立足PTP认可机构能力范围剖析我国药品检验领域能力验证活动发展的现状及建议

Analysis of the Current Status and Recommendations for the Development of Proficiency Testing Activities in Drug Testing Field in China from the Scope of PTP Accreditation Body Capability

关键词:  药品检验  能力验证  PTP认可  现状分析  发展对策

Key words:  drug testing  proficiency testing  PTP accreditation  status analysis  development strategies

摘要:

目的 本研究旨在深入分析我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的认可能力范围变化和具体项目实施情况等,揭示我国药品检验领域PTP在发展中所面临的主要困境。结果与结论 研究发现,虽然近年来我国药品检验领域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,以期推动我国药品检验领域能力验证活动的健康发展。

Abstract:

ABSTRACT: OBJECTIVE This study aims 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 AND CONCLUSIONS The research found that although the number of PTP institutions and the scope of accreditation in the field of drug testing in China have been continuously expanding in recent years, there are 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 are put forward to promote the healthy development of proficiency testing activities in the field of drug inspection in China.