Ongoing procedure performance verification (OPPV) of an analytical procedure is the process of ensuring it continues to meet its intended use after completion of validation. On the basis of previous studies, this paper further discussed the indicators of ongoing procedure performance verification (including system suitability indicators and reported values, etc.) and the implementation of analysis tools (control charts), and demonstrated the specific operation steps of ongoing procedure performance verification with examples. It is hoped that this paper will provide new ideas for the accurate and standardized procedure verification in the pharmaceutical field, especially in the enterprises and regulatory departments.
LI Na, DU Ying, GENG Ying, JIN Zhao-hui, QU Xiao-meng, NIE Xiao-qi, TAN De-jiang
. Discussion the ongoing verification indicators and evaluation approachs of analytical procedure[J]. Chinese Journal of Pharmaceutical Analysis, 2024
, 44(5)
: 916
-920
.
DOI: 10.16155/j.0254-1793.2024.05.21
[1] USP 46-NF 41 <1220> Analytical Procedure Life Cycle[S]. 2022
[2] ICH Q14 Analytical Procedure Development [EB/OL]. (2022-08-24) [2023-09-08] https://www.ema. europa. eu/en/ich-q14-analytical-procedure-development-scientific-guideline
[3] ISO 5725 Accuracy (Trueness and Precision) of Measurement Methods and Results—Part 6:Use in Practice of Accuracy Values[S]. 1994
[4] 中国食品药品检验研究院.中国药品检验标准操作规范[M]. 北京:中国医药科技出版社, 2019:714
National Institutes for Food and Drug Control. Chinese Drug Inspection Standard Operating Standards[M]. Beijing:China Medical Science and Technology Press, 2019:714
[5] 李娜,耿颖,谭德讲,等.分析方法确认和转移的评估标准探讨[J]. 药物分析杂志, 2021, 41(4):675
LI N, GENG Y, TAN DJ, et al. Discussion on the criteria for successful method verification and transfer[J]. Chin J Pharm Anal, 2021, 41(4):675
[6] USP 46-NF 41<1033> Biological Assay Validation [S]. 2022
[7] 李娜,杜颖,刘翠,等.生物活性检测方法的定义及分类辨析[J]. 药物分析杂志,2022, 42(6):931
LI N,DU Y, LIU C, et al. Definition and taxonomy of biological method[J]. Chin J Pharm Anal, 2022, 42(6):931
[8] 中华人民共和国药典2020年版. 四部[S]. 2020:61,206
ChP 2020.Vol Ⅳ[S]. 2020:61,206
[9] ZHU FG. Application of shewhart control charts in the inspection of pharmaceutical manufacturing process[J]. Int J Pharm Chem, 2019, 5(1):1
[10] 李娜,冯国双,段丽,等.OOS管理中的统计分析工具及其应用[J]. 中国食品药品监管, 2021(6):40
LI N, FENG GS, DUAN L, et al. Statistical analysis tools and their applications in OOS management [J]. China Food Drug Adm, 2021(6):40
[11] ICH Q2(R1). Validation of Analytical Procedures:Text and Methodology [S]. 2005
[12] PA/PH/OMCL (21) 26-Statistical analysis of results using CombiStats [EB/OL]. 2021 [2022-05-30]. https://www.edqm.eu/documents/52006/67492/Statistical+analysis+of+results+of+biological+assays+and+tests+-+PA_PH_OMCL+%2821%29+26.pdf/9281bbf2-f852-d0f5-9342-95ff25397946?t=1649409069892
[13] ASTM D6299. Applying Statistical Quality Assurance and Control Charting Techniques to Evaluate Analytical Measurement System Performance[S]. 2020
[14] ISO 7870-2. Control Charts-Part 2:Shewhart Control Charts[S]. 2023
