Chinese Journal of Pharmaceuticals, Volume. 56, Issue 7, 970(2025)

Lifecycle of Pharmaceutical Analytical Methods and Drug Inspection

ZHOU Mengmeng, XU Changbo, and ZHAI Tiewei*
Author Affiliations
  • Center for Food and Drug Inspection of NMPA, Beijing 100076
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    References(9)

    [1] [1] ICH. Q2(R2) validation of analytical procedures [EB/OL]. (2023-11-01) [2024-08-28]. https://www.cde.org.cn/ ichWeb/guidelch/toGuideIch/1/0.

    [3] [3] WHO. TRS 1019-53rd report of the WHO expert committee on specifications for pharmaceutical preparations, appendix 4 analytical procedure validation [EB/OL]. (2019-06-01)[2024-08-28]. https://www.who.int/publications/i/item/WHO_TRS_1019.

    [5] [5] ICH. Q14 analytical procedure development [EB/OL].(2023-11-01) [2024-08-28]. https://www.cde.org.cn/ichWeb/guideIch/toGuideIch/1/0.

    [12] [12] ICH. Q10 pharmaceutical quality system [EB/OL]. (2008-06-04) [2024-08-28]. https://www.cde.org.cn/ichWeb/guidelch/toGuidelch/1/0.

    [13] [13] ICH. Q9 quality risk management [EB/OL]. (2023-01-18) [2024-08-28]. https://www.cde.org.cn/ichWeb/guideIch/toGuidelch/1/0.

    [14] [14] WHO. TRS 1052-57th report of the WHO expert committee on specifications for pharmaceutical preparations, who technical report series 1052, meeting report, annex 4 WHO good practices for pharmaceutical quality control laboratories [EB/OL]. (20224-04-26) [2024-08-28]. https://www.who.int/publications/i/item/9789240091030.

    [15] [15] FDA. Compliance program 7346. 832 preapproval inspections [EB/OL]. (2022-09-16) [2022-10-17]. https://www.fda.gov/media/121512/download.

    [16] [16] ICH. Q3A (R2): impurities in new drug substance [EB/OL].(2006-10-25) [2024-08-28]. https://www.cde.org.cn/ichWeb/guidelch/toGuideIch/1/0.

    [17] [17] ICH. Q3B (R2): impurities in new drug products [EB/OL].(2006-6-02)[2024-08-28]. https://www.cde.org.cn/ichWeb/guideIch/toGuideIch/1/0.

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    ZHOU Mengmeng, XU Changbo, ZHAI Tiewei. Lifecycle of Pharmaceutical Analytical Methods and Drug Inspection[J]. Chinese Journal of Pharmaceuticals, 2025, 56(7): 970

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    Paper Information

    Category:

    Received: Oct. 12, 2024

    Accepted: Aug. 26, 2025

    Published Online: Aug. 26, 2025

    The Author Email: ZHAI Tiewei (zhaitw@cfdi.org.cn)

    DOI:10.16522/j.cnki.cjph.2025.07.018

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