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Article Navigation >  Journal of Pharmaceutical Practice and Service  > 2012  >  30(5): 387-389

ZHAO Qing-hua, GONG Wei, WANG Ai-wu, ZHANG Zhen-xin. Analysis and countermeasures on the quality issues of the sampling inspection preparation of the Jinan Military Region in 2007~2011[J]. Journal of Pharmaceutical Practice and Service, 2012, 30(5): 387-389. doi: 10.3969/j.issn.1006-0111.2012.05.020
Citation: ZHAO Qing-hua, GONG Wei, WANG Ai-wu, ZHANG Zhen-xin. Analysis and countermeasures on the quality issues of the sampling inspection preparation of the Jinan Military Region in 2007~2011[J]. Journal of Pharmaceutical Practice and Service, 2012, 30(5): 387-389. doi: 10.3969/j.issn.1006-0111.2012.05.020
shu

Analysis and countermeasures on the quality issues of the sampling inspection preparation of the Jinan Military Region in 2007~2011

doi: 10.3969/j.issn.1006-0111.2012.05.020
  • 1.

    Institute for Drug and Instrument Control, Joint Logistics Department of Jinan Military Region, Jinan 250022, China

  • 2.

    Provincial Hospital Affiliated to Shandong University, Jinan 250021, China

  • Received Date: 2012-03-14
  • Rev Recd Date: 2012-07-17
  • Objective To analyse the quality issues of preparation in Jinan Military Region and improve the quality of preparation in medical institutions. Methods According to the 2007~2011 inspection records and the test results, the main quality problems of the preparation of medical institutions was summarized and analyzed. Results A total of 1 177 batches of preparation were inspected, among which 45 batches were unqualified, involving 15 kinds of formulations. Among the 56 unqualified projects, unqualified in Microbe Restriction Test was the most (39.29%)of the total, followed by unqualified in Assay (16.07%) and Loading Capacity (14.29%) with 6 kinds of unqualified reasons. Conclusions Aiming at the unqualified reasons, the medical institutions should further optimize the technology and processes and strict compliance with Good Manufacturing Practice to improve the quality standards of preparation and guarantee that the safe and effective medication of the masses and the officers and soldiers.
  • [1] 中国药典2010版.二部[S].2010:1070.
    [2] 中国人民解放军医疗机构制剂规范2002年版[S].2002:121.
    [3] 中国人民解放军医疗机构制剂规范2002年版增补本[S].2005:35.
    [4] 古卓良,傅小英.南京战区医疗机构制剂质量分析与对策[J].解放军药学学报,2008,24(2):187
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Analysis and countermeasures on the quality issues of the sampling inspection preparation of the Jinan Military Region in 2007~2011

doi: 10.3969/j.issn.1006-0111.2012.05.020
  • 1. Institute for Drug and Instrument Control, Joint Logistics Department of Jinan Military Region, Jinan 250022, China
  • 2. Provincial Hospital Affiliated to Shandong University, Jinan 250021, China
  • Received Date: 2012-03-14
  • Rev Recd Date: 2012-07-17

Abstract: Objective To analyse the quality issues of preparation in Jinan Military Region and improve the quality of preparation in medical institutions. Methods According to the 2007~2011 inspection records and the test results, the main quality problems of the preparation of medical institutions was summarized and analyzed. Results A total of 1 177 batches of preparation were inspected, among which 45 batches were unqualified, involving 15 kinds of formulations. Among the 56 unqualified projects, unqualified in Microbe Restriction Test was the most (39.29%)of the total, followed by unqualified in Assay (16.07%) and Loading Capacity (14.29%) with 6 kinds of unqualified reasons. Conclusions Aiming at the unqualified reasons, the medical institutions should further optimize the technology and processes and strict compliance with Good Manufacturing Practice to improve the quality standards of preparation and guarantee that the safe and effective medication of the masses and the officers and soldiers.

ZHAO Qing-hua, GONG Wei, WANG Ai-wu, ZHANG Zhen-xin. Analysis and countermeasures on the quality issues of the sampling inspection preparation of the Jinan Military Region in 2007~2011[J]. Journal of Pharmaceutical Practice and Service, 2012, 30(5): 387-389. doi: 10.3969/j.issn.1006-0111.2012.05.020
Citation: ZHAO Qing-hua, GONG Wei, WANG Ai-wu, ZHANG Zhen-xin. Analysis and countermeasures on the quality issues of the sampling inspection preparation of the Jinan Military Region in 2007~2011[J]. Journal of Pharmaceutical Practice and Service, 2012, 30(5): 387-389. doi: 10.3969/j.issn.1006-0111.2012.05.020
shu

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