“《医疗机构制剂许可证》验收标准”有关条款难点探讨

"Acceptance Criteria for Pharmaceutical Preparation Certificate for Medical Institutions":Discussion of Difficulties in the Implementation of Relevant Items

目的:为进一步细化和完善“《医疗机构制剂许可证》验收标准”(简称“验收标准”)提供参考。方法:分析和探讨“验收标准”中有关条款的执行难点。结果:关于验证:能否有所侧重,处方工艺和质控方法的验证由医院承担,厂房设施和仪器设备的验证则主要依靠院外相关单位的技术支持;关于物料检验:尤其是药包材,能否主要由物料生产厂家提供《注册证》、质检报告和所有相关的验证资料,以替代内控检查,必要时申请复验;关于微生物限度检查:能否不局限于药剂科,而委托医院其它科室如检验科完成,以提高检验结果的可信限。结论:建议适当调整“验收标准”的有关条款,以符合我国医疗机构的现状,增加操作的可行性。

OBJECTIVE： To provide references for the further specification and improvement of the ＂acceptance criteria for Pharmaceutical preparation Certificate for Medical Institutions＂ （or ＂acceptance criteria＂ for short）. METHODS： Difficulties in implementing relevant items of ＂acceptance criteria＂ were discussed analytically. RESULTS： Concerning validation： it is advisable that the validation of formula technics and quality control be conducted by hospitals and that of factory building facilities and instrumentation mainly rely on the technical support from other relevant units. Regarding material test, it is advisable that the ＂registration certificate＂, quality inspection report and the related validation information be supplied by material manufacturers to substitute internal control examine. Regarding microbial limit examination, besides the department of pharmacy, whether it is possible to entrust clinical laboratory or other department within hospital for this test so as to boost the confidence interval of the test results. CONCLUSIONS： It＇s suggested that the related items in ＂acceptance criteria＂ be properly adjusted in accordance with the status quo of Chinese medical institutions so as to increase its practicability.