No. FDA has observed at some drug manufacturers the practice of a trial injection where a sample of a lot is injected into the chromatographic system with the intention of obtaining an unofficial result (e.g., passing or failing). This is in contrast to the appropriate practice where an injection of a standard is performed with the sole intention of determining if the chromatographic system is fit for purpose. The injection of trial samples is not acceptable, in part, because all data analysis of product samples must be retained and reviewed (21 CFR 211.22, 211.165, 211.192, and 211.194). Furthermore, uncertainty about system performance may also suggest a potential insufficiency of the method’s design, validation status, analyst training, equipment maintenance, or other fundamental problem(s) in the laboratory that should be ly corrected.
Column conditioning does not involve injecting a sample a lot and is not considered a trial injection. When its use is scientifically justified, column conditioning should be fully described in the method validation package as to the conditions needed to make the measurement (i.e., based on data the method validation) and should be clearly defined in an approved and appropriate procedure. Only validated test methods that demonstrate accuracy, sensitivity, specificity, and reproducibility may be used to test drugs (21 CFR 211.165(e)). Consistent and unambiguous injection nomenclature should be used, and all data the column conditioning, including audit trail data, should be maintained and subject to review.
Therefore, FDA considers it a violative practice to perform a trial injection (including under the guise of column conditioning). FDA also considers it a violative practice to use an actual sample in test, prep, or equilibration runs as a means of disguising testing into compliance.
