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美国时间9月11日，美国FDA官网发布新闻稿称对中国两家提供第三方非临床研究服务的公司发出警告信（warning letter），涉及的两家中国公司为位于中国天津的Mid-Link Testing Company,LTD（公司中文名应为：海河生物医药科技集团）和位于江苏苏州的Sanitation & Environmental Technology Institute dba SDWH（公司中文名应为：苏州大学卫生与环境技术研究所，简称：苏大检测）。在现场检查中发现两家机构存在实验室监督失误和动物护理违规行为，这些行为导致了对实验室产生的数据质量和完整性的担忧。
1、Mid-Link Testing Company,LTD（海河生物医药科技集团）
FDA针对海河生物的警告事项有六条，分别为：
1）The study director failed to assure that all experimental data, including observations of unanticipated responses of the test system are accurately recorded and verified, and unforeseen circumstances that may affect the quality and integrity of the nonclinical laboratory study are noted when they occur, and corrective action is taken and documented [21 CFR 58.33(b) and 58.33(c)].
2）Failure to conduct nonclinical laboratory studies in accordance with the protocols [21 CFR 58.130(a)].
3）Failure of a testing facility to have standard operating procedures in writing setting forth nonclinical laboratory study methods that management is satisfied are adequate to ensure the quality and integrity of the data generated in the course of a study. The study director failed to authorize all deviations in the study from standard operating procedures and ensure the deviations were documented in the raw data [21 CFR 58.81(a)]
4）Testing Facility Management failed to ensure that personnel clearly understand the functions they are to perform [21 CFR 58.31(f)]
5）Failure of the Quality Assurance Unit (QAU) to fulfill responsibilities [21 CFR 58.35(a),58.35(b)(1), 58.35(b)(5), and 58.35(b)(6)].
6）Failure to ensure that warm-blooded animals shall receive appropriate identification where all information needed to specifically identify each animal within an animal-housing unit appears on the outside of that unit [21 CFR Part 58.90(d)]
2、Sanitation & Environmental Technology Institute dba SDWH（苏州大学卫生与环境技术研究所有限公司，简称：苏大检测）
FDA针对苏大检测的警告事项同样有六条，分别为：
1）The study director failed to assure that (1) the protocol, including any change, is approved as provided by § 58.120 and is followed; (2) all experimental data, including observations of unanticipated responses of the test system were accurately recorded and verified; (3) unforeseen circumstances that may affect the quality and integrity of the nonclinical laboratory study were noted when they occurred, and corrective action was taken and documented; and (4) all raw data, documentation, protocols, specimens, and final reports were transferred to the archives during or at the close of the study; (5) all applicable good laboratory practice regulations are followed. [21 CFR 58.33(a), (b), (c), (e) and (f)].
2）Testing facility management failed to assure that there was a quality assurance unit as described in 21 CFR 58.35 and failed to assure that any deviations from these regulations reported by the quality assurance unit are communicated to the study director and corrective actions are taken and documented. [21 CFR Part 58.31(c), and 58.31(g)].
3）Failure of the Quality Assurance Unit (QAU) to fulfill responsibilities [21 CFR 58.35(b)(5), 58.35(b)(6), and 58.35(b)(3)]
4)Failure to ensure that each individual engaged in the conduct of or responsible for the supervision of a nonclinical laboratory study have the education, training, and experience, or combination thereof, to enable that individual to perform the assigned functions [21 CFR Part 58.29(a)(b)]
5)Failure of the testing facility to have standard operating procedures in writing setting forth nonclinical laboratory study methods that management is satisfied are adequate to insure the quality and integrity of the data generated in the course of a study. The study director failed to authorize all deviations in the study from standard operatingprocedures and ensure the deviations were documented in the raw data. The testing facility failed to establish standard operating procedures for animal room preparation, animal care, and test system observations, and failed to maintain a historical file of revisions to the standard operating procedures [21 CFR Parts 58.81(a)(b)(1-6) and (d)]; Failure to prepare a final study report that included (1) corrections or additions in the form of an amendment by the study director and (2) the name of study director, the names of other scientists or professionals, and the names of all supervisory personnel involved in the study. [21 CFR Part 58.185(a)(9),(c)].
6) Failure of the testing facility to ensure that all newly received animals from outside sources were isolated and their health status evaluated in accordance with acceptable veterinary medical practice. In addition, failure of the testing facility to ensure warm-blooded animals, excluding suckling rodents, used in laboratory procedures that require manipulations and observations over an extended period of time or in studies that require the animals to be removed from and returned to their home cages for any reason (e.g., cage cleaning treatment, etc.) received appropriate identification [21 CFR 58.90(b), 58.90(d)].
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发表于 2024-9-12 14:28:23
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