2. Your firm failed to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods (21 CFR 211.165(e)).I guess "uh, we'll have someone else do the QC testing" won't fly as an excuse.
Your firm did not validate analytical test methods used to determine assay for the active ingredients in your drug product before release for distribution. Your notebook and high-performance liquid chromatography (HPLC) report included different instrumentation parameters for the same active ingredient analysis. For example, in the HPLC report the flow rate and injection amount for biotin was [redacted] mL/[redacted] and [redacted] µL, while in the notebook these parameters were recorded as [redacted] mL/[redacted] and [redacted] µL.
In your response, you stated, “In the main component analysis, other components besides the main component will be subjected to quantitative analysis and qualitative analysis through an external analysis institution”.
Your response is inadequate because you did not provide sufficient information regarding the validation of your test methods, including a timeframe to complete method validation and which analyses your third-party will be conducting. You also did not provide an interim plan of action.
Wednesday, February 6, 2019
Warning Letter of the Week: different HPLC conditions and other test methods edition
An epistle from the Center for Drug Evaluation and Research to the Chief Executive Officer of Soleo in Gyeonggi-do, Korea: