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Discussion the ongoing verification indicators and evaluation approachs of analytical procedure
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Na LI1, Ying DU2, Ying GENG2, Zhao-hui JIN1, Xiao-meng QU1, Xiao-qi NIE1, *, De-jiang TAN2, *
Chinese Journal of Pharmaceutical Analysis | 2024, 44(5) : 916 - 920
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Chinese Journal of Pharmaceutical Analysis | 2024, 44(5): 916-920
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Discussion the ongoing verification indicators and evaluation approachs of analytical procedure
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Na LI1, Ying DU2, Ying GENG2, Zhao-hui JIN1, Xiao-meng QU1, Xiao-qi NIE1, *, De-jiang TAN2, *
Affiliations
  • 1.Beijing Minhai Biotechnology Co., Ltd., Beijing 102609, China
  • 2.National Institutes for Food and Drug Control, NMPA Key Lab for Quality Research and Evaluation of Chemical Drug, Beijing 102629, China
Published: 2024-05-31 doi: 10.16155/j.0254-1793.2024.05.21
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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.

procedure verification  /  ongoing procedure performance verification  /  analytical procedure life-cycle  /  control chart  /  analytical control attributes
Na LI, Ying DU, Ying GENG, Zhao-hui JIN, Xiao-meng QU, Xiao-qi NIE, De-jiang TAN. 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
Year 2024 volume 44 Issue 5
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doi: 10.16155/j.0254-1793.2024.05.21
  • Receive Date:2023-11-20
  • Online Date:2026-03-20
  • Published:2024-05-31
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  • Received:2023-11-20
Affiliations
    1.Beijing Minhai Biotechnology Co., Ltd., Beijing 102609, China
    2.National Institutes for Food and Drug Control, NMPA Key Lab for Quality Research and Evaluation of Chemical Drug, Beijing 102629, China
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表12种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)

Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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