reagent logs are generated and incorporated into the TGA BioServices QA documentation system, resulting in full traceability of all analysis.
Database Formation and Handling – Specific macros are tailored to each project to ensure that all raw data is electronically transferred during database generation and statistical analysis, thereby eliminating manual input errors