基于PTP认可能力范围的中国药品检验领域能力验证活动发展现状及建议

    Current Status and Recommendations for Proficiency Testing Activities in China's Drug Testing Field: Based on the Scope of PTP Accreditation Capability

    • 摘要:
      目的  深入分析中国药品检验领域能力验证活动的现状,针对现存问题提出合理化建议。
      方法 通过梳理近十年国内药品检验领域能力验证提供者(proficiency testing provider,PTP)的认可能力范围变化和具体项目实施情况等,揭示中国药品检验领域PTP在发展中所面临的主要困境。
      结果与结论 研究发现,虽然近年来中国药品检验领域PTP机构数量和认可范围不断扩大,但仍存在相似能力验证计划实施难易程度不一致、研发高水平能力验证计划动力不足、局部过剩竞争影响能力验证市场健康发展等关键问题。据此提出针对性对策建议,以期推动中国药品检验领域能力验证活动的健康发展。

       

      Abstract:
      OBJECTIVE  To deeply analyze the current status of proficiency testing activities in the field of drug testing in China and put forward reasonable suggestions in response to the existing problems.
      METHODS  By sorting out the changes in the accreditation scope of proficiency testing providers(PTPs) and the implementation of specific projects in the domestic drug testing field in the past decade, the main difficulties faced by PTPs in the development of the drug testing field in China were revealed.
      RESULTS & CONCLUSION  The research found that although the number of PTP institutions and the scope of accreditation in the field of drug testing in China had been continuously expanding in recent years, there were still some key problems, such as the inconsistent difficulty levels of implementing similar proficiency testing schemes, the lack of motivation to develop high-level proficiency testing schemes, and the impact of local excessive competition on the healthy development of the proficiency testing market. Based on this, targeted countermeasures and suggestions were put forward to promote the healthy development of proficiency testing activities in the field of drug inspection in China.

       

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